ANDA approves Glenmark Pharmaceuticals for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg

Glenmark Pharmaceuticals Inc | October 19, 2020

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune®1 Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV. According to IQVIATM sales data for the 12 month period ending August 2020, the Rapamune® Tablets, 0.5 mg, 1 mg and 2 mg market2 achieved annual sales of approximately $119.7 million*. Glenmark's current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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PHARMACY MARKET

Edenbridge Pharmaceuticals Announces the Launch of DARTISLA ODT

Edenbridge Pharmaceuticals | March 01, 2022

Edenbridge Pharmaceuticals, LLC announced that DARTISLA ODT is now available by prescription in the United States through Phil, the commercialization partner and eHub for DARTISLA ODT, as well as in retail pharmacies throughout the country. To ensure access to patients in need, Edenbridge is sponsoring the DARTISLA ODT Copay Program, which allows eligible patients to obtain the product for as little as $0 when filled through Phil or $20 when filled at other pharmacies. “DARTISLA ODT is the first and only FDA-approved orally disintegrating tablet of glycopyrrolate, and we are excited to introduce this novel formulation of glycopyrrolate to patients and healthcare providers,” noted Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and General Counsel. “Further, Edenbridge is committed to ensuring patient access to this product, and we are pleased to be sponsoring the DARTISLA ODT Copay Program to facilitate getting DARTISLA ODT into the hands of people that need it most.” “Phil is proud to support Edenbridge’s commitment to providing broad access to this innovative therapy by simplifying the patient onboarding process allowing affordable, fast, broad-based distribution of Dartisla ODT,” Deepak Thomas, Founder and CEO of Phil The U.S. Food and Drug Administration (FDA) approved Dartisla ODT for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer on December 16, 2021. DARTISLA ODT is manufactured by Catalent using their proprietary Zydis® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water. Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT. DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. About Edenbridge Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings. About Phil Phil is a commercialization partner for innovative life sciences companies, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers can provide patients with more affordable and timely therapy access.

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