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The Earliest Date A U. S. Drug Can Go Generic


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#1 Jerod Poore

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Posted 23 August 2008 - 12:50 PM

Here's how you find out the earliest possible date a drug can go generic, or if it's available as a generic already. Now that I think about it, there's a really easy way to tell if a drug is available as a generic in the US. Just check the website of a major chain pharmacy. They'll tell you if the generic is available.

The FDA Electronic Orange Book will tell you all you need to know.

Start here. Select how you want to search by the drug's brand name(proprietary name) or generic name (active ingredient).


This page for the brand/proprietary name searches.

After that you'll get a page full of the drug's applications. You may see multiple listings for each dosage size. You may see one listing for each dosage size. There might be just one entry.

If you see anything under the "TE Code" Column (usually A, B or AB) then the drug is already available as a generic. Sometimes it is available as a generic for just one application or even one dosage! If all dosages are available as generic for one or more applications you can, or will probably get the generic regardless of what sort of brain cooties you have. Otherwise click on a link with the lowest Application number (as that is the most likely to have the soonest patent expiration date). Still you should check each Application number (only one per dosage is required) just to be sure.

The next page has information interesting only for patent and approval purposes, but doesn't tell us much. Click on the link to view Patent and Exclusivity Info. That will take you to the page that tells us the soonest a generic version can be made.

The more important date is the patent expiration date. Nothing is going to happen before the patent expires. A drug may have multiple patents and that's the sort of thing that can hold up the manufacture of a generic.

Next is the exclusivity date. That's the FDA's version of a patent, more or less. The FDA awards a company exclusive rights to sell a drug for a various periods of time (depending on use and circumstances). Sometimes that extends the patent, sometimes it doesn't. Regardless, both have to have expired before a drug can go generic.

That's it. That's the absolute soonest a generic version of a drug can go on the market, after the original patent and the current exclusivity date (it can be renewed, but they get only so many), plus there can be lawsuits to slow down the process.

Patent use codes and exclusivity codes will tell you what the official application would be for the soonest generic if there are some wildly different dates, but it's not as if some insurance companies would pay attention to that.

Generics manufacturers will file lawsuits to get patents and exclusivity dates overturned. That doesn't work very often, but it does now and then.

Edited by Jerod Poore, 24 September 2009 - 04:15 PM.
Thought of a better way to check for generics & editted title.

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#2 Jerod Poore

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Posted 13 July 2010 - 11:56 AM

Next is the exclusivity date. That's the FDA's version of a patent, more or less. The FDA awards a company exclusive rights to sell a drug for a various periods of time (depending on use and circumstances). Sometimes that extends the patent, sometimes it doesn't. Regardless, both have to have expired before a drug can go generic.


While looking for something else I think I now have a better way to describe exclusivity.

We'll often refer to slightly new drugs (e.g. Lamictal ODT) and getting the FDA approval for new treatments, especially for made-up conditions like shift work sleep disorder (I'm looking at you Provigil), as "patent extenders." Those are actually exclusivity extenders. The pioneering manufacturer then has to decide which is going to be more profitable, preventing generic versions from being approved due to the new exclusivity, or letting the generics be approved for the old application(s) / form and depend upon marketing, their sales force, and their relationships with insurance companies and HMOs to approve their brand for the new application, or prescribe the new form more often.
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Current meds: lamotrigine 300mg, topiramate 325mg, buspirone 60mg, protriptyline 60mg, EPA 600mg, methylphenidate 5-10mg, lorazepam 1mg PRN
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#3 Serpens

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Posted 13 July 2010 - 01:22 PM

It's important to note the difference between patent and exclusivity.

Patent is enforced by the US Patent Office, not the FDA. They are fixed length from when the patent is filed. Patents are usually filed on a compound for a particular use early in clinical development. Patents can also be applied to technologies and mechanisms and dosage forms, such as delivering a drug by an ODT, a patch, or a controlled release form. As such a drug could have a patent on the compound for treating a disorder (or several patents for several disorders), a patent on delivering the drug for a particular disorder via a particular route, and the technology involved in that route can be patented itself.

Exclusivity is enforced by the FDA. It is awarded on approval of a New Drug Application. In many cases, the exclusivity period is less than the life remaining on the patent. However, in some cases the exclusivity is longer - such as when a drug has had a very long development period. The FDA can reward a manufacturer by extending exclusivity, such as if the manufacturer does research to get pediatric approval, or approval for another use (eg, getting an antidepressant approved for OCD in addition to MDD). While exclusivity is in force, the FDA will NOT approve an ANDA from another company to let them sell a generic in the US.

