Gabapentin - Generic Drug Details
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What are the generic sources for gabapentin and what is the scope of patent protection?
Gabapentin
is the generic ingredient in four branded drugs marketed by ACI, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Granules, Graviti Pharms, Hikma, Invagen Pharms, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Zhejiang Yongtai, Viatris, Acella Pharms Llc, Akorn, Amneal Pharms, Belcher, Pai Holdings Pharm, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Hikma Pharms, Invatech, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Almatica, and Azurity, and is included in fifty-eight NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Gabapentin has seventy-six patent family members in forty-seven countries.
There are twenty-nine drug master file entries for gabapentin. Seventy-two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for gabapentin
International Patents: | 76 |
US Patents: | 12 |
Tradenames: | 4 |
Applicants: | 45 |
NDAs: | 58 |
Drug Master File Entries: | 29 |
Finished Product Suppliers / Packagers: | 72 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 503 |
Patent Applications: | 6,793 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
Recent Clinical Trials for gabapentin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2/Phase 3 |
Boston Medical Center | Phase 2/Phase 3 |
University of Iowa | Phase 4 |
Generic filers with tentative approvals for GABAPENTIN
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 600MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 300MG | TABLET; ORAL |
See Plans and Pricing | See Plans and Pricing | 600MG | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for gabapentin
Drug Class | Anti-epileptic Agent |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Granules | GABAPENTIN | gabapentin | CAPSULE;ORAL | 075360-003 | Apr 6, 2005 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Sun Pharm Inds Ltd | GABAPENTIN | gabapentin | CAPSULE;ORAL | 077242-002 | Aug 24, 2006 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Cspc Ouyi | GABAPENTIN | gabapentin | TABLET;ORAL | 207057-002 | Oct 26, 2017 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 gabapentin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | See Plans and Pricing | See Plans and Pricing |
Viatris | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | See Plans and Pricing | See Plans and Pricing |
Viatris | NEURONTIN | gabapentin | SOLUTION;ORAL | 021129-001 | Mar 2, 2000 | See Plans and Pricing | See Plans and Pricing |
Almatica | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for gabapentin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Guatemala | 200200089 | COMPOSICION FARMACEUTICA LIQUIDA | See Plans and Pricing |
Australia | 2002348828 | See Plans and Pricing | |
Serbia | 87203 | See Plans and Pricing | |
Iceland | 2428 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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