Apotex launches sitagliptin tablets and sitagliptin and metformin hydrochloride tablets, eligible for 180-day shared exclusivity

Apotex launches sitagliptin tablets and sitagliptin and metformin hydrochloride tablets, eligible for 180-day shared exclusivity

Apotex Corp. ("Apotex") today announced the U.S. launch of sitagliptin tablets and sitagliptin and metformin hydrochloride tablets, both of which are eligible for 180‑day shared exclusivity. These launches expand Apotex's portfolio of treatment options for adults living with type 2 diabetes mellitus. 

Apotex - Global Health Company

Type 2 diabetes affects millions of adults in the United States, and treatment often requires long-term, reliable access to prescribed therapies. 

Sitagliptin tablets are AB rated (per FDA's Approved Drug Products with Therapeutic Equivalence Evaluations) to JANUVIA® (Merck) and are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.1  

The product is available in 25 mg, 50 mg, and 100 mg strengths, packaged in 30‑count and 90‑count bottles. 

Sitagliptin and metformin hydrochloride tablets are AB rated to JANUMET® (Merck) and are indicated as a prescription medicine that contains a fixed-dose combination of sitagliptin and metformin hydrochloride, sitagliptin and metformin, and can be used as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes.2 The product is available in 50 mg/500 mg and 50 mg-1,000 mg count bottles. 

"Expanding access to high-quality, affordable medicines remain central to our mission," said Christine Baeder, President, Apotex USA and LATAM. "By introducing these products, we are seeking to strengthen the continuity of care for adults managing chronic conditions and supporting the healthcare professionals who rely on consistent, reliable treatment options for their patients." 

Both products are being made available through U.S. wholesalers and distributors. 

About Apotex

Apotex Corp., headquartered in Weston, Florida, is a subsidiary of Apotex Health Corp. We improve everyday access to innovative medicines and health products for millions of people around the world, offering a broad portfolio of generic and innovative pharmaceutical and consumer health products. Headquartered in Toronto, with regional offices globally—including in the United States, Mexico, and India—Apotex Health Corp is the largest Canadian based pharmaceutical company and a health partner of choice across the Americas for pharmaceutical licensing and product acquisitions.

Forward-Looking Statements

This press release may contain forward-looking information within the meaning of applicable securities laws. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events or circumstances. Forward-looking information in this news release includes statements regarding the exclusivity period of the launched products and our goal of expanding access to high quality, affordable medicines. This forward-looking information is based on a number of opinions, estimates and assumptions that, while considered by Apotex to be appropriate and reasonable as of the date of this release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause actual results to differ materially from those expressed or implied by such forward-looking information. Such risks and uncertainties include, but are not limited to, those related to the Apotex's ability to expand its portfolio with the product launches described herein, Apotex's ability to expand access to high‑quality, affordable medicines, Apotex's ability to achieve its mission, Apotex's ability to strengthen the continuity of care for adults managing chronic conditions and supporting healthcare professionals who rely on treatment options for their patients, Apotex's ability to improve everyday access to products, Apotex becoming the partner of choice across the Americas for licensing and product acquisitions and other risks. Apotex undertakes no obligation to publicly update or review any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required under applicable securities laws.

JANUVIA® and JANUMET® are registered trademarks of Merck Sharp & Dohme LLC.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/apotex-launches-sitagliptin-tablets-and-sitagliptin-and-metformin-hydrochloride-tablets-eligible-for-180-day-shared-exclusivity-302789161.html

SOURCE Apotex Corp.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2026/03/c5574.html

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