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GABAPENTIN ENACARBIL - Generic Drug Details
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What are the generic sources for gabapentin enacarbil and what is the scope of freedom to operate?
Gabapentin enacarbil
is the generic ingredient in one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Gabapentin enacarbil has one hundred and forty-eight patent family members in twenty-six countries.
There are twenty-nine drug master file entries for gabapentin enacarbil. One supplier is listed for this compound.
Summary for GABAPENTIN ENACARBIL
| International Patents: | 148 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 28 |
| Patent Applications: | 274 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | GABAPENTIN ENACARBIL at DailyMed |
Recent Clinical Trials for GABAPENTIN ENACARBIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Aging (NIA) | Phase 4 |
| University of Texas at Austin | Phase 4 |
| The Cleveland Clinic | N/A |
Pharmacology for GABAPENTIN ENACARBIL
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for GABAPENTIN ENACARBIL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HORIZANT | TABLET, EXTENDED RELEASE;ORAL | gabapentin enacarbil | 022399 | 2019-04-29 |
US Patents and Regulatory Information for GABAPENTIN ENACARBIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arbor Pharms Llc | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Arbor Pharms Llc | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Arbor Pharms Llc | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Arbor Pharms Llc | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Arbor Pharms Llc | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Arbor Pharms Llc | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for GABAPENTIN ENACARBIL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2006112549 | Start Trial |
| South Africa | 200602722 | Start Trial |
| Japan | 2009040766 | Start Trial |
| Japan | 2007511464 | Start Trial |
| Norway | 20035474 | Start Trial |
| South Korea | 100926921 | Start Trial |
| >Country | >Patent Number | >Estimated 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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