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In a regulatory filing, Alembic Pharmaceuticals said it has received tentative approval by the US Food and Drug Administration (USFDA) for both Empagliflozin and Linagliptin pills in the strengths of 10 mg/5 mg and 25 mg/5 mg.
Alembic Pharma stated it is now in litigation with Boehringer at District Court of Delaware and launch of the product will be contingent on litigation outcome.
Quoting IQVIA info, Alembic Pharma said Empagliflozin and Linagliptin pills, 10 mg/5 mg and 25 mg/5 mg possess an estimated market size of USD 244 million to 12 months ending June 2020.
Alembic currently has a total of 130 ANDA approvals (113 closing blessings and 17 tentative approvals) out of USFDA.
Shares of Alembic Pharmaceuticals were trading 1.95 percent higher at Rs 1,010.10 apiece on the BSE.
