Drugs Pharma

US regulatory nod for Lupin’s HIV drug in the works

Lupin Pharma

HQ Team

January 17, 2023: Pharma major Lupin told shareholders that it had received a so-called ‘tentative approval’, from the United States Food and Drug Administration (FDA), to market medicines used to treat HIV/AIDS.

The tentative regulatory nod permits Lupin to market generic versions of Dolutegravir and Rilpivirine tablets in the United States.

Dolutegravir and Rilpivirine tablets, used to treat HIV infections, had estimated annual sales of USD666m in the US (IQVIA MAT September, 2022), per the 16 January regulatory statement.

Lupin is the third-largest pharmaceutical company in the US by prescriptions, it added.

Lupin’s Mumbai-traded shares have gained some 16.6% over the past six months to INR752.55 on the NSE, valuing the developer of branded and generic formulations at around INR344.32bn.

Lupin operates 15 manufacturing sites, 7 research centers, and employs 20,000 professionals globally. The company claims it enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and that it has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.

Last week, the firm told investors that its respiratory and injectables portfolios were driving a “substantial diversification” of its generics business. Lupin also said it is “positioned” to “outperform” the Indian pharmaceutical market, with inorganic growth targeting mid-size companies, brands and portfolios.

Mumbai-headquartered Lupin made four acquisitions in 2022. The company bought Southern Cross’ generic business in Australia, Anglo French’s vitamin mineral supplement brands in India,  Sunovion Pharma’s respiratory brands ‘Brovana’ and ‘Xopenex’ in the US, and Bausch Health’s CNS and oncology brands in Brazil, per the 11 January presentation.

Lupin reported annual sales of USD2.2bn in FY22, when it invested 8.7% of its revenue in research and development.

Pharmaceuticals is a $22bn market in India with a historical 11% compound annual growth rate (CAGR), and Lupin has a 3.5% share of that pie, per the company’s 11 January investor presentation. The market is projected to reach $30bn by 2025 and $60-70bn by 2030. ENDS//

Leave a Reply

Your email address will not be published. Required fields are marked *