Assyro AI

FDA Orange Book · active-ingredient family

Ibuprofen lysine

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

Reference-listed drug:NEOPROFEN · NDA 021903

1

Brand (NDA)

1

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
NEOPROFENRLDRECORDATI RARENDA 021903APApr 13, 2006

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
IBUPROFEN LYSINEXGEN PHARMSANDA 202402APMar 30, 2016

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8415337Mar 02, 2032in 5 yr 9 mo
SubstanceProduct

Ibuprofen lysine — 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