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FDA Orange Book · active-ingredient family

Bosentan

Bosentan is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TRACLEER · NDA 209279

2

Brand (NDA)

13

Generics (ANDA)

2

Listed patents

1

Exclusivity periods

Brand (NDA) products · tablet, tablet, for suspension

ProductApplicantApplicationTEApproved
TRACLEERRLDACTELIONNDA 209279ABSep 05, 2017
TRACLEERRLD×2ACTELIONNDA 021290ABNov 20, 2001

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
BOSENTANZYDUS PHARMSANDA 213981ABFeb 17, 2026
BOSENTANNATCO PHARMA LTDANDA 213154ABFeb 05, 2025
BOSENTAN×2ALEMBICANDA 211461—Jan 23, 2020
BOSENTAN×2MYLANANDA 205173—Jan 15, 2020
BOSENTAN×2CHARTWELL MOLECULARANDA 210342—Jan 03, 2020
BOSENTAN×2ALVOGEN PINE BROOKANDA 206002—Apr 26, 2019
BOSENTAN×2AMNEAL PHARMS COANDA 209742—Apr 26, 2019
BOSENTAN×2HIKMAANDA 208695—Apr 26, 2019
BOSENTAN×2NATCO PHARMA LTDANDA 206987—Apr 26, 2019
BOSENTAN×2PH HEALTHANDA 205699—Apr 26, 2019
BOSENTAN×2SUN PHARMANDA 209324ABApr 26, 2019
BOSENTAN×2WATSON LABS INCANDA 207110ABApr 26, 2019
BOSENTAN×2ZYDUS PHARMSANDA 207760ABApr 26, 2019

Marketing exclusivity (1)

  • PCPatent-challenge (180-day generic) exclusivity

    Feb 14, 2026

    4 mo ago

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8309126May 15, 20261 mo ago
Product
7959945Dec 28, 2027in 1 yr 7 mo
Product

Bosentan — frequently asked questions

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

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