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TICAGRELOR

ANDA

TICAGRELOR | A208576 | ALEMBIC PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BRILINTA(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AstraZeneca AB et al v. Alembic Pharmaceuticals Ltd. et al 1:2022cv01216 1 patentANDA 208576ticagrelor	D. Del.	2022-09-16	Terminated 2022-12-30	—
AstraZeneca LP et al v. Alembic Pharmaceuticals LTD et al. 1:2015cv01003 1 patentANDA 208576ticagrelor	D. Del.	2015-10-30	Terminated 2015-11-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain45 active DMFs2 inactive

37 active API suppliers hold Drug Master Files for this ingredient.

PHARMARESOURCES (KAIYUAN) CO LTDTICAGRELOR INTERMEDIATE, 2-((3AR, 4S, 6R, 6AS)-6-AMINO-2, 2-DIMETHYLTETRAHYDRO-3AH-CYCLOPENTA [D] [1,3] DIOXOL-4-YLOXY) ETHANOL L-TARTARIC ACID (1:1) (CAS:376608-65-0)

DMF 281102014

PHARMARESOURCES (KAIYUAN) CO LTDTICAGRELOR INTERMEDIATE, 4, 6-DICHLORO-2-(PROPYLTHIO) PYRIMIDINE-5-AMINE (CAS: 145783-15-9)

DMF 281112014

PHARMARESOURCES (KAIYUAN) CO LTDTICAGRELOR INTERMEDIATE, (1R, 2S) -2- (3,4-DIFLUOROPHENYL) CYCLOPROPANAMINE (R)-2-HYDROXY-2-PHENYLACETATE (1:1) (CAS: 376608-71-8)

DMF 281122014

DR REDDYS LABORATORIES LTDTICAGRELOR

DMF 284462014

ZAKLADY FARMACEUTYCZNE POLPHARMA SATICAGRELOR

DMF 286742014

HEC PHARM CO LTDTICAGRELOR NON-STERILE BULK DRUG SUBSTANCE

DMF 287872015

MATRIX PHARMACORP PRIVATE LTDTICAGRELOR

DMF 288122014

HONOUR LAB LTDTICAGRELOR

DMF 288792015

TAPI NL BVTICAGRELOR

DMF 288802015

ALEMBIC PHARMACEUTICALS LTDTICAGRELOR

DMF 288992015

LEK PHARMACEUTICALS DDTICAGRELOR

DMF 289152015

ZHEJIANG HISUN PHARMACEUTICAL CO LTDTICAGRELOR

DMF 289232014

MSN ORGANICS PRIVATE LTDTICAGRELOR (FORM-II) [ROUTE CODE "TG2"]

DMF 289382015

CHANGZHOU PHARMACEUTICAL FACTORYTICAGRELOR

DMF 289842015

MICRO LABS LTDTICAGRELOR

DMF 290122015

RAKS PHARMA PVT LTDTICAGRELOR

DMF 290652015

WUHAN ZY PHARMACEUTICAL CO LTDTICAGRELOR

DMF 295682015

TARO PHARMACEUTICAL INDUSTRIES LTDTICAGRELOR

DMF 314822018

JIANGXI SYNERGY PHARMACEUTICAL CO LTDTICAGRELOR

DMF 316202017

JUBILANT PHARMOVA LTDTICAGRELOR

DMF 323992018

UNICHEM LABORATORIES LTDTICAGRELOR

DMF 335632019

NEULAND LABORATORIES LTDTICAGRELOR FORM-II

DMF 337482019

SICHUAN QINGMU PHARMACEUTICAL CO LTDTICAGRELOR

DMF 342102019

COHANCE LIFESCIENCES LTDTICAGRELOR

DMF 344202019

MSN ORGANICS PRIVATE LTDTICAGRELOR

DMF 346992020

CHANGZHOU PHARMACEUTICAL FACTORYTICAGRELOR (ROUTE CODE: TG)

DMF 348352020

PHARMARESOURCES (KAIYUAN) CO LTDTICAGRELOR

DMF 349182020

USV PRIVATE LTDTICAGRELOR

DMF 357672021

INNOVARE LABS PRIVATE LTDTICAGRELOR

DMF 361662021

DIVIS LABORATORIES LTDTICAGRELOR

DMF 367012022

MANKIND PHARMA LTDTICAGRELOR

DMF 367112022

SHANGHAI HUILUN PHARMACEUTICAL CO LTDTICAGRELOR

DMF 374382023

MACLEODS PHARMACEUTICALS LTDTICAGRELOR

DMF 386192023

CTX LIFE SCIENCES PVT LTDTICAGRELOR

DMF 386582023

VIYASH LIFE SCIENCES PRIVATE LTDTICAGRELOR

DMF 389652024

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDTICAGRELOR

DMF 390512023

LINHAI TIANYU PHARMACEUTICAL CO LTDTICAGRELOR

DMF 395692024

BIOCON LTDTICAGRELOR PH. EUR

DMF 395722024

SHAOXING JINGXIN PHARMACEUTICALS CO LTDTICAGRELOR

DMF 396262024

CHANGZHOU PHARMACEUTICAL FACTORYTICAGRELOR INTERMEDIATE (CODE TGA-B-4)

DMF 396792024

CHANGZHOU PHARMACEUTICAL FACTORYTICAGRELOR INTERMEDIATE (TGC R-MANDELATE)

DMF 401782024

MOREPEN LABORATORIES LTDTICAGRELOR

DMF 403212024

HONOUR LAB LTDTICAGRELOR (PROCESS-II)

DMF 418332025

LEE PHARMA LTDTICAGRELOR

DMF 419892025

ALKEM LABORATORIES LTDTICAGRELOR

DMF 426672025

PHARMARESOURCES (KAIYUAN) CO LTDInactiveTICAGRELOR (CAS: 274693-27-5)

DMF 284562014

AVRA LABORATORIES PVT LTDInactiveTICAGRELOR

DMF 339372019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 20, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 90MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 1, 2025

No patent or exclusivity listings for this strength.

#002 — 60MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2025