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Generated: August 23, 2017
What are the generic drug sources for gabapentin and what is the scope of gabapentin patent protection?
Gabapentin is the generic ingredient in four branded drugs marketed by Sciegen Pharms Inc, Alkem Labs Ltd, Acella Pharms Llc, Invagen Pharms, Ranbaxy, Sun Pharm Inds Ltd, Marksans Pharma, Teva Pharms Usa, Ivax Sub Teva Pharms, Sandoz, Amneal Pharms, Zydus Pharms Usa Inc, Teva, Amneal Pharms Ny, Parke Davis, Teva Pharms, Pfizer Pharms, Mylan Pharms Inc, Sun Pharm Inds, Aci Healthcare Ltd, Depomed Inc, Actavis Elizabeth, Hikma, Aurobindo Pharma Ltd, Alkem, Mylan, Apotex Inc, Taro Pharm, Glenmark Pharms Ltd, Taro, Hi Tech Pharma, Hikma Pharms, Watson Labs, Tris Pharma Inc, Epic Pharma Llc, and Arbor Pharms Llc, and is included in forty-nine NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 4 |
| Patents: | 17 |
| Applicants: | 36 |
| NDAs: | 49 |
| Drug Master File Entries: see list | 26 |
| Suppliers / Packagers: see list | 105 |
| Bulk Api Vendors: see list | 93 |
| Clinical Trials: see list | 318 |
| Patent Applications: see list | 6,038 |
| Therapeutic Class: | Anticonvulsants |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | gabapentin at DailyMed |
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 600MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 800MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 400MG | CAPSULE;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Actavis Elizabeth | GABAPENTIN | gabapentin | TABLET;ORAL | 075694-002 | Oct 21, 2004 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharm Inds | GABAPENTIN | gabapentin | CAPSULE;ORAL | 076537-002 | Jun 30, 2005 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Mylan Pharms Inc | GABAPENTIN | gabapentin | TABLET;ORAL | 090335-002 | Jun 1, 2010 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,802,157 | Methods of treatment using a gastric retained gabapentin dosage form | ► Subscribe | |||||||||||||||||||||||||||
| 8,529,955 | Methods of treatment using a gastric retained gabapentin dosage | ► Subscribe | |||||||||||||||||||||||||||
| 8,580,303 | Gastric retained gabapentin dosage form | ► Subscribe | |||||||||||||||||||||||||||
| 7,612,112 | Methods of treatment using a gastric retained gabapentin dosage | ► Subscribe | |||||||||||||||||||||||||||
| 8,592,481 | Gastric retentive gabapentin dosage forms and methods for using same | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Austria | 536863 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2013006863 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 153464 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2409999 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1294363 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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