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TICLID

NDA

TICLOPIDINE HYDROCHLORIDE | N019979 | ROCHE PALO ALTO LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov — 5 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis NCT05047172	Phase 3	Active	University of Florida	1,683	2022-08-02 → 2027-01-31
Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)NCT05566301	—	Recruiting	IRCCS Policlinico S. Donato	1,140	2021-09-02 → 2030-12-31
Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent NCT05418556	Phase 4	Recruiting	Asan Medical Center	3,944	2022-10-21 → 2032-12-31
The Pharmacokinetics and Pharmacodynamics Study of Evategrel CG-0255 Besylate）and Plavix® in Healthy Participants NCT07619885	Phase 1	Recruiting	Shanghai CureGene Pharmaceutical Co., Ltd.	136	2026-06 → 2026-12
HR-MRI-Directed Tirofiban Therapy for Late-Window Acute Ischemic Stroke (TIAN)NCT07379190	Phase 3	Recruiting	Weifang Medical University	458	2026-06-22 → 2029-05-01
Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization NCT07512960	Phase 3	Recruiting	Fondation Hôpital Saint-Joseph	614	2026-06-12 → 2030-11-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLTICLOPIDINE HYDROCHLORIDE

DMF 104921993

CURIA ITALY SRLTICLOPIDINE HYDROCHLORIDE

DMF 126431997

ORGAMOL SAInactiveTICLOPIDINE

DMF 35991979

SANOFI SYNTHELABO INCInactiveTICLOPIDINE HYDROCHLORIDE

DMF 79751989

SANOFI SYNTHELABO INCInactiveTICLOPIDINE HYDROCHLORIDE

DMF 96381992

ERREGIERRE SPAInactiveTICLOPIDINE HYDROCHLORIDE

DMF 119681996

AARTI DRUGS LTDInactiveTICLOPIDINE HYDROCHLORIDE

DMF 223552008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 18, 2001	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 24, 1993

No patent or exclusivity listings for this strength.

#002 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 31, 1991