Amneal submits ANDAs to FDA for three key complex generic products
Amneal has submitted ANDAs to the Food and Drug Administration for the following three complex generics:
- Injectable propofol emulsion, the generic version of Diprivan, is an I.V. general anesthetic and sedation drug. Amneal plans to manufacture propofol emulsion internally by leveraging the company’s global injectables infrastructure.
- Bimatoprost ophthalmic solution, the generic version of Lumigan, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
[Read more: Amneal touts 26 generic new product launches in 2022]
- Albuterol sulfate inhalation, the generic version of Proair HFA, is indicated for the treatment or prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease. All trademarks are the property of their respective owners.
“We continue to make excellent progress advancing our pipeline of complex, high-value medicines. The filing of applications for three new complex generics are additional proof points in our successful innovation journey. Today, about 90% of our generics R&D pipeline is made up of complex products. As we move up the value chain of product complexity, we are adding new and sustainable long-term growth drivers to our diversified portfolio,” said Chirag and Chintu Patel, co-CEOs of Amneal.
Albuterol sulfate inhalation had a market value of $814 million, Bimatoprost ophthalmic solution, 0.01% had a market value of $779 million and Propofol emulsion injectable had a market value of $311 million, per IQVIA May 2023 data.