Shares of fully integrated pharmaceutical company Amneal Pharmaceuticals Inc (AMRX) raised +3.9% on Friday after ring of the bell. The new came on the heels of news about the company receiving an Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA).
What actually happened?
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The Bridgewater, NJ.-based AMRX manufactures, distributes, and develops generic and specialty pharmaceutical products. It works together to deliver high-quality medicines to patients primarily within the United States and also through activities in Asia, the European Union, and North America. Amneal has an extensive portfolio of 250 or more product families, and it continues expanding its product universe to cover a broad range of therapeutic areas, including biosimilars, in a variety of dosage forms. Also within the Company’s Specialty segment focused primarily on central nervous system and endocrine disorders, the Specialty segment markets a portfolio of branded pharmaceuticals as well.
Amneal on Friday announced that it had received FDA approval for a hybrid transdermal treatment containing 150mcg/day Norelgestromin and 35mcg/day Ethinyl Estradiol.
- Amneal has been awarded 180 days of exclusivity by the FDA concurrent with its approval as a Competitive Generic Therapy (CGT).
- There is a generic version of the reference listed drug (RLD) Ortho Evra in Amneal’s Norelgestromin and Ethinyl Estradiol Transdermal System.
- The product will be marketed as a 12.5 cm2 patch with a proprietary name called Zafemy.
- The product will be recommended to Women whose BMI is 30 kg/m2 or below and who are advised to use a combined hormonal contraceptive to avoid pregnancy.
- Females weighing more than 198 pounds (90 kg) may have less success preventing pregnancy with Zafemy.
- The company expects to start commercializing the product on March 1, 2021.
A leading healthcare data and analytics provider, IQVIA, calculates that the U.S. sales for all Xulane products were $332 million in the twelve months ended December 2020. Mylan’s Xulane is currently the only option available on the market, but Zafemy is the most complete alternative for the same which indicates growth opportunity for the newly launched product at an impressively high rate.