In some cases, when exclusivity has lapsed, and patent has not, the FDA has approved generics for drugs still under patent - it is not their job to enforce patent law. Normally, companies would not due this, as they'd be violating the patent, and would be sued senseless. However, in recent years Teva has brought generics for several patent protected drugs to the market and sold them with approved ANDAs, taking advantage of long, drawn out legal cases to continue selling the drugs to offset litigation costs. For example, Teva was selling generic Protonix two years before the patent ran out. The lawsuits and complications of this make things difficult for consumers - insurance companies are leery of covering legally encumbered drugs, and can potentially face complications if they give preferential status to a patent-illegal generic. Fluctuating prices and availability also compound their hesitancy.
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#4 Jerod Poore

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Posted 14 July 2010 - 01:57 PM

Exclusivity is enforced by the FDA. It is awarded on approval of a New Drug Application. In many cases, the exclusivity period is less than the life remaining on the patent. However, in some cases the exclusivity is longer - such as when a drug has had a very long development period. The FDA can reward a manufacturer by extending exclusivity, such as if the manufacturer does research to get pediatric approval, or approval for another use (eg, getting an antidepressant approved for OCD in addition to MDD). While exclusivity is in force, the FDA will NOT approve an ANDA from another company to let them sell a generic in the US.


The FDA is anything it's inconsistent. Since its approval in 1996 Topamax has had five new or modified indications. It still has pediatric exclusivity for the various migraine patents.

In some cases, when exclusivity has lapsed, and patent has not, the FDA has approved generics for drugs still under patent - it is not their job to enforce patent law.


I understand why the FDA doesn't and shouldn't enforce patent violations, but approving generics for drugs that are still under patent is just wrong. As much as I dislike big pharma for pulling a bunch of shit to extend patents, and generic crazy meds are usually as good as the branded versions, that comes across as unconstitutional. The Constitution spells out just a few explicit things the federal gummit is supposed to do, and protecting intellectual property is one of them.

Normally, companies would not due this, as they'd be violating the patent, and would be sued senseless. However, in recent years Teva has brought generics for several patent protected drugs to the market and sold them with approved ANDAs, taking advantage of long, drawn out legal cases to continue selling the drugs to offset litigation costs. For example, Teva was selling generic Protonix two years before the patent ran out. The lawsuits and complications of this make things difficult for consumers - insurance companies are leery of covering legally encumbered drugs, and can potentially face complications if they give preferential status to a patent-illegal generic. Fluctuating prices and availability also compound their hesitancy.


Plus that weird situation with Teva being able to sell generic lamotrigine chewable wafers since 2005. When I looked through Lamictal's history of FDA paperwork there are a lot of duplicate filings for GlaxoSmithKline and SmithKline Beecham. Not so with the wafers, as only the paperwork from SmithKline Beecham exists. It's like when Microsoft let the registration for hotmail.com expire. They're lucky the guy to snagged it was willing to sell it back to them for the registration fee. Except it's the same situation for Lamictal XR. Only SmithKline Beecham paperwork exists and the patent is expired. Like regular Lamictal there are still a couple of current exclusivity codes. But no one other than GSK is marketing an XR version.
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#5 Serpens

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Posted 14 July 2010 - 02:36 PM

I understand why the FDA doesn't and shouldn't enforce patent violations, but approving generics for drugs that are still under patent is just wrong. As much as I dislike big pharma for pulling a bunch of shit to extend patents, and generic crazy meds are usually as good as the branded versions, that comes across as unconstitutional. The Constitution spells out just a few explicit things the federal gummit is supposed to do, and protecting intellectual property is one of them.


I agree. They shouldn't do it. Sorting out intellectual property issues and patent law isn't in their job description though. Issues of authorized generics (eg, another company reselling brand manufacturer pills) or licensed generics (patent holder granting permission to manufacture a generic) complicate and compound issues. They seem to take a blindered approach to it, looking very narrowly at the areas they have regulatory power over. Unfortunately, short of rewriting the law to give them the ability to review patent concerns in ANDA decisions, there's little to be done about the issue. It leaves us with the pharma companies slugging out multi-billion dollar, lawsuits in years of litigation, and insurance companies and patients trying to sort through the mess it makes in the marketplace.

