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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
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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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