Viagra’s End Begins: Generic Sildenafil Launches For Revatio

Apotex has launched sildenafil for treatment of pulmonary arterial hypertension; its product is bioequivalent to Revatio, Pfizer’s sildenafil formulation for PAH, not Viagra; FDA also approved Watson, Dr. Reddy’s and Torrent sildenafil ANDAs.

Pfizer Inc.’s Viagra is in many ways the epitome of a lifestyle drug, and the end of its lifecycle may be as captivating as its launch in 1998.

Apotex Inc. launched generic sildenafil on Nov. 6, the day it received approval from FDA. While sildenafil is the active ingredient in Viagra, the generic is not indicated for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Legal & IP

More from Pink Sheet

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.