You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Express Scripts
Mallinckrodt
Medtronic
Moodys

Last Updated: March 8, 2021

DrugPatentWatch Database Preview

Tiagabine hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for tiagabine hydrochloride and what is the scope of patent protection?

Tiagabine hydrochloride is the generic ingredient in two branded drugs marketed by Cephalon, Amneal Pharms Co, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tiagabine hydrochloride. Four suppliers are listed for this compound.

Summary for tiagabine hydrochloride
US Patents:0
Tradenames:2
Applicants:4
NDAs:4
Drug Master File Entries: 6
Suppliers / Packagers: 4
Bulk Api Vendors: 78
Clinical Trials: 20
Patent Applications: 676
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in tiagabine hydrochloride?tiagabine hydrochloride excipients list
DailyMed Link:tiagabine hydrochloride at DailyMed
Recent Clinical Trials for tiagabine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityPhase 4
Eisai Inc.Phase 4
Mid-Atlantic Epilepsy and Sleep Center, LLCPhase 4

See all tiagabine hydrochloride clinical trials

Pharmacology for tiagabine hydrochloride
Paragraph IV (Patent) Challenges for TIAGABINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GABITRIL TABLET;ORAL tiagabine hydrochloride 020646 2014-01-24
GABITRIL TABLET;ORAL tiagabine hydrochloride 020646 2005-02-01

US Patents and Regulatory Information for tiagabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Co TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 208181-003 Dec 8, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-002 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-008 Nov 29, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tiagabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-004 Sep 30, 1997   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-002 Sep 30, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Harvard Business School
Merck
McKinsey
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.