Pramipexole - Mirapex

[cvs1966]

Any idea when Pramipexole might become multi-sourced causing price to drop? I do know that Teva launched 1-4-2010. Are there more to follow?

[chantell.reagan]

Upon the launch of generic pramipexole, it appears that Teva's 180 day exclusivity started on 1/4/2010. There are currently 3 other manufacturers who have received tentative approval for their generics, including Mylan, Alembic and Glenmark. In 12/09, it was stated that Glenmark's product would be available by 10/2010 at the latest. By our calculations it looks like generics could be approved as early as 7/5/2010 (post 180 day exclusivity).

Sources:
Drugs@FDA
Barr's FDA approval letter
Teva product launches
Seeking Alpha news article 7/08
Dance with Shadows news article 12/09

[diana.papshev]

In the latest development, Federal Circuit court ruled that Mirapex patent ('812) is valid and enforceable, overturning earlier decision by lower court. Boehringer was awarded damages and now technically the Teva/Barr generic pramipexole is in violation of this patent, which is listed in the Orange Book to expire in 10/8/2010.

Teva has not made an official statement on this ruling but it's US website still lists generic pramipexole as being available.

Bottom line, we probably won't see other generics before 10/2010 and it's also possible that Teva's product might be withdrawn until that time.

[chantell.reagan]

This week, FDA gave final approval to 8 other generic manufacturers (including Mylan, Sandoz, Watson, etc) for generic pramipexole. Companies have also started shipment this week.

Additional sources:
FiercePharma news 10/10
MoneyLife news 10/10