Hatch-Waxman Tracker Update

New cases added:

• Avandaryl: SmithKline Beecham v. Teva
• BenzaClin: Dow Pharma Sciences v. Dermik Labs
• Eloxatin: Sanofi-Aventis v. Sandoz; S-A v. Dabur Pharma; S-A v. Teva
• Paxil CR: SmithKline Beecham v. Mylan
• Prevacid SoluTab: Takeda v. Teva
• Protonix: Altana Pharma and Wyeth v. Teva
• Solareze: Bioglan Pharms and Jagotec v. Novartis Consumer Health
• Ultram ER: Purdue et al. v. Par (07-255); Purdue et al. v. Par (07-414)

Pending cases updated:

• Abilify: Otsuka v. Teva
• Aciphex: Eisai v. Dr. Reddy's and Teva
• Actos: Takeda et al. v. Alphapharm et al.; Takeda et al. v. Sandoz
• Allegra/Allegra-D: Aventis et al. v. Sandoz
• Alphagan P: Allergan v. Apotex
• Ambien CR: Sanofi-Aventis v. Mutual Pharma
• Depakote ER: Abbott v. Wockhardt; Abbott v. Impax
• Effexor XR: Wyeth v. Sandoz
• Exelon: In re Rivastigmine Patent Litigation
• Fosamax: Merck & Co. v. Apotex
• Lipitor: Pfizer v. Teva
• Lotrel: Novartis v. Teva
• Norvasc: Pfizer v. Apotex
• Optivar: MedPointe Healthcare v. Sun Pharma
• OxyContin: Purdue Pharma et al. v. KV Pharma
• Pepcid Complete: McNeil PPC et al. v. Perrigo
• Plavix: Sanofi-Synthelabo et al. v. Apotex
• Prilosec: In re Omeprazole Patent Litigation
• Seroquel: AstraZeneca v. Teva
• Singulair: Merck Sharp & Dohme v. Teva
• Risperdal: Janssen Pharmaceutica et al. v. Mylan
• Zantac Syrup: Glaxo v. Cypress Pharma

Cases removed:

• Diastate/Diastate AcuDial: Xcel Pharms v. Kali Labs (settled)
• Prozac Weekly: Eli Lilly v. Barr Labs (settled)

As always, thanks to everyone who contributed information for this update!

Comments

[Madhu]

This is great. Can you post any information about ongoing litigation between King and Lupin and the chances of Lupin winning?

[Sean]

It appears the FDA is now publishing a list of all Para IV certifications. (Maybe they have always done this, but if so, I didn't know about it...). They don't identify the filer, but they do give the innovator and the date of filing of the Para IV certification.

http://www.fda.gov/CDER/ogd/ppiv.htm