Alembic Pharma, a leader in branded generics in India, has received the approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market in the US Candesartan Cilexetil tablet (32 mg) — the generic version of Atacand which is used for treatment of hypertension and heart failure.
According to global information and technology services company IMS, Candesartan Cilexetil (32 mg) has an estimated market size of $27 million in the US.
Alembic Pharmaceuticals, which aims to file 100 ANDAs with the USFDA in the next three years, now has a total of 57 ANDA approvals from the US health regulator under its belt.
Generic drug applications in USFDA are termed as “abbreviated” as they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically show that their product is bioequivalent.
Alembic Pharmaceuticals recently won a patent infringement case in the US against Novartis AG and Mitsubishi Tanabe Pharma Corp, who had accused the Indian pharmaceutical company to have infringed their patent on multiple sclerosis drug Gilenya.
This allowed Alembic to bring its generic fingolimod products to the US market sooner than otherwise possible.