Of course, then again, generic makers could, you know, not game the system.
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#6 Serpens

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Posted 15 July 2010 - 11:08 AM

Some additional material:

Reuters on Teva's strategy of patent challenging and releasing at-risk generics (2008)

Pathways to generic approval:
Posted Image
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#7 Classically_James

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Posted 02 December 2010 - 09:33 PM

Question: I noticed that Seroquel (for example's sake) has a patent expiration date of around 2012-13 for most dosages. However, there are pediatric patent dates listed with dates way out into 2015. So, is that pediatric date the new patent date for the actual drug, or is it some kind of marketing restriction? God, that didn't make much sense, but try to read it anyway. LOL Another way of putting it is: can no generic be made until 2015?

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#8 Serpens

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Posted 02 December 2010 - 10:31 PM

Question: I noticed that Seroquel (for example's sake) has a patent expiration date of around 2012-13 for most dosages. However, there are pediatric patent dates listed with dates way out into 2015. So, is that pediatric date the new patent date for the actual drug, or is it some kind of marketing restriction? God, that didn't make much sense, but try to read it anyway. LOL Another way of putting it is: can no generic be made until 2015?

James


The answer? Maybe.

If no one challenges the patents, then no generic until 2015 - however view the above image. If a generic manufacturer files a Paragraph IV and says their generic does not violate the 2015 patent, and the patent holder (AstraZeneca) either does not challenge it, or loses the challenge, the generic becomes available.

Seroquel is owned by AstraZeneca. They are, as Pharma companies go, the biggest bunch of patent gaming, legal system abusing bunch of scum in the market. AstraZeneca tends to challenge everything. They almost never settle, and they usually win.

So it's very unlikely to get a generic before 2015.
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#9 Deep Sea Philosopher

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Posted 03 March 2011 - 12:13 PM

I am confused about Seroquel XR. I have heard that a couple of companies have gotten their generic version approved. Will their versions be released in the meantime like Osmotica's Venlafaxine ER was while brand Effexor XR was still under patent?

Provigil is also confusing me. The various patents expire over the next fifteen years. I simply do not get why they released Nuvigil so soon if Provigil will not be having competition for over a decade.

I am horrible with insurance/Big Pharma/FDA bullshit, so my apologies for asking rudimentary questions.


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#10 dymphna

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Posted 04 March 2011 - 05:34 AM

I am confused about Seroquel XR. I have heard that a couple of companies have gotten their generic version approved. Will their versions be released in the meantime like Osmotica's Venlafaxine ER was while brand Effexor XR was still under patent?

Provigil is also confusing me. The various patents expire over the next fifteen years. I simply do not get why they released Nuvigil so soon if Provigil will not be having competition for over a decade.

I am horrible with insurance/Big Pharma/FDA bullshit, so my apologies for asking rudimentary questions.


DSP


I'll start with Provigil. Provigil is Modafinil, and is made by Cephalon. Nuvigil is Armodafinil and is also made by Cephalon. Armondafinil is the (−)-®-enantiomer of Modafinil, kind of like how Lexapro is the S-stereoisomer (enantiomer) of Celexa. (ergo: Escitalopram). I'm guessing it isn't so much about patent extending in this case as it is "hey, we can nail two markets: if Provigil doesn't quite work, rather than lose the customer, we can offer them Nuvigil".

Next, Effexor.

On the federal level, Congress should ensure that the FDAs Office of Generic Drugs is robustly funded so it has the resources needed to enable timely review of generic drug applications. American patients and payors, including the federal government and the states, lose billions of dollars each week that generic access is delayed. Access to new cost-saving generics also is facilitated through proconsumer and procompetitive drug patent litigation settlements. Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand name drugs expired. For instance, settlement of the patent suit involving the antiseizure medication Lamictal allowed generic lamotrigine to come to market 3 months prior to patent expiration, saving patients more than $190 million during the early launch period. Similarly, significant savings will be generated by the recent launch of generic Effexor XR, also made possible by settlement of patent litigation.

(Pharmacy Times)

(putting on my economist hat) On the surface, it would appear that pharma is losing money going from brand to generic. In reality, the reverse is true. By truncating if not eliminating lawsuits, there is a significant cost savings (Teva is famous for litigating their way into early release of generics) to patent holders. Additionally, they have heavily gotten into the "branded generic" market, both in the US and abroad. Although I find it terrifying that Dr. Reddy's is made by Glaxo Smith Kline...

And, on to Seroquel. AstraZeneca has already gone into agreement with India's Torrent to do branded drugs there, so I suspect you will be seeing the same thing happen.

Does that help?

You could spend hours wandering through all of the subsidiary companies and licensing agreements of the major and minor pharma companies. It is mind blowing.


