TIAGABINE HYDROCHLORIDE Drug Patent Profile
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When do Tiagabine Hydrochloride patents expire, and what generic alternatives are available?
Tiagabine Hydrochloride is a drug marketed by Amneal Pharms Co, MSN, Sun Pharm Inds, and Wilshire Pharms Inc. and is included in four NDAs.
The generic ingredient in TIAGABINE HYDROCHLORIDE 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 Tiagabine Hydrochloride
A generic version of TIAGABINE HYDROCHLORIDE was approved as tiagabine hydrochloride by SUN PHARM INDS on November 4th, 2011.
Summary for TIAGABINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 89 |
| Clinical Trials: | 20 |
| Patent Applications: | 855 |
| 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
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 4 |
| Eisai Inc. | Phase 4 |
| Mid-Atlantic Epilepsy and Sleep Center, LLC | 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 | 208181-001 | Dec 8, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Msn | TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 214816-003 | Nov 16, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amneal Pharms Co | TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 208181-004 | Dec 8, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Wilshire Pharms Inc | TIAGABINE HYDROCHLORIDE | tiagabine hydrochloride | TABLET;ORAL | 206857-002 | Oct 13, 2017 | 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 |
