Amneal Launches US Rival To Butrans
Receives 180 Days Of Competitive Generic Therapy Exclusivity
Following approval by the FDA, Amneal has launched a generic version of the Butrans buprenorphine transdermal system, immediately initiating commercialization activities across all strengths.
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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.
After launching several high-value complex generic products in the last six months, Amneal aims to launch eight more complex generics by August 2021 to add “tremendous value” to its generics business.
Based on its “solid track record of filing, getting approval and launching high-value generics,” Amneal not only plans to launch eight new “high value” products over the next year, the company also plans to file for another 20-25 generics. Amneal has 91 products in the pipeline awaiting FDA approval and 132 products actively in development, mainly in non-oral solid dosage forms.