Microsoft word - anticipatedfirsttime_generics.doc

Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

Estimated Dates of Possible First Time Generic/ Rx-to-OTC Market Entry
2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…

2010 US Retail
Brand Name
Generic name
Common use(s)
(in millions)^
^ Dollar amount reflects combined sales of all strengths and formulations of the product, unless otherwise indicated; source IMS Health 1 Several companies have announced the settlement of patent litigation relating to Desloratadine Tablets, 5 mg (Clarinex). Pursuant to these settlements, the generic manufacturers will have the right to market Desloratadine Tablets, 5 mg, in the U.S. on July 1, 2012, or earlier in certain circumstances. Clarinex and Clarinex D will likely be switched to OTC availability prior to generic availability. 2 Lexapro’s '712 patent was originally slated to expire in December 2009, which included an additional six months of pediatric exclusivity. The U.S. Patent & Trademark Office granted the patent an 828-day extension in March 2006. Therefore, the estimated date for generic availability changed to March 2012. A recent patent litigation decision has also sided with Forest, upholding the validity of a key patent on Lexapro and keeping generics off the market until patent expiration in 2012. 3 Generic Plavix was approved 1/20/06 with paragraph IV certification giving Apotex 180-day exclusivity. Apotex launched their generic “at risk” on August 8, 2006. A preliminary injunction was granted on August 31, ordering Apotex to halt its sales of generic Plavix. The judge did not require Apotex to recall clopidogrel that had already been distributed. Bristol-Myers Squibb/Sanofi’s patent infringement trial against Apotex began January 22, 2007. 4 Mylan launched their first-time generic for Xopenex inhalation solution 0.25% with 180 day exclusivity in September 2009. In April 2008, Breath Limited received FDA approval for their generic Xopenex inhalation solution 0.021%, .0042%, and 0.0103%. Sepracor settled a patent dispute with them which will allow Breath to market generic versions of the drug beginning August 2012 with a 180-day exclusive license. In March 2009, Sepracor entered into a Settlement and License Agreement with Teva and Barr. The agreement permits Barr and Teva to launch generic versions of Xopenex inhalation solution dosages under terms of a non-exclusive license commencing on February 17, 2013. 5 Diovan received pediatric exclusivity, extending the drug's patent protection in the US until September 2012. 6 Patent litigation is ongoing between Teva and Merck with regard to Temodar. The U.S. Court of Appeals for the Federal Circuit court is reviewing an appeal by Merck. If the Appeals court agrees that Merck’s patent for Temodar is unenforceable, Teva may launch their generic at any time. Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.
Estimated dates are subject to change due to patent litigation, additional patents, exclusivities…
7 Warner Chilcott sued Watson for patent infringement on Loestrin 24 FE in 2006. A
settlement was reached in January 2009. Warner Chilcott sued Lupin for patent
infringement on Loestrin 24 FE in September 2009.
8 In October 2007, Teva received FDA approval of its ANDA for Actonel 5 mg, 30 mg,
and 35 mg tablets but did not launch due to ongoing patent litigation. In February 2008,
the U.S. District Court for the District of Delaware found Procter & Gamble’s U.S. Patent
No. 5,538,122 covering Actonel to be valid. Teva intends to appeal this decision.
9 Boehringer Ingelheim sued Teva/Barr for patent infringement on Aggrenox in July
2007. The companies announced a settlement agreement in August 2008.
Note: Pulmicort dry powder inhalation and Advair have been removed from the table.
These both contain inhaled corticosteroids, and the FDA has not determined a standard
for bioequivalence for inhaled corticosteroids in multi-dose inhalers (MDIs) or dry
powder inhalers (DPIs). Therefore, generic availability may be significantly delayed. At
this time, there is no estimated date of generic approval.
Information current as of July 2011. Estimated dates are subject to change due to patent litigation,
additional patents, exclusivities…

Medco is a registered trademark of Medco Health Solutions, Inc.
2011 Medco Health Solutions, Inc. All rights reserved.

Source: http://www.krtv.com/files/genericdates.pdf