Estimating Generic Availability for Protonix

[diana.papshev]

During the June 2009 Webinar (see more details here), the following questions were submitted, we’d like to open them for a general discussion in our community:

“Can you explain the Protonix situation?... Please provide update on Protonix at risk”

[diana.papshev]

The case of generic Protonix tablets is another example of at-risk generic launches after the expiration of the 30-month stay.

The following is the sequence of events to date in this case:

o Teva and Caraco/Sun were first to submit ANDA with paragraph IV in 2/2004
o Wyeth and Altana (now Nycomed) pursued both companies in court
o Although litigation was ongoing, the FDA granted final approval with 180-day exclusivity to both companies after the expiration of the 30-month stay period (Teva: 8/2007, Caraco/Sun: 9/2007)
o In 9/2007 Wyeth and Altana (now Nycomed) were denied preliminary injunction against Teva and Caraco/Sun seeking to prevent the “at risk” launches. This decision was further upheld in the court of appeals in 5/2009
o In 12/2007, Teva announced at-risk launch of its generic pantoprazole. Note that initially there was a standstill agreement with Wyeth. After the termination of this agreement in 1/2008, Teva announced that it will not re-launch or ship additional units of pantoprazole; however, substantial revenue from the sales of generic pantoprazole were mentioned in Teva’s 2008 annual report
o In 1/2008, Wyeth launched its authorized generic
o In 1/2008, Caraco/Sun announced at-risk launch of its generic pantoprazole. Substantial revenue from the sales of generic pantoprazole were also mentioned in Sun/Caraco’s 2008 annual report
o After the expiration of the 30-month stay period on another ANDA with paragraph IV, the FDA granted final approval to KUDCo in 3/2009 but the company hasn’t launched its generic yet
o The original patent infringement case will consolidate all at-risk launches; at issue is the ‘579 patent, which is set to expire on 1/19/2011. The trial date has not been scheduled yet; however, Wyeth anticipates that litigation could occur prior to the end of 2009

Bottom line

o At least 3 generic pantoprazole tablet versions should be available until the end of 2009
o At this point the status of generic availability is unpredictable from late 2009 to 1/2011. If the ‘579 patent is defeated in court, these generic products will continue to be sold unless Wyeth succeeds on appeal. But, if the ‘579 patent is affirmed, Wyeth will seek damages and sales of generic products may be phased out – in that case it’s uncertain whether Wyeth will continue marketing its authorized generic and/or if generic companies will decide to appeal
o By 1/19/2011, generic pantoprazole should be available

What are your thoughts? What has been your experience? Any additional comments for your peers?

Sources:
Drugs@FDA
FDA tentative approval letter to Teva, 4/2006
FDA's Orange Book
Teva press release 12/2007
Teva press release 1/22/2008
Teva press release 1/30/2008
Teva press release 2/2008
Wyeth press release 1/2008
Sun press release 1/2008
Teva press release 5/2009
2008 Wyeth annual report
2008 Teva annual report
2008 Caraco annual report

[chantell.reagan]

As of last week, the U.S. District Court of NJ "rendered positive findings" in a trial involving the '579 patent, "rejecting allegations by several generic companies [including Sun and Teva] that the patent was obvious". The final decision could be still be appealed.

Sources:
Nycomed press release 4/10
News article 4/10

[chantell.reagan]

An additional update:

•Sun is discontinuing their at-risk generic as of 5/5/10 (News article 5/10)
•Though Teva hasn't d/c their generic (as of 5/20/10), according to their available products, they did mention in their annual report that they "could be required to pay damages relating to the sale of its pantoprazole sodium tablets and be enjoined from further selling those products until patent expiry”
•According to the Pfizer/Wyeth 10-Q report (5/13/10), they intend to seek injunction against the continuation of sale of the [at-risk] generics, but there was no information as to whether they were planning on stopping sale of their authorized generic
•The ‘579 patent (which was affirmed) does expire 1/19/2011