Amneal Launches Amicar Rival With CGT Exclusivity
Also Introduces US Rivals To Revatio And Carafate
After receiving FDA approval for its generic aminocaproic acid with 180 days of exclusivity under the agency’s Competitive Generic Therapy pathway, Amneal has launched the rival to Amicar. At the same time, it has also begun selling a generic version of Revatio and has also claimed the first generic rival to Carafate.
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With Amneal already on the market and Lannett disclosing plans for a US filing, partners VistaPharm and Clayton Pharmaceuticals have scooped the second ANDA approval for a generic to Allergan’s Carafate oral suspension – the first with a competitive generic therapy designation.
As Amneal’s generics segment sees significant growth, the company has revealed plans to launch new products and expand in new markets. “We are extremely proud of the progress our company has made since we re-joined as leaders of Amneal,” said Chirag and Chintu Patel, co-CEOs of Amneal.
Amneal is set to benefit from 180 days of US exclusivity for its norelgestromin and ethinyl estradiol contraceptive patch product after receiving FDA approval with a competitive generic therapy designation. The generic will be the only competitor to Mylan’s Xulane version.