GABAPENTIN ENACARBIL - Generic Drug Details

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 Azurity and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gabapentin enacarbil has one hundred and forty-six 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:	146
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	28
Patent Applications:	407
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in GABAPENTIN ENACARBIL?	GABAPENTIN ENACARBIL excipients list
DailyMed Link:	GABAPENTIN ENACARBIL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GABAPENTIN ENACARBIL

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GABAPENTIN ENACARBIL

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

Sponsor	Phase
University of Texas at Austin	Phase 4
National Institute on Aging (NIA)	Phase 4
University of Missouri-Columbia	N/A

See all GABAPENTIN ENACARBIL clinical trials

Pharmacology for GABAPENTIN ENACARBIL

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	022399-001	Apr 6, 2011		RX	Yes	Yes			Y	Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y	Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes			Y	Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y	Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No

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
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011

International Patents for GABAPENTIN ENACARBIL

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2085087	Promédicaments d'analogues gaba, compositions et leurs utilisations (Prodrugs of gaba analogs, compositions and uses thereof)
China	1533270	具有降低毒性的GABA类似物前药的口服给药剂型 (Oral administered dosage form of GABA anolog prodrugs having reduced toxicity)
New Zealand	530109	Prodrugs of GABA analogs, compositions and uses thereof
Canada	2449673	FORMES DE DOSAGE DE PROMEDICAMENTS A FAIBLE TOXICITE A BASE D'ANALOGUES DU GABA, ADMINISTREES PAR VOIE ORALE (ORALLY ADMINISTERED DOSAGE FORMS OF GABA ANALOG PRODRUGS HAVING REDUCED TOXICITY)
Israel	202603	הרכב רוקחי המכיל 1 } ]איזובוטאנוילאוקסיאתוקסי) קרבוניל ]אמינומתיל{-1-ציקלוהקסן חומצה אצטית גבישית, והרכב רוקחי מקובל והשימוש שלו להכנת תרופה (Pharmaceutical composition comprising crystalline 1{[(a-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid and a pharmaceutically acceptable vehicle and use thereof for preparation of a medicament)
Japan	5856095