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Last Updated: October 29, 2020

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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 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
Recent Clinical Trials for gabapentin enacarbil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Texas at AustinPhase 4
National Institute on Aging (NIA)Phase 4
The Cleveland ClinicN/A

See all gabapentin enacarbil clinical trials

Pharmacology for gabapentin enacarbil
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 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 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 022399-002 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 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
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Mallinckrodt
Medtronic
Baxter

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