D


I had this whole thing linked and sourced and it wouldn't let me post it until I took them ALL out. Just google "branded generics".
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#11 Jerod Poore

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Posted 07 March 2011 - 01:55 PM


Provigil is also confusing me. The various patents expire over the next fifteen years. I simply do not get why they released Nuvigil so soon if Provigil will not be having competition for over a decade.

I'll start with Provigil. Provigil is Modafinil, and is made by Cephalon. Nuvigil is Armodafinil and is also made by Cephalon. Armondafinil is the (−)--enantiomer of Modafinil, kind of like how Lexapro is the S-stereoisomer (enantiomer) of Celexa. (ergo: Escitalopram). I'm guessing it isn't so much about patent extending in this case as it is "hey, we can nail two markets: if Provigil doesn't quite work, rather than lose the customer, we can offer them Nuvigil".


There's also drug-drug interactions. Of all the crazy meds only Lovanza (pharmaceutical-grade omega-3 fish oil) - which isn't really a crazy med - does more with CYP450 enzymes than modafinil.
Provigil (modafinil) inhibits CYP2C19, does dose-dependent induction of CYP1A2, CYP2B6, and CYP3A4, and suppresses CYP2C9.
Nuvigil (armodafinil) is a moderate inducer of CYP3A4 and a moderate inhibitor of CYP2C19.

In that regard Nuvigil is to Provigil as Invega is to Risperdal. They do the same thing, but because Nuvigil isn't bioequivalent to Provigil Cephalon has to go through the whole clinical trials thing as if Nuvigil is a brand new drug. And that means they might get it approved for things Provigil failed, like adult ADD and as an antidepressant.
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Current meds: lamotrigine 300mg, topiramate 325mg, buspirone 60mg, protriptyline 60mg, EPA 600mg, methylphenidate 5-10mg, lorazepam 1mg PRN
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#12 Serpens

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Posted 08 March 2011 - 12:43 AM

In that regard Nuvigil is to Provigil as Invega is to Risperdal. They do the same thing, but because Nuvigil isn't bioequivalent to Provigil Cephalon has to go through the whole clinical trials thing as if Nuvigil is a brand new drug. And that means they might get it approved for things Provigil failed, like adult ADD and as an antidepressant.


Always a possibility. One thing Pharma companies do have to deal with now is the very real possibility of one of the generic manufacturers mounting a Paragraph IV challenge and busting patents on these drugs.

Different patents also apply to different aspects of the drug. They can cover the actual drug molecule (Drug Substance Claim), the product itself (eg, the pill formulation, XR gibberish Drug Product Claim), or the use of the drug (eg, using Seroquel for Schizophrenia). Different patents are easier or harder to for a generic company to beat.

For instance, Provigil is protected by a Drug Use claim until Oct 2014, and a Drug Product claim until 2023 (plus misc pediatric indications). Once that patent on the drug use expires, all that will be protecting Provigil is a patent on the pill itself. This makes it very likely that someone like Teva will be able to finagle a Paragraph IV challenge and get around that single remaining weaker patent.

By comparison, Nuvigil is protected by Drug Use until Oct 2014, and Drug Product (the pill itself) until late 2023. The caveat here is that there is ALSO a Drug Substance claim (on the Armodafinil molecule) until 2023 as well. From a generic maker's standpoint, this makes Nuvigil a much more daunting target, even though it's also losing a major patent in 2014.

As for ADHD... Well. Cephalon is going to have to handle this with kid's gloves. When they applied for ADHD approval on Provigil the FDA handed them one of the most vicious smackdowns in recent history, declining both pediatric and adult approval. The basis of this was a metabolic difference in adults and children, the higher doses needed for efficacy (>=500mg), and the incidence of SJS at this dose. They pegged a crude number at a possibility of 1300 additional cases a year of SJS if Provigil was approved for ADHD in peds. If they did it in adults only, the FDA CDER in a shocking display of competency, recognized that a very significant number of prescribers would just ignore even the strongest warnings and prescribe it to children anyway.

So yeah. Nuvigil for ADHD is a bit of a long shot as it presently stands.
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#13 Classically_James

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Posted 24 July 2011 - 10:21 PM

OK, here's another one: in the orange book it says Geodon's exclusivity date expiration is in 2012. However, the patent dates extend out to 2019. Therefore, theoretically a generic manufacturer could try to challenge with a generic after 2012. Correct?

