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Last Updated: December 2, 2022

Tiagabine hydrochloride - Generic Drug Details


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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, MSN, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for tiagabine hydrochloride
Recent Clinical Trials for tiagabine hydrochloride

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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 Strength NDA ANDAs Submitted Submissiondate
GABITRIL Tablets tiagabine hydrochloride 12 mg and 16 mg 020646 1 2014-01-24
GABITRIL Tablets tiagabine hydrochloride 2 mg and 4 mg 020646 1 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 208181-004 Dec 8, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 214816-003 Nov 16, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 214816-002 Nov 16, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-007 Nov 29, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms Co TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 208181-001 Dec 8, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-006 Nov 29, 2005 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 077555-002 Nov 4, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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