Details for New Drug Application (NDA): 022399

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NDA 022399 describes HORIZANT, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the HORIZANT profile page.

The generic ingredient in HORIZANT is gabapentin enacarbil. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gabapentin enacarbil profile page.

Summary for 022399

Tradename:	HORIZANT
Applicant:	Azurity
Ingredient:	gabapentin enacarbil
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022399

Generic Entry Date for 022399^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Pharmacology for NDA: 022399

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 022399

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	53451-0101	53451-0101-1	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)
HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	53451-0101	53451-0101-9	5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG
Approval Date:	Apr 6, 2011	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 6, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Nov 10, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Apr 11, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

Expired US Patents for NDA 022399

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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	⤷ Sign Up	⤷ Sign Up
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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