Is there a generic for Bosentan?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Bosentan, referencing the brand TRACLEER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bosentan?

TRACLEER (NDA 209279, ACTELION) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Bosentan?

The Orange Book lists 2 patents against Bosentan products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Bosentan have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Bosentan. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Bosentan are approved?

Bosentan is approved in the following dosage forms: tablet, tablet, for suspension.

FDA Orange Book · active-ingredient family

Bosentan

Bosentan: 2 brands, 13 generics; first approved Nov 20, 2001; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 13 ANDA applications approved.

Earliest patent expiry May 15, 2026Latest exclusivity ends Feb 14, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 15, 2026

3 mo ago

Brand (NDA) products

Originator applications

TRACLEERRLDRS
ACTELIONNDA 2092792017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
32MG TABLET, FOR SUSPENSION ORAL Rx AB
TRACLEERRLD
ACTELIONNDA 02129020012 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Rx AB
125MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
32MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Rx	AB
125MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (13)

Abbreviated applications

BOSENTAN
ZYDUS PHARMSANDA 2139812026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
32MG TABLET, FOR SUSPENSION ORAL Rx AB
BOSENTAN
NATCO PHARMA LTDANDA 2131542025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
32MG TABLET, FOR SUSPENSION ORAL Rx AB
BOSENTAN
ALEMBICANDA 21146120202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
MYLANANDA 20517320202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
CHARTWELL MOLECULARANDA 21034220202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
ALVOGEN PINE BROOKANDA 20600220192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
AMNEAL PHARMS COANDA 20974220192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
HIKMAANDA 20869520192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
NATCO PHARMA LTDANDA 20698720192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
PH HEALTHANDA 20569920192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Discontinued —
125MG TABLET ORAL Discontinued —
BOSENTAN
SUN PHARMANDA 20932420192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Rx AB
125MG TABLET ORAL Rx AB
BOSENTAN
WATSON LABS INCANDA 20711020192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Rx AB
125MG TABLET ORAL Rx AB
BOSENTAN
ZYDUS PHARMSANDA 20776020192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
62.5MG TABLET ORAL Rx AB
125MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
32MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
32MG	TABLET, FOR SUSPENSION	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Discontinued	—
125MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Rx	AB
125MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Rx	AB
125MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
62.5MG	TABLET	ORAL	Rx	AB
125MG	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

PCPatent-challenge (180-day generic) exclusivity
Feb 14, 2026
6 mo ago

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8309126	May 15, 2026	3 mo ago	Product
7959945	Dec 28, 2027	in 1 yr 5 mo	Product

Approval history

FDA approval span

First approval

Nov 20, 2001

25 yr 1 mo ago

Most recent approval

Feb 17, 2026

6 mo ago

Approvals span 2001–2026 across 15 FDA applications.

Brand (NDA) 213%

Generic (ANDA) 1387%

Bosentan: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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