GABITRIL Drug Patent Profile
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Which patents cover Gabitril, and what generic alternatives are available?
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. Five 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.
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Summary for GABITRIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 144 |
| Clinical Trials: | 10 |
| Patent Applications: | 4,976 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-003 | Sep 30, 1997 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-007 | Nov 29, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-003 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-002 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Denmark | 288385 | ⤷ Sign Up | |
| Hungary | 9802741 | ⤷ Sign Up | |
| Poland | 323138 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |
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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.
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