Generic Drug Companies Suing Each Other!
by Aaron F. Barkoff
Generic drug makers typically set their litigation sights on brand-name drug companies. Their goal is to invalidate the brand companies' patents and earn the right to market their generic drugs before the patents expire. Increasingly, however, generics are suing each other to protect or gain market share.
For instance, Teva Pharmaceuticals (TEVA) announced today that it recently sued several generic rivals who filed ANDAs for generic Zoloft (sertraline HCl), alleging that the companies infringe Teva's patents on processes for making sertraline HCl. Teva's 180-day generic exclusivity period expires next month and these lawsuits are an attempt to stave of generic competition. Teva filed suit against at least the following companies: Cipla; Hetero Drugs; Zydus-Cadila Healthcare; Sandoz; Andrx; Genpharm; Invagen; Lupin; and Apotex. Teva's complaint against Andrx, for example, alleges that if Andrx launches its generic Zoloft, it will infringe four Teva patents covering processes for making the form II and V polymorphs of sertraline HCl.
It was also recently reported that Lek D.D., a subsidiary of Sandoz, filed a complaint for patent infringement against Bristol-Myers Squibb (BMY) and Watson Pharmaceuticals (WPI) relating to BMS's Pravachol (pravastatin sodium). Lek's patents cover certain polymorphs of pravastatin sodium. Lek sells a generic version of Pravachol and Watson sells the authorized generic of Pravachol. While several other companies also sell generic Pravachol--including Teva, Apotex, Dr. Reddy's, Cobalt, Genpharm, and Pliva (Barr)--it is unclear whether Lek intends to sue any of them.
Another case of aggressive competition between generic drug companies involves Zofran (ondansetron HCl). As we reported Tuesday, Dr. Reddy's (RDY) recently launched the first generic version of ondansetron HCl tablets. Apotex had sought to launch its generic ondansetron HCl tablets at the same time as Dr. Reddy's, but the FDA denied Apotex's request and the courts upheld the FDA's decision. Apotex argued unsuccessfully that Dr. Reddy's 180-day generic exclusivity period came and went years ago, before the FDA had even granted tentative approval to Dr. Reddy's ANDA.
The trend of generics suing other generics appears likely to continue in the future, as generic drug companies boost spending on R&D and competition becomes more fierce. Investment in R&D will eventually lead to patents, which may wind up being asserted against other generic drug companies.
(This article was published by BioHealth Investor with permission of the author Aaron F. Barkoff of OrangeBookBlog.com)
RELATED READING:
- Apotex Loses Emergency Appeal, Dr. Reddy's Launches Generic Zofran
- Should Paying-Off Generics to Delay Launch of Competing Drugs be Prohibited?
- Indian Generic Drug Maker Targets Sad Americans
____________________
Generic drug makers typically set their litigation sights on brand-name drug companies. Their goal is to invalidate the brand companies' patents and earn the right to market their generic drugs before the patents expire. Increasingly, however, generics are suing each other to protect or gain market share.
For instance, Teva Pharmaceuticals (TEVA) announced today that it recently sued several generic rivals who filed ANDAs for generic Zoloft (sertraline HCl), alleging that the companies infringe Teva's patents on processes for making sertraline HCl. Teva's 180-day generic exclusivity period expires next month and these lawsuits are an attempt to stave of generic competition. Teva filed suit against at least the following companies: Cipla; Hetero Drugs; Zydus-Cadila Healthcare; Sandoz; Andrx; Genpharm; Invagen; Lupin; and Apotex. Teva's complaint against Andrx, for example, alleges that if Andrx launches its generic Zoloft, it will infringe four Teva patents covering processes for making the form II and V polymorphs of sertraline HCl.
It was also recently reported that Lek D.D., a subsidiary of Sandoz, filed a complaint for patent infringement against Bristol-Myers Squibb (BMY) and Watson Pharmaceuticals (WPI) relating to BMS's Pravachol (pravastatin sodium). Lek's patents cover certain polymorphs of pravastatin sodium. Lek sells a generic version of Pravachol and Watson sells the authorized generic of Pravachol. While several other companies also sell generic Pravachol--including Teva, Apotex, Dr. Reddy's, Cobalt, Genpharm, and Pliva (Barr)--it is unclear whether Lek intends to sue any of them.
Another case of aggressive competition between generic drug companies involves Zofran (ondansetron HCl). As we reported Tuesday, Dr. Reddy's (RDY) recently launched the first generic version of ondansetron HCl tablets. Apotex had sought to launch its generic ondansetron HCl tablets at the same time as Dr. Reddy's, but the FDA denied Apotex's request and the courts upheld the FDA's decision. Apotex argued unsuccessfully that Dr. Reddy's 180-day generic exclusivity period came and went years ago, before the FDA had even granted tentative approval to Dr. Reddy's ANDA.
The trend of generics suing other generics appears likely to continue in the future, as generic drug companies boost spending on R&D and competition becomes more fierce. Investment in R&D will eventually lead to patents, which may wind up being asserted against other generic drug companies.
(This article was published by BioHealth Investor with permission of the author Aaron F. Barkoff of OrangeBookBlog.com)
RELATED READING:
- Apotex Loses Emergency Appeal, Dr. Reddy's Launches Generic Zofran
- Should Paying-Off Generics to Delay Launch of Competing Drugs be Prohibited?
- Indian Generic Drug Maker Targets Sad Americans
____________________
posted by Nico at
7:41 AM
0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home