GABITRIL Drug Patent Profile
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When do Gabitril patents expire, and when can generic versions of Gabitril launch?
Gabitril is a drug marketed by Cephalon and is included in one NDA.
The generic ingredient in GABITRIL is tiagabine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gabitril
A generic version of GABITRIL was approved as tiagabine hydrochloride by SUN PHARM INDS on November 4th, 2011.
Summary for GABITRIL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 144 |
Clinical Trials: | 10 |
Patent Applications: | 4,798 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for GABITRIL |
What excipients (inactive ingredients) are in GABITRIL? | GABITRIL excipients list |
DailyMed Link: | GABITRIL at DailyMed |
Recent Clinical Trials for GABITRIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brigham and Women's Hospital | Phase 2 |
Rajesh Narendran | Phase 1 |
Cephalon | Phase 3 |
Pharmacology for GABITRIL
Drug Class | Anti-epileptic Agent |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for GABITRIL
Paragraph IV (Patent) Challenges for GABITRIL
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 GABITRIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-005 | Apr 16, 1999 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-003 | Sep 30, 1997 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-007 | Nov 29, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 GABITRIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-003 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-002 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-005 | Apr 16, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GABITRIL
See the table below for patents covering GABITRIL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 223405 | ⤷ Try a Trial | |
South Korea | 100440354 | ⤷ Try a Trial | |
Norway | 870781 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GABITRIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0236342 | 97C0107 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614 |
0236342 | SPC/GB98/022 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TIAGABINE ( INCLUDING SALTS THEREOF ); REGISTERED: FR AMM NO. 341 260.2 19960614; FR AMM NO. 341 262.5 19960614; FR AMM NO. 341 264.8 19960614; UK 03132/0117 19971111; UK 03132/0118 19971111; UK 03132/0119 19971111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |