1. Generics Bulletin
  2. >>Products
  3. >>Generics

Numerous US Approvals Received By Lupin Following 278% Quarterly Profits Raise

Analysts Posit That Lupin Has Peaked For The Year

 
• By Chloe Kent

Lupin has announced a number of drug approvals in the US, as well as a biosimilar partnership in the Middle East and the launch of a novel fixed-dose triple combination drug in its native Indian market.

FDA approved concept
Lupin has recieved FDA approval for five different generic drugs • Source: Shutterstock

Recent weeks have seen Indian generics giant Lupin Limited receive numerous approvals from the US Food and Drug Administration. Since the release of its financial results for the second quarter of its 2024 financial year at the beginning of November, Lupin has received five approvals for generic drugs.

Key takeaways:

  • Recent weeks have seen Lupin secure approvals from the US Food and Drug Administration for five generic drugs: bromfenac ophthalmic solution, ganirelix acetate injection, pitavastatin tablets, dapagliflozin and canagliflozin

  • The firm has also partnered with Amman Pharmaceutical Industries to market its biosimilar ranibizumab across the Middle East, and launched the novel Vilfuro-G (vilanterol, fluticasone furoate and glycopyrronium bromide) in India

  • These announcements come

Particularly significant is the approval of its abbreviated new drug application to market a generic version of Bausch & Lomb’s Prolensa (bromfenac ophthalmic solution)

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Generics

Hikma Eyes $5bn Sales Target As It Sets Out Plans To 2030

 
• By Dave Wallace

Unveiling a new name for its generics business, Hikma has at the same time set out medium-term financial goals for its business that include three-year growth objectives for its sales and profits, as well as aiming at a $5bn turnover target by 2030.

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

 
• By Anju Ghangurde

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.

Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit’

 
• By Dean Rudge

Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

More from Products

Gedeon Richter: General Medicines Unit Deserves ‘More Attention And Credit’

 
• By Dean Rudge

Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.

Amgen Locked Out Of Canadian Eculizumab Market Until 2027

 
• By Dean Rudge

Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.