Orange Book product · Generic (ANDA)
BOSENTAN
BOSENTAN
At a glance
Feb 05, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 05, 2025
1 yr 5 mo ago
Exclusivity ends · PC
Patent-challenge (180-day generic) exclusivity
Feb 14, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
BOSENTAN
Strength
32MG
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 213154
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BOSENTAN
- 2017TRACLEERBrand (NDA)
NDA 209279 · ACTELION
- 2001TRACLEERBrand (NDA)
NDA 021290 · ACTELION
- 2026BOSENTANGeneric (ANDA)
ANDA 213981 · ZYDUS PHARMS
- 2020BOSENTANGeneric (ANDA)
ANDA 211461 · ALEMBIC
- 2020BOSENTANGeneric (ANDA)
ANDA 205173 · MYLAN
- 2020BOSENTANGeneric (ANDA)
ANDA 210342 · CHARTWELL MOLECULAR
- 2019BOSENTANGeneric (ANDA)
ANDA 206002 · ALVOGEN PINE BROOK
- 2019BOSENTANGeneric (ANDA)
ANDA 209742 · AMNEAL PHARMS CO
- 2019BOSENTANGeneric (ANDA)
ANDA 208695 · HIKMA
- 2019BOSENTANGeneric (ANDA)
ANDA 206987 · NATCO PHARMA LTD
- 2019BOSENTANGeneric (ANDA)
ANDA 205699 · PH HEALTH
- 2019BOSENTANGeneric (ANDA)
ANDA 209324 · SUN PHARM
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Feb 14, 2026
4 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
