Gabapentin enacarbil - Generic Drug Details
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What are the generic drug 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 Azurity 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 is one drug master file entry 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: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 28 |
Patent Applications: | 599 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in gabapentin enacarbil? | gabapentin enacarbil excipients list |
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 |
University of Missouri-Columbia | 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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
HORIZANT | Extended-release Tablets | gabapentin enacarbil | 300 mg and 600 mg | 022399 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | 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 enacarbil
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | See Plans and Pricing | See Plans and Pricing |
Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 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 enacarbil
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 60223923 | See Plans and Pricing | |
Australia | 2004274002 | Treating or preventing restless legs syndrome using prodrugs of GABA analogs | See Plans and Pricing |
Israel | 159299 | See Plans and Pricing | |
Japan | 2007508396 | See Plans and Pricing | |
Japan | 2008518971 | See Plans and Pricing | |
Singapore | 147437 | CRYSTALLINE FORM OF GAMMA-AMINOBUTYRIC ACID ANALOG | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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