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FDA Orange Book · active-ingredient family

Lubiprostone

Lubiprostone is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AMITIZA · NDA 021908

1

Brand (NDA)

6

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
AMITIZARLD×2SUCAMPO PHARMA LLCNDA 021908ABApr 29, 2008

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
LUBIPROSTONE×2ASCENT PHARMS INCANDA 218640ABJan 02, 2025
LUBIPROSTONE×2ZYDUS PHARMSANDA 214131ABMar 23, 2023
LUBIPROSTONE×2PH HEALTHANDA 201442—Jun 27, 2022
LUBIPROSTONE×2DR REDDYSANDA 206994ABFeb 08, 2022
LUBIPROSTONE×2TEVA PHARMS USA INCANDA 209920ABJan 18, 2022
LUBIPROSTONE×2AMNEALANDA 209450ABNov 30, 2021

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8779187Jan 23, 2027in 7 mo
Product
8338639Jan 23, 2027in 7 mo
Product
8026393Oct 25, 2027in 1 yr 4 mo
Product

Lubiprostone — frequently asked questions

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

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