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Last Updated: January 27, 2023

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

SponsorPhase
National Institute on Aging (NIA)Phase 4
University of Texas at AustinPhase 4
University of Missouri-ColumbiaN/A

See all gabapentin enacarbil clinical trials

Pharmacology for gabapentin enacarbil
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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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.