CI & Patent News:30/11/2010

1) Paragraph IV litigation

Astrazeneca Vs Mylan (product: Quetiapine ER)

Patent in suit: 5948437 (Expiry: May 28, 2017); Complaint filed at Northern District of West Virginia on Nov. 29, 2010. View on PriorSmart

Alza Corporation  Vs Impax Laboratories Inc & teva (Product: Methylphenidate ER)

Patent in Suit: 6930129 (Expiry: Jan 31, 2018); Complaint filed at District of Delaware on Nov. 24, 2010. View on PriorSmart

Impax had originally filed ANDA on Aug 17, 2005 and Alza  had sued Impax on ‘129 and another patent 6919373 (This case was dismissed by ALZA due to some reasons).  Now Impax amended its ANDA for which it got sued by alza on ‘129. Teva is distributor for Impax’s ANDA product in USA. (Note: Alza Vs ANDRX,  ‘373 patent got invalidated due to lack of enablement and which in appeal affrimed by CAFC).

Abbott Vs Impax (Simavastatin/Nicotinic acid; SIMCOR)

Patents in suit: 6080428, 6676967, 6406715, 6469035; Complaint filed at District of Delaware on Nov 24, 2010.

Jazz Pharmaceuticals Inc. v. Roxane Laboratories, Inc (Sodium Oxybate/Xyrem)

On November 22, 2010, Jazz has sued roxane at New Jersey District Court; Patents in Suit: 6780889, 7262219, 7668730, 7765106, 7765107; View on RFC; Roxane is first to file for Xyrem; (Jazz Press release)

Merck & Co., Inc Vs Hetero (Product: PROSCAR/Finasteride)

Complaint filed on New Jersey District Court on November 19, 2010; Patents (will be updated); View in RFC

2) Sun Pharma receives USFDA nod for generic Alzheimer’s drug (donepazil)

3) Bafna Pharma to invest Rs 30 cr in Specialty drugs (niche therapeutic segment of immunosuppressants)

… the company is looking to enter the niche therapeutic segment of immunosuppressants business by launching four products by the first quarter of 2011-12. These products have already been developed in collaboration with an Indian biotech major, and a tie-up has been signed with a marketing firm to sell the products in the Middle East and North African (MENA) region. The product would also be marketed in Brazil, Colombia, Sri Lanka and Philippines. However, he refused to divulge the details of its collaborations at this stage….

About Guna

Interested to learn things around me
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