GABAPENTIN Drug Patent Profile
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Which patents cover Gabapentin, and when can generic versions of Gabapentin launch?
Gabapentin is a drug marketed by Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Hikma, Invagen Pharms, Ipca Labs Ltd, Laurus, Marksans Pharma, Norvium Bioscience, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Acella Pharms Llc, Amneal Pharms, Annora Pharma, Belcher, Mission Pharmacal, Pai Holdings Pharm, Rubicon, Abon Pharms Llc, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Hikma Pharms, Humanwell, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms, and Zydus Pharms Usa Inc. and is included in sixty-six NDAs.
The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gabapentin
A generic version of GABAPENTIN was approved as gabapentin by ACTAVIS ELIZABETH on September 12th, 2003.
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Questions you can ask:
- What is the 5 year forecast for GABAPENTIN?
- What are the global sales for GABAPENTIN?
- What is Average Wholesale Price for GABAPENTIN?
Summary for GABAPENTIN
| US Patents: | 0 |
| Applicants: | 46 |
| NDAs: | 66 |
| Finished Product Suppliers / Packagers: | 75 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 518 |
| Patent Applications: | 4,479 |
| Drug Prices: | Drug price information for GABAPENTIN |
| Drug Sales Revenues: | Drug sales revenues for GABAPENTIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GABAPENTIN |
| What excipients (inactive ingredients) are in GABAPENTIN? | GABAPENTIN excipients list |
| DailyMed Link: | GABAPENTIN at DailyMed |
See drug prices for GABAPENTIN
Recent Clinical Trials for GABAPENTIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 3 |
| Tanta University | N/A |
| Beni-Suef University | Phase 2 |
Pharmacology for GABAPENTIN
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for GABAPENTIN
Paragraph IV (Patent) Challenges for GABAPENTIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GRALISE | Tablets | gabapentin | 300 mg and 600 mg | 022544 | 1 | 2011-10-31 |
US Patents and Regulatory Information for GABAPENTIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | GABAPENTIN | gabapentin | CAPSULE;ORAL | 077261-003 | Aug 2, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ascent Pharms Inc | GABAPENTIN | gabapentin | TABLET;ORAL | 214957-002 | Oct 1, 2021 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Norvium Bioscience | GABAPENTIN | gabapentin | CAPSULE;ORAL | 090158-002 | Feb 14, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ipca Labs Ltd | GABAPENTIN | gabapentin | CAPSULE;ORAL | 208928-002 | Nov 20, 2023 | AB | RX | 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 |
