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FDA Orange Book · active-ingredient family

Famotidine; ibuprofen

Famotidine; ibuprofen is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DUEXIS · NDA 022519

1

Brand (NDA)

7

Generics (ANDA)

5

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
DUEXISRLDHORIZONNDA 022519—Apr 23, 2011

Generic (ANDA) products (7)

ProductApplicantApplicationTEApproved
IBUPROFEN AND FAMOTIDINEAUROBINDO PHARMA LTDANDA 219538—Jun 30, 2025
IBUPROFEN AND FAMOTIDINEZYDUS LIFESCIENCESANDA 218684ABFeb 20, 2025
IBUPROFEN AND FAMOTIDINEPH HEALTHANDA 203658ABMar 22, 2024
IBUPROFEN AND FAMOTIDINETORRENTANDA 215925—Mar 18, 2024
IBUPROFEN AND FAMOTIDINEASCENT PHARMS INCANDA 216814ABMar 15, 2023
IBUPROFEN AND FAMOTIDINETEVA PHARMS USAANDA 211278—Oct 29, 2021
IBUPROFEN AND FAMOTIDINEALKEM LABS LTDANDA 211890ABAug 03, 2021

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8067451Jul 18, 2026in 29 d
ProductU-1196
8501228Jul 18, 2026in 29 d
U-1196
8318202Jul 18, 2026in 29 d
Product
8309127Jul 18, 2026in 29 d
Product
8449910Jul 18, 2026in 29 d
Product

Famotidine; ibuprofen — frequently asked questions

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

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