In a major boost to those who advocate cheap generic medicines, Lupin has received final approval from the United States Food and Drugs Administration (US FDA) for its Vyfemla tablets (Norethindrone and Ethinyl Estradiol tablets USP, 0.4mg/0.035 mg) which are a generic version of Warner Chilcott Company’s Ovcon 35 tablets.
Lupin’s Vyfemla is a contraceptive for women. The original developers of the oral contraceptive tablets had whopping annual US sales of approximately USD 22.3 million, a scale which stands threatened now.
To add to the celebrations at Lupin’s headquarters in Mumbai, USFDA yesterday also approved the generic version of Allergan Inc’s Zymaxid Ophthalmic Solution in the US market.
The Solution, which is the generic equivalent of Zymaxid Ophthalmic Solution of Allergan, is indicated for the treatment of bacterial conjunctivitis and is slated to gain immensely with 180 days of marketing exclusivity under Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments), since Zymaxid Ophthalmic Solution had annual US sales of around Rs. 3,85,76,16,000 (IMS MAT June 2013 data) .
Lupin, in order to avoid unwanted competition, focuses on less competitive segments in the US market including oral contraceptives, ophthalmology and dermatology. The Mumbai-based company has already done over 10 filings with the USFDA for ophthalmological products.
The company’s cumulative abbreviated new drug application filings with the USFDA as of 30 June 2013 stood at 177. According to reports majority of them are lined up for approval and as many as 86 have already received approvals to date.