Generic OxyContin

[participant1]

What's the story with generic OxyContin?

[participant2]

A few months ago generic manufacturers stopped making the generic Oxycontin. Once the supply runs out there will only be the brand Oxycontin left on the market. The reason this happened was because there was a litigation and a court ruled that the generic should have never been released. Same story as Plavix.

[participant1]

Any update to this issue?

[chantell.reagan]

As of May 2008, there has been no update to the legal proceedings related to the patent challenges by the generic companies for Oxycontin. In January 2008, the court ruled in favor of Purdue, enforcing its patents.

The generic oxycodone products have been discontinued and currently Oxycontin is the only extended-release oxycodone product available on the market.

Sources:
Purdue Pharma Press Release; January 2008. Available at: Purdue Pharma Press release 1/08
Food and Drug Administration Cumulative Supplement; April 2008. Available at: Prescription and Over-the-Counter Drug Product List: Cumulative Supplement Number 2: April 2008 (see p. I29)

[andrew.maiorini]

We should be grateful that the Medication Patent Laws in this country are so clear and straightforward that there is never any need to spend millions of dollars on legal battles to determine when a drug "actually" loses its patent protection. Such an environment could negatively impact the timely release of cost-saving generic medictaions that save hundreds of millions of dollars.
Just imagine in such a system every generic release would be challenged and several products would have to be removed from the market further confusing people and causing therapy disruptions. I am so glad that.........

[diana.papshev]

Well, it looks like the confusion should be over - on July 24th, the FDA has approved an AB-rated generic of Oxycontin (strengths: 10, 20, 40, and 80 mg) made by Mallinckrodt.

[participant1]

But I guess we still have to wait till the generic actually hits retail shelves...

[jacqueline.kostick]

According to Mallinckrodt Pharmaceuticals, a launch date for the generic of OxyContin has not been projected yet.

[diana.papshev]

In anticipation of high demand, we decided to contact the FDA to clarify this issue in more detail. Here's the latest update:

Based on the informal conversation with a representative of the Office of Generic Drugs, it looks like this generic product won't get to retail any time soon. Due to some legal loopholes, Mallinckrodt's application was eligible for approval but they probably won't launch oxycodone extended release out of the fear for being sued by Purdue, especially considering that they are already involved in a litigation with them.

[diana.papshev]

Last week, Mallinckrodt and Purdue have reached an agreement, according to which Mallinckrodt will have a royalty-bearing license to sell limited quantities of the generic oxycodone hydrochloride extended-release tablets (10, 20, 40, 80 mg) until 2009 (starting this month). The agreement is subject to review by the Federal Trade Commission and the Department of Justice.

Sources:

Covidien press release. September 2, 2008.

Purdue press release. September 2, 2008

[SarahK]

I wonder exactly how limited the limited quantities will be?
As of this morning, I don't think the distributors have the generic yet.

[jacqueline.kostick]

Yesterday, we contacted Mallinckrodt to find out the specifics on the limited quantities and the details of the distribution, but they stated that they were unable to comment on the matter at this time.

[Nochmar]

Sounds almost like an authorized generic; looks like we can expect 10% off. I'll jump up and down later.

[g.ryan]

Would anyone have current information related to the patent expiration date for Oxycontin? We are processing claims for Mallinckrodt's oxycodone SR 10mg, 20mg, 40mg, and 80mg, and I'm unsure if this is the result of pharmacies depleting their stock, or if it represents the release of the generic. Any information would be appreciated. Thanks!

[Nochmar]

Temporary . . unfortunately

ST. LOUIS, June 9 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa; KVb) of St. Louis, MO., today announced it has entered into a settlement agreement with Purdue Pharma L.P. of Stamford, Conn., in regard to the patent infringement lawsuit between the two companies. Under the terms of the settlement agreement, KV Pharmaceutical Company acknowledges that Purdue Pharma's OxyContin(R) patents are valid and enforceable and infringed. In exchange, Purdue will grant KV Pharmaceutical Company certain limited non-exclusive, royalty-bearing, non-transferable rights to sell in the United States generic versions of the drug OxyContin(R) (oxycodone HCl controlled-release) for a limited period of time. The Companies have agreed to continue to discuss the final location for the manufacturing of this product.

[chantell.reagan]

It’s very timely that you’ve posed this question, because it came up in our June Webinar “Practical Guide to Forecasting Generic Drug Launches”.

