Generic Provigil and Nuvigil

[diana.papshev]

Anonymous request:

"Have you released information on a generic for Provigil. With the release of Nuvigil, coupled with more that a 25% price increase of Provigil, it would be helpful to have some information on what is going on."

[chantell.reagan]

We previously reported on Provigil, but this update pertains to both Provigil and Nuvigil:



Provigil

First generic approval/launch forecast:

o Expected by 4/2012

Background, details, and sources:

o All currently listed patents expire by 5/2024 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification has been filed, starting in 2003 (Teva/Barr, Mylan, and Ranbaxy were first to file; Carlsbad/Watson, Apotex, Caraco, and Hikma also filed ANDAs with paragraph IV). Starting in late 2005, Cephalon settled with Teva, Ranbaxy, Mylan and Barr Laboratories to grant non-exclusive royalty-bearing marketing rights beginning in 4/2012. However, these settlements promoted multiple complaints (by FTC, direct and indirect purchaser class action, and Apotex) on the grounds of anti-trust violation; those legal proceedings are still ongoing. Note that Cephalon is not pursuing other ANDA filers in court (Sources: FDA paragraph IV list; Cephalon press release 2/2006; News article 3/2006; Orange Book Blog, 7/2006; Cephalon press release, 2/2008; Cephalon SEC filings (see 10-Q 10/28/09))
o FDA has issued tentative approvals for the generic modafinil by various manufacturers (Mylan, Teva, Barr, Carlsbad (Watson), Sandoz, Apotex, and Caraco), with Barr receiving the first in 1/04 (Sources: FDA paragraph IV list)

Nuvigil

First generic approval/launch forecast:

o Expected by 6/2024

Background, details, and sources:

o All currently listed patents expire by 6/18/2024 (Sources: FDA’s Orange Book)
o At least 1 ANDA with paragraph IV certification has been filed starting in 7/09 for the 50, 150, 250mg and in 9/09 for the 100, 200mg strengths (Mylan believes they are the first to file for the 50, 150 and 250mg dosage strengths, while Watson believes they are first to file for the 100 and 200mg strengths). Beginning in 12/09, Cephalon filed patent infringement lawsuits against Actavis, Mylan, Sandoz, Teva and Watson. At issue are the '570, '346 and '516 patents, which expire by 6/2024 (Sources: FDA paragraph IV list; Mylan press release 1/2010; Watson press release 1/2010; Cephalon press release 10/09;Cephalon press release 12/09; News article 1/2010; News article 12/2009; Cephalon SEC filings (see 10-Q 10/28/09 and 8K 12/15/09, 12/22/09))
o The FDA has not yet issued any approvals for generic equivalents (Sources: Drugs@FDA)

Note: Nuvigil is awaiting additional approval in the first half of 2010 for excessive sleepiness associated with jet lag disorder. For more information, visit DrugPipelineForecast.com