FDA Orange Book
Generic for Letairis
Letairis contains ambrisentan. 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 Letairis is ambrisentan. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Letairis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 7 | AB |
NDA 022081, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ambrisentan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 208441 | AB (A-rated, therapeutically equivalent) | March 28, 2019 | 10MG, 5MG |
| WATSON LABORATORIES INC | 208252 | AB (A-rated, therapeutically equivalent) | March 28, 2019 | 10MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 210058 | AB (A-rated, therapeutically equivalent) | March 28, 2019 | 10MG, 5MG |
| SIGMAPHARM LABORATORIES LLC | 208354 | AB (A-rated, therapeutically equivalent) | April 10, 2019 | 10MG, 5MG |
| CIPLA LTD | 210715 | AB (A-rated, therapeutically equivalent) | April 26, 2019 | 10MG, 5MG |
| APOTEX INC | 210701 | AB (A-rated, therapeutically equivalent) | May 19, 2022 | 10MG, 5MG |
| AUROBINDO PHARMA LTD | 216531 | AB (A-rated, therapeutically equivalent) | July 21, 2022 | 10MG, 5MG |
Letairis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9474752 | December 11, 2027 | Method of use | U-1754 | 022081 |
| 8377933 | December 11, 2027 | Method of use | U-1754 | 022081 |
| 9549926 | October 14, 2031 | Method of use | U-1965 | 022081 |
Letairis NDC codes
Questions
Is there a generic for Letairis?
Yes. The generic name for Letairis is ambrisentan. 7 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 Letairis?
The active ingredient in Letairis is ambrisentan, per the FDA Orange Book.
When does the Letairis patent expire?
The last patent listed for Letairis in the Orange Book expires October 14, 2031. 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.