FDA Approves Generic Version of Sildenafil, Aminocaproic Acid

The FDA has given a final approval for generic versions of sildenafil (Revatio, Amneal Pharmaceuticals, Inc) for oral suspension 10 mg/ml and aminocaproic acid (Amicar, Amneal Pharmaceuticals, Inc.) tablets USP, 500 mg. Amneal has begun commercialization activities, the company said in a press release.

“We are pleased to bring these important medications to patients and health care providers,” said Chintu Patel, co-CEO of Amneal Pharmaceuticals. “Our large and diverse pipeline has now delivered 36 new generic products to the market in 2019 across numerous dosage forms.”

The FDA had previously granted a Competitive Generic Therapy (CGT) designation for Amneal’s generic version of aminocaproic acid. As the first approved application, Amneal has been granted 180 days of CGT exclusivity.

According to the press release, US market annual sales for the 12 months ended September 30, 2019, for sildenafil citrate oral suspension and aminocaproic acid 500 mg tablets were estimated to be approximately $180 million and $23 million, respectively.

Reference

• Amneal Announces the Approval and Launch of Generic Revatio® for Oral Suspension and Generic Amicar® Tablets [press release]. Biospace website. Bridgewater, NJ. Published December 2, 2019. https://www.biospace.com/article/releases/amneal-announces-the-approval-and-launch-of-generic-revatio-for-oral-suspension-and-generic-amicar-tablets/. Accessed December 4, 2019.