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Viatris Inc. a global healthcare company, today announced that it and Kindeva Drug Delivery L.P. have won a significant court decision in which the U.S. District Court for the Northern District of West Virginia found that AstraZeneca’s Symbicort® patent, U.S. Patent No. 10,166,247, is invalid. The district court determined that the patent is invalid on two separate grounds – lack of written description and lack of enablement.
Viatris President Rajiv Malik said: “We are extremely pleased with the court’s decision as it clears away yet another of AstraZeneca’s invalid patents, which have only served to block generic versions and delay access to this important product for American patients. This affirms Viatris’ continuing efforts to break down barriers to patient access for important medicines. We already have FDA approval for our generic Symbicort product, and we look forward to the opportunity to bring our more affordable product to market.”
Today’s decision marks the fourth Symbicort® patent to be found either not infringed or invalid. In May, after Viatris and Kindeva won an appeal, AstraZeneca stipulated that the Company’s budesonide/formoterol fumarate dihydrate products would not infringe U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137.
Viatris and Kindeva previously announced that Mylan Pharmaceuticals Inc., a Viatris subsidiary, received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Breyna™ (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), the first approved generic version of AstraZeneca’s Symbicort®. Breyna, a drug-device combination product, is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD) and will be available in 160 mcg/4.5 mcg and 80 mcg/4.5 mcg dosage strengths.
AstraZeneca recently filed a new complaint asserting infringement of a fifth Symbicort® patent, which issued April 26, 2022, and shares the same specification and named inventors as the ‘247, ‘328, ‘239 and ‘137 patents. A trial on U.S. Patent No. 11,311,558 is currently scheduled for December 13, 2022. The ‘558 patent expires on January 29, 2023, with pediatric exclusivity expiring on July 29, 2023.
Viatris Inc. is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars and a variety of over-the-counter consumer products. With approximately 37,000 colleagues globally, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com.
Headquartered in Woodbury, Minnesota, Kindeva Drug Delivery is a leading global contract, research, development and manufacturing organization (CRDMO) in the pharmaceutical industry, with additional R&D sites in Union City, California and Loughborough, UK as well as major manufacturing sites in Northridge, California, Loughborough, UK and Clitheroe, UK. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, including metered-dose and dry power inhalers as well as nebulizer delivery, transdermal drug delivery, intradermal drug delivery, and connected drug delivery. Kindeva employs approximately 1,000 people worldwide. Learn more at www.kindevadd.com .