James
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Diagnoses:

1. Major Depressive Disorder (MDD - atypical type)

2. Seasonal Affective Disorder (SAD)

3. Borderline Personality Disorder (BPD)(in partial remission)

4. Cotard's Delusion (removed prior to DSM IV in 1994(in partial remission)  

 

Medications:

1  Cymbalta (duloxetine DR) 60 mg QAM

2. BuSpar (buspirone) 15 mg QID

3. Desyrel  (trazodone) 150 mg QHS 

4. Xanax (alprazolam) 2 mg TID

5. Lunesta (eszopiclone) 3 mg QHS

6. Soma (carisoprodol) 350 mg TID


#14 horselover

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Posted 25 July 2011 - 03:31 PM

Here is a list of dates for drugs going off patent and generics possibly becoming available.
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#15 Serpens

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Posted 26 July 2011 - 08:04 PM

OK, here's another one: in the orange book it says Geodon's exclusivity date expiration is in 2012. However, the patent dates extend out to 2019. Therefore, theoretically a generic manufacturer could try to challenge with a generic after 2012. Correct?

James


Geodon has three pieces of protection that will expire in 2012 - two patents on the drug molecule (also covering the use for psychotic conditions), and FDA exclusivity. The Exclusivity expires in November. At this point the drug will be protected by only a claim on the product itself. This is a very weak claim, and one that could easily be challenged.

Technically, a generic maker can mount a Paragraph IV challenge at any time unless Exclusivity is in play (it is for Geodon).However, doing so when a patent is in effect on the drug molecule or substance itself is quite difficult, as they will generally have to proactively attack the patent itself and try to prove it invalid.

However, these challenges can take some time, and Geodon isn't the most popular atypical antipsychotic, and it's not owned by AstZen. There may be attempts to bring authorized generics on the market - which sucks for everyone involved. I'm rather shocked there's no controlled release version of it out yet.

But long and short of it, yes. Geodon will be a very attractive target at this point, as it would be only the 2nd generic AAP.
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#16 inmyhead

inmyhead

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Posted 19 November 2011 - 10:17 AM


In that regard Nuvigil is to Provigil as Invega is to Risperdal. They do the same thing, but because Nuvigil isn't bioequivalent to Provigil Cephalon has to go through the whole clinical trials thing as if Nuvigil is a brand new drug. And that means they might get it approved for things Provigil failed, like adult ADD and as an antidepressant.


Always a possibility. One thing Pharma companies do have to deal with now is the very real possibility of one of the generic manufacturers mounting a Paragraph IV challenge and busting patents on these drugs.

Different patents also apply to different aspects of the drug. They can cover the actual drug molecule (Drug Substance Claim), the product itself (eg, the pill formulation, XR gibberish Drug Product Claim), or the use of the drug (eg, using Seroquel for Schizophrenia). Different patents are easier or harder to for a generic company to beat.

For instance, Provigil is protected by a Drug Use claim until Oct 2014, and a Drug Product claim until 2023 (plus misc pediatric indications). Once that patent on the drug use expires, all that will be protecting Provigil is a patent on the pill itself. This makes it very likely that someone like Teva will be able to finagle a Paragraph IV challenge and get around that single remaining weaker patent.

By comparison, Nuvigil is protected by Drug Use until Oct 2014, and Drug Product (the pill itself) until late 2023. The caveat here is that there is ALSO a Drug Substance claim (on the Armodafinil molecule) until 2023 as well. From a generic maker's standpoint, this makes Nuvigil a much more daunting target, even though it's also losing a major patent in 2014.

As for ADHD... Well. Cephalon is going to have to handle this with kid's gloves. When they applied for ADHD approval on Provigil the FDA handed them one of the most vicious smackdowns in recent history, declining both pediatric and adult approval. The basis of this was a metabolic difference in adults and children, the higher doses needed for efficacy (>=500mg), and the incidence of SJS at this dose. They pegged a crude number at a possibility of 1300 additional cases a year of SJS if Provigil was approved for ADHD in peds. If they did it in adults only, the FDA CDER in a shocking display of competency, recognized that a very significant number of prescribers would just ignore even the strongest warnings and prescribe it to children anyway.

So yeah. Nuvigil for ADHD is a bit of a long shot as it presently stands.

What about money? Provigil has increased from $200, $500 in May, $600 in June, $750 today. Before it goes generic they will continue to raise the price ($800 soon). They maximize profit before expiration and present a similar low cost alternative: Nuvigil. Nuvigil is $350 today. If enough people switch to Nuvigil prior to Provigil going generic, they can potentially keep the AR(modafinil) revenue stream.
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