Tiagabine hydrochloride - Generic Drug Details
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What are the generic 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
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 5 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 89 |
| Clinical Trials: | 20 |
| Patent Applications: | 1,258 |
| 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
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 4 |
| Mid-Atlantic Epilepsy and Sleep Center, LLC | Phase 4 |
| Eisai Inc. | Phase 4 |
Pharmacology for tiagabine hydrochloride
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes 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 | 208181-002 | Dec 8, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal Pharms Co | TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 208181-001 | Dec 8, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-002 | Sep 30, 1997 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-004 | Sep 30, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-001 | Sep 30, 1997 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wilshire Pharms Inc | TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 206857-001 | Oct 13, 2017 | 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 tiagabine hydrochloride
| 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 |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-005 | Apr 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-004 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | GABITRIL | tiagabine hydrochloride | TABLET;ORAL | 020646-005 | Apr 16, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
ISSN: 2162-2639
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