Please note updated series of events re: OxyContin generic:

o Endo was first to submit ANDA with paragraph IV before 2004; Teva and Impax also challenged patents protecting Oxycontin
o Endo’s generic received final FDA approval in 3/2004 because contested patents were initially found to be unenforceable due to inequitable conduct by Purdue. Subsequently, FDA granted approvals to Teva and Impax
o Purdue filed lawsuits against all three generic manufacturers. When a higher court overturned the initial decision and patents were affirmed, litigation continued and all parties settled to phase out sales by 2007.
o Subsequently, Endo changed its ANDA to paragraph III to be eligible for FDA approval as soon as the affirmed patent (‘042) expires on 4/16/2013 (court affirmed patents in 1/2008).
o While in litigation with these generic manufacturers, Purdue also separately pursued other generic filers, including KV, Mallinckrodt, and Actavis. However, due to a legal loophole Purdue wasn’t able to file against Mallinckrodt within 45 days and this ANDA was technically granted a final approved in 7/2008.
o In 9/2008, Purdue settled with Mallinkckrodt; according to the terms of the settlement limited distribution of the authorized generic was to stop by the end of 2009
o In 6/2009, Purdue settled with KV. As Nochmar indicated above, the settlement allows for limited distribution of the authorized generic but the exact terms (quantity and duration) were not disclosed

Bottom Line:

o Prior to 4/2013, limited quantities of authorized generic might be in distribution from time to time (outcome of litigation between Purdue and Actavis is still pending)
o After 4/2013, Endo should receive final approval for their generic version of Oxycontin

Sources:

Orange Book Blog 8/2006
FDA tentative approval letter to Endo, 2/2007
Purdue Pharma press release, 1/2008
PatentDocs, 1/2008
Purdue Pharma press release, 9/2008
PatentDocs, 6/2009

[pburt]

Originally Posted by chantell.reagan

It’s very timely that you’ve posed this question, because it came up in our June Webinar “Practical Guide to Forecasting Generic Drug Launches”.

Please note updated series of events re: OxyContin generic:

o Endo was first to submit ANDA with paragraph IV before 2004; Teva and Impax also challenged patents protecting Oxycontin
o Endo’s generic received final FDA approval in 3/2004 because contested patents were initially found to be unenforceable due to inequitable conduct by Purdue. Subsequently, FDA granted approvals to Teva and Impax
o Purdue filed lawsuits against all three generic manufacturers. When a higher court overturned the initial decision and patents were affirmed, litigation continued and all parties settled to phase out sales by 2007.
o Subsequently, Endo changed its ANDA to paragraph III to be eligible for FDA approval as soon as the affirmed patent (‘042) expires on 4/16/2013 (court affirmed patents in 1/2008).
o While in litigation with these generic manufacturers, Purdue also separately pursued other generic filers, including KV, Mallinckrodt, and Actavis. However, due to a legal loophole Purdue wasn’t able to file against Mallinckrodt within 45 days and this ANDA was technically granted a final approved in 7/2008.
o In 9/2008, Purdue settled with Mallinkckrodt; according to the terms of the settlement limited distribution of the authorized generic was to stop by the end of 2009
o In 6/2009, Purdue settled with KV. As Nochmar indicated above, the settlement allows for limited distribution of the authorized generic but the exact terms (quantity and duration) were not disclosed

Bottom Line:

o Prior to 4/2013, limited quantities of authorized generic might be in distribution from time to time (outcome of litigation between Purdue and Actavis is still pending)
o After 4/2013, Endo should receive final approval for their generic version of Oxycontin

Sources:

Orange Book Blog 8/2006
FDA tentative approval letter to Endo, 2/2007
Purdue Pharma press release, 1/2008
PatentDocs, 1/2008
Purdue Pharma press release, 9/2008
PatentDocs, 6/2009

What is the status of the Purdue vs Actavis litigation over generic oxycodone?
All of the previous "Y" products are now listed as "M" in Medispan. Therefore there is no true "generic" left.

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[chantell.reagan]

We received this add-on question from one of our users:
“Recently all former "generic" oxycodone HCL CR/ER products moved from "Y" to "M" in Medispan and all former "O" brand versions also moved to "M". Is this because none of the former generic products had approved ANDA's on file with the FDA?”

There are no currently available FDA-approved generic Oxycontin products available on the market, as of 4/10. As we previously reported above and according to Drugs@FDA, the only FDA fully-approved generic was granted to Mallinkrodt in 7/08, but distribution has stopped as of 2009. Endo and Impax are listed as having tentative approvals until patents expire by 4/2013.

Bottom line:

o Prior to 4/2013, limited quantities of authorized generic might be in distribution from time to time based on the outcome of litigation between Purdue and generic manufacturers. As of 4/10, no information could be found in the public domain regarding the outcome of litigation between Purdue and Actavis.
o After 4/2013, Endo and Impax should receive final approval for their generic version of Oxycontin

Of note, a re-formulated version of Oxycontin was just approved by FDA 2 weeks ago – at this point it’s unclear how this strategy might affect entry of generic alternatives.