Endo Begins Shipment of Authorized Generic Version of Colcrys® (colchicine, USP) in the United States

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Jul 02, 2018, 07:30 ET

DUBLIN, July 2, 2018 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), has begun shipping an authorized generic version of Takeda Pharmaceutical's Colcrys^® (colchicine, USP) 0.6 mg tablets. Endo's subsidiary, Endo Ventures Limited, entered into an exclusive U.S. supply and distribution agreement with Takeda Pharmaceuticals U.S.A., allowing Par to launch and distribute an authorized generic of the product.

Colcrys^® (colchicine, USP) 0.6 mg tablet is indicated for prophylaxis and treatment of gout flares in adults and familial Mediterranean fever (FMF) in adults and children 4 years or older.ⁱ

Colcrys^® is a trademark of Takeda Pharmaceuticals U.S.A., Inc., registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

Important Safety Information

COLCRYS can cause serious side effects or death if levels of COLCRYS are too high in your body. Taking certain medicines with COLCRYS can cause your level of COLCRYS to be too high, even at recommended doses, especially if you have kidney or liver problems.
Tell your healthcare provider about all your medical conditions and all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements, and if you consume grapefruit juice.
Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children.
COLCRYS can also cause serious muscle problems and blood disorders even when taken as directed. You have a higher chance for muscle problems if you are elderly, are taking certain other medicines with COLCRYS, or have kidney problems.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
The most common side effects in people who have gout flares are diarrhea (23%) and throat pain (3%).

Use of COLCRYS

COLCRYS (colchicine, USP) 0.6 mg tablet is a prescription medicine used in adults to prevent and treat gout flares.
COLCRYS is not a pain medicine and should not be taken to treat pain related to other conditions.

Individual results may vary.

Please see the complete Prescribing Information and Medication Guide and talk to your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

About Par Pharmaceutical
Par Pharmaceutical, headquartered in Chestnut Ridge, NY, develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Par, among the top four leaders in the U.S. generics industry, possesses a portfolio that includes sterile injectables, alternative dosage forms and many other differentiated products. Par is advancing a research and development (R&D) pipeline of more than 200 potential new products. Par is an operating company of Endo International plc. Learn more at www.endo.com or www.parpharm.com.

References:
ⁱCOLCRYS (colchicine, USP) Prescribing Information. Takeda Pharmaceuticals.