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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 208531


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NDA 208531 describes TICAGRELOR, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal, Apotex, Changzhou Pharm, Dr Reddys, Hisun Pharm Hangzhou, Invagen Pharms, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sciegen Pharms Inc, Sunshine, Taro, and Watson Labs Inc, and is included in seventeen NDAs. It is available from twenty-three suppliers. Additional details are available on the TICAGRELOR profile page.

The generic ingredient in TICAGRELOR is ticagrelor. There are twenty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for 208531
Tradename:TICAGRELOR
Applicant:Amneal
Ingredient:ticagrelor
Patents:0
Pharmacology for NDA: 208531
Mechanism of ActionCytochrome P450 3A4 Inhibitors
P-Glycoprotein Inhibitors
P2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 208531
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TICAGRELOR ticagrelor TABLET;ORAL 208531 ANDA Amneal Pharmaceuticals NY LLC 69238-1134 69238-1134-1 100 TABLET in 1 BOTTLE (69238-1134-1)
TICAGRELOR ticagrelor TABLET;ORAL 208531 ANDA Amneal Pharmaceuticals NY LLC 69238-1134 69238-1134-6 60 TABLET in 1 BOTTLE (69238-1134-6)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength90MG
Approval Date:Jan 23, 2019TE:RLD:No
Regulatory Exclusivity Expiration:Oct 28, 2025
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Oct 28, 2025TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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