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FDA Orange Book · active-ingredient family

Gabapentin enacarbil

Gabapentin enacarbil is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:HORIZANT · NDA 022399

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, extended release

ProductApplicantApplicationTEApproved
HORIZANTRLD×2AZURITYNDA 022399—Dec 13, 2011

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8114909Apr 11, 20262 mo ago
U-1231
8026279Nov 10, 2026in 5 mo
SubstanceProduct
8795725Jun 10, 2029in 3 yr
ProductU-1231

Gabapentin enacarbil — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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