Assyro AI

FDA Orange Book · active-ingredient family

Alvimopan

Alvimopan is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ENTEREG · NDA 021775

1

Brand (NDA)

3

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
ENTEREGRLDCUBIST PHARMSNDA 021775—May 20, 2008

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
ALVIMOPANHIKMAANDA 217753ABAug 31, 2023
ALVIMOPANPH HEALTHANDA 216843ABJan 24, 2023
ALVIMOPANWATSON LABS TEVAANDA 208295ABDec 19, 2019

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8946262Feb 12, 2030in 3 yr 8 mo
U-1655

Alvimopan — 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.

Book a Demo