Vista Pharmaceuticals had filed an ANDA in September 2017 Dofetilide (Brand: TIKOSYN) in financial partnership with M/s Biddle Sawyer, USA.
TIKOSYN (Generic: Dofetilide) is a CARDIAC drug which went OFF PATENT on 09 October 2018 and the drug molecule, TIKOSYN is owned by Pfizer.
Upon approval of Dofetilide ANDA, the company will join the exclusive club of other 4 Generic Manufacturers (Sun, Greenstone, Bion, Mayne/Sigma).
The size of the market is over USD 200 Million (Rs 1,400 crore approximately). The Company has completed all data filings and up to date in GDUFA fee payments for 2019 and is waiting for approval from US FDA for commercial launch of the product.
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