FDA Orange Book
Generic for Tracleer
Tracleer contains bosentan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tracleer is bosentan. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tracleer products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 32MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 125MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 62.5MG | Marketed (Rx) | AB | 3 | AB |
NDA 209279, 021290, held by ACTELION PHARMACEUTICALS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bosentan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 209324 | AB (A-rated, therapeutically equivalent) | April 26, 2019 | 125MG, 62.5MG |
| WATSON LABORATORIES INC | 207110 | AB (A-rated, therapeutically equivalent) | April 26, 2019 | 125MG, 62.5MG |
| ZYDUS PHARMACEUTICALS USA INC | 207760 | AB (A-rated, therapeutically equivalent) | April 26, 2019 | 125MG, 62.5MG |
| NATCO PHARMA LTD | 213154 | AB (A-rated, therapeutically equivalent) | February 5, 2025 | 32MG |
| ZYDUS PHARMACEUTICALS USA INC | 213981 | AB (A-rated, therapeutically equivalent) | February 17, 2026 | 32MG |
Tracleer patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8309126 | May 15, 2026 | Drug product | None | 209279 |
| 7959945 | December 28, 2027 | Drug product | None | 209279 |
Tracleer NDC codes
Questions
Is there a generic for Tracleer?
Yes. The generic name for Tracleer is bosentan. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Tracleer?
The active ingredient in Tracleer is bosentan, per the FDA Orange Book.
When does the Tracleer patent expire?
The last patent listed for Tracleer in the Orange Book expires December 28, 2027. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.