Orchid Pharma needs to resolve patent litigation with Forest Labs to sell memantine (Namenta) in US

India’s Orchid Chemicals & Pharmaceuticals  has received tentative approval to sell the generic version of the Alzheimer’s disease drug memantine hydrochloride tablets from US Food and Drug Administration (US FDA).

US FDA approval is for the 5mg and 10mg memantine hydrochloride tablets, according to Orchid Pharma.

Orchid’s memantine hydrochloride tablets are determined to be generic equivalent of Forest Laboratories’ Namenda tablets of similar strength.

Memantine is prescribed for the treatment of Alzheimer’s disease.

Orchid filed its abbreviated new drug application (ANDA) for this product under the Paragraph IV, First-to-file (FTF) certification.

The market size for memantine tablets is estimated to be around $1.1 billion.

Memantine tablets (Namenda) is under patent litigation between Orchid and Forest.

Apart from Orchid, Wockhardt is the other Indian generic firm which secured tentative approval to sell 5mg and 10mg memantine hydrochloride tablets in US.

Wockhardt and Forest Laboratories have reached a settlement on their patent litigation, which will allow Wockhardt to launch its generic version several months ahead of patent expiration or as soon as any other generic version is launched.

Forest Labs has been suing several generic companies, including firms from India, alleging that their abbreviated new drug applications (ANDA) under Para IV were infringing its patent on memantine (Namenda).

In January 2008, Forest Laboratories and its partner Merz Pharma filed several lawsuits against  generic firms including Lupin Ltd, Orchid Chemicals & Pharmaceuticals Ltd and Wockhardt Ltd,  Cobalt Laboratories, Teva Pharmaceuticals, Upsher-Smith Laboratories, Ranbaxy, Mylan and Barr Laboratories in the U.S. District Court for the District of Delaware as these companies tried to obtain marketing approval for memantine (Namenda).

US Patent ‘709 owned by Forest Labs and assigned to Germany-based Merz Pharma GmbH & Co. KGaA, covers formulations of adamantane derivatives that were manufactured and marketed as Namenda.

Forest has licensed the ’703 patent from Merz.

Headquartered in Chennai, India, Orchid Chemicals & Pharmaceuticals Ltd. is involved in the development, manufacture and marketing of diverse bulk actives, formulations and nutraceuticals. Orchid is the largest manufacturer-exporter of cephalosporin bulk actives in India and is ranked amongst the top 5-cephalosporin producers in the world.

Orchid’s world-class manufacturing infrastructure includes multiple USFDA compliant API and dosage form facilities at Chennai and Aurangabad in India. Orchid has dedicated state-of-the-art GLP compliant R&D centres for API research, drug discovery and pharmaceutical research at Chennai, India.

In September, Orchid Chemicals & Pharmaceuticals Ltd received approvals from the US Food and Drug Administration (US FDA) for its antibiotic combination piperacillin and tazobactam for injection, with 180-day exclusivity to market the products in US.

In December, Orchid Pharma sold its injectables business to Hospira, Inc, the world leading generic injectable firm, for nearly US $ 400 million.

Besides generic injectable finished-dosage form pharmaceuticals business, Hospira’s deal   includes Orchid’s beta-lactam antibiotics manufacturing complex and pharmaceutical research and development (R&D) facility at Irungattukottai, Chennai, as well as its generic injectable product portfolio and pipeline.

Orchid’s beta-lactam antibiotics manufacturing complex comprise cephalosporin, penicillin and carbapenem facilities.

Hospira is currentlt the world leader in generics injactables business responsible for  about 23 percent of the nearly $11 billion global generic injectables market. Hospira’s share is more than twice the share of its closest rivals.

In addition, the companies signed a long-term exclusive agreement for Orchid to supply active pharmaceutical ingredients (APIs) for the acquired generic injectable pharmaceuticals business.