Aurobindo to share 180-day exclusive marketing rights for generic atomexetine (Strattera) in US

Indian generic firm Aurobindo Pharma received tentative approvals for its abbreviated new drug application (ANDA) under Para IV certification for atomexetine hydrochloride 10 mg, 18 mg, 25mg, 40 mg, 60 mg, 80 mg and 100 mg strengths with first to file status from US FDA.

Aurobindo Pharma’s atomexetine hydrochloride is the generic equivalent of Eli Lilly’s Strattera to treat attention deficit/hyperactivity disorder (ADHD) in children aged 6 and older, teens and adults.

Strattera  or atomoxetine hydrochloride, a norepinephrine reuptake inhibitor, is a non-stimulant medication.

Atomexetine hydrochloride (Strattera) has market size of approximately US$ 500 million for the twelve months ending March 2009, according to Newport.

Aurobindo’s first-to-file status entitles it to hold 180-day exclusive marketing rights for generic atomexetine hydrochloride in US.

Aurobindo Pharma, however, said it would share the 180-days maarketing exclusivity with other generic companies subject to the final approval and launch based on the pending litigation with Eli Lilly.

In August 2007, Eli Lilly filed suit in the District Court of New Jersey against Actavis for filing of an ANDA to manufacture a generic version of Lilly’s Strattera (atomexetine hydrochloride).

Later on, Eli Lilly filed an amended complaint in the case, adding additional ANDA/Paragraph IV filers Glenmark Pharmaceuticals, Sun Pharmaceuticals, Sandoz, Mylan Pharmaceuticals, Apotex, Aurobindo Pharma, Teva Pharmaceuticals, Synthon Laboratories, and Zydus Pharmaceuticals.  Sandoz had previously filed suit against Lilly seeking declaratory judgment of non-infringement and invalidity of the patent at issue.

In its complaint Eli Lilly asked that the US FDA’s approval be blocked until its patent expires on May 26, 2017. The disputed patent (patent number 590) covered the method of treatment and was issued by the US patent office on August 19, 1997.

In December 2007, Lilly and Zydus reached an agreement and consent judgment was entered on December 12, 2007. Eli Lilly arrived at comparable agreement with Glenmark later in July 2008. In June, 2008, Lilly dismissed Synthon Laboratories by stipulation.

Aurobindo Pharma has also recieved final approvals for ribavirin pills from the US FDA.

Aurobindo’s generic ribavirin tablets 200 mg and capsules 200mg are respective therapeutically equivalent versions of Hoffman La Roche’s and Schering Corporation’s branded products Copegus and Rebetol capsules.

Ribavirin is an anti-viral drug used to treat adult chronic hepatatis C patients who have compensated liver disease and has not been previously treated with interferon alpha.

Ribavirin has a market size of around US$90 million for the twelve months ending March, according to Newport figures.

Aurobindo plans to launch ribavirin tablets and capsules shortly in the US market, the company said in a communique.

With atomexetine and ribvirin approvals Aurobindo Pharma now has a total of 105 ANDA approvals from US FDA. Among the total 105 approvals, 76 are final and 29 are tentative, the company said.

Headquartered at Hyderabad, India, Aurobindo Pharma Limited is the largest Active Pharmaceutical Ingredients (API) manufacturer under FDA approved facility. Aurobindo is also one of the leading manufacturers of penicillin & cephalosporine products.

Aurobindo’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. Aurobindo is leading manufacturer of generic pharmaceuticals, as well.

Aurobindo’s product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics.

Aurobindo is marketing these products in over 100 countries.