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FDA Orange Book · active-ingredient family

Ambrisentan

Ambrisentan is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LETAIRIS · NDA 022081

1

Brand (NDA)

9

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
LETAIRISRLD×2GILEADNDA 022081ABJun 15, 2007

Generic (ANDA) products (9)

ProductApplicantApplicationTEApproved
AMBRISENTAN×2AUROBINDO PHARMAANDA 216531ABJul 21, 2022
AMBRISENTAN×2APOTEXANDA 210701ABMay 19, 2022
AMBRISENTAN×2CIPLAANDA 210715ABApr 26, 2019
AMBRISENTAN×2PH HEALTHANDA 209509—Apr 10, 2019
AMBRISENTAN×2SIGMAPHARM LABS LLCANDA 208354ABApr 10, 2019
AMBRISENTAN×2MYLANANDA 208441ABMar 28, 2019
AMBRISENTAN×2SUN PHARMANDA 210784—Mar 28, 2019
AMBRISENTAN×2WATSON LABS INCANDA 208252ABMar 28, 2019
AMBRISENTAN×2ZYDUS PHARMSANDA 210058ABMar 28, 2019

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9474752Dec 11, 2027in 1 yr 6 mo
U-1754
8377933Dec 11, 2027in 1 yr 6 mo
U-1754
9549926Oct 14, 2031in 5 yr 5 mo
U-1965

Ambrisentan — frequently asked questions

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

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