Gabapentin enacarbil - Generic Drug Details

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

See all gabapentin enacarbil clinical trials

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

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
Germany	60223923
Australia	2004274002	Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Israel	159299
Japan	2007508396
Japan	2008518971
Singapore	147437	CRYSTALLINE FORM OF GAMMA-AMINOBUTYRIC ACID ANALOG