FDA Orange Book
Generic for Esbriet
Esbriet contains pirfenidone. 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 Esbriet is pirfenidone. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Esbriet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 267MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 267MG | Marketed (Rx) | AB | 13 | AB |
| tablet, oral | 534MG | Discontinued | None | 2 | AB |
| tablet, oral | 801MG | Marketed (Rx) | AB | 13 | AB |
NDA 022535, 208780, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pirfenidone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 212569 | AB (A-rated, therapeutically equivalent) | January 3, 2022 | 267MG |
| ACCORD HEALTHCARE INC | 212731 | AB (A-rated, therapeutically equivalent) | January 20, 2022 | 267MG |
| ACCORD HEALTHCARE INC | 212730 | AB (A-rated, therapeutically equivalent) | January 25, 2022 | 267MG, 801MG |
| TEVA PHARMACEUTICALS USA INC | 212759 | AB (A-rated, therapeutically equivalent) | January 25, 2022 | 267MG, 801MG |
| AMNEAL EU LTD | 212570 | AB (A-rated, therapeutically equivalent) | March 25, 2022 | 267MG, 801MG |
| SANDOZ INC | 212560 | AB (A-rated, therapeutically equivalent) | April 28, 2022 | 267MG, 801MG |
| MICRO LABS LTD | 212680 | AB (A-rated, therapeutically equivalent) | May 18, 2022 | 267MG, 801MG |
| ALEMBIC PHARMACEUTICALS LTD | 212708 | AB (A-rated, therapeutically equivalent) | May 20, 2022 | 267MG, 801MG |
| MSN LABORATORIES PRIVATE LTD | 212772 | AB (A-rated, therapeutically equivalent) | May 24, 2022 | 267MG, 801MG |
| SANDOZ INC | 212600 | AB (A-rated, therapeutically equivalent) | June 13, 2022 | 267MG |
| LAURUS LABS LTD | 212724 | AB (A-rated, therapeutically equivalent) | July 19, 2022 | 267MG |
| LAURUS LABS LTD | 212722 | AB (A-rated, therapeutically equivalent) | July 19, 2022 | 267MG, 534MG, 801MG |
| AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD | 212747 | AB (A-rated, therapeutically equivalent) | July 21, 2022 | 267MG, 534MG, 801MG |
| SCIEGEN PHARMACEUTICALS INC | 212077 | AB (A-rated, therapeutically equivalent) | August 1, 2022 | 267MG |
| SCIEGEN PHARMACEUTICALS INC | 212078 | AB (A-rated, therapeutically equivalent) | August 1, 2022 | 267MG, 801MG |
| HETERO LABS LTD UNIT V | 212674 | AB (A-rated, therapeutically equivalent) | September 21, 2022 | 267MG, 801MG |
| APOTEX INC | 212709 | AB (A-rated, therapeutically equivalent) | May 31, 2023 | 267MG, 801MG |
| MACLEODS PHARMACEUTICALS LTD | 212748 | AB (A-rated, therapeutically equivalent) | December 18, 2024 | 267MG |
| AUROBINDO PHARMA LTD | 212596 | AB (A-rated, therapeutically equivalent) | August 11, 2025 | 267MG, 801MG |
| AUROBINDO PHARMA LTD | 212597 | AB (A-rated, therapeutically equivalent) | April 20, 2026 | 267MG |
Esbriet patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7988994 | September 22, 2026 | Drug product | U-1602 | 022535 |
| 7767225 | September 22, 2026 | Drug product | U-1602 | 022535 |
| 8753679 | September 22, 2026 | Drug product | U-1602 | 022535 |
| 7767700 | December 18, 2027 | Method of use | U-1601 | 022535 |
| 8420674 | December 18, 2027 | Drug product | U-1608 | 022535 |
| 7696236 | December 18, 2027 | Method of use | U-1601 | 022535 |
| 7767700 | December 18, 2027 | Method of use | U-2080 | 208780 |
| 8420674 | December 18, 2027 | Method of use | U-2079 | 208780 |
| 8383150 | May 10, 2028 | Drug product | U-2361 | 022535 |
| 8592462 | April 22, 2029 | Method of use | U-1609 | 022535 |
| 7566729 | April 22, 2029 | Method of use | U-1600 | 022535 |
| 7635707 | April 22, 2029 | Method of use | U-1609 | 022535 |
| 8609701 | April 22, 2029 | Method of use | U-1610 | 022535 |
| 7566729 | April 22, 2029 | Method of use | U-2078 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2060 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2063 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2056 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2058 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2057 | 208780 |
| 7635707 | April 22, 2029 | Method of use | U-2083 | 208780 |
| 7635707 | April 22, 2029 | Method of use | U-2074 | 208780 |
| 8609701 | April 22, 2029 | Method of use | U-2065 | 208780 |
| 8609701 | April 22, 2029 | Method of use | U-2069 | 208780 |
| 8609701 | April 22, 2029 | Method of use | U-2066 | 208780 |
| 8609701 | April 22, 2029 | Method of use | U-2067 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2059 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2061 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2055 | 208780 |
| 8609701 | April 22, 2029 | Method of use | U-2068 | 208780 |
| 8609701 | April 22, 2029 | Method of use | U-2070 | 208780 |
| 7635707 | April 22, 2029 | Method of use | U-2072 | 208780 |
| 7635707 | April 22, 2029 | Method of use | U-2075 | 208780 |
| 7566729 | April 22, 2029 | Method of use | U-2077 | 208780 |
| 7635707 | April 22, 2029 | Method of use | U-2076 | 208780 |
| 8592462 | April 22, 2029 | Method of use | U-2062 | 208780 |
| 8609701 | April 22, 2029 | Method of use | U-2064 | 208780 |
| 7635707 | April 22, 2029 | Method of use | U-2073 | 208780 |
| 7566729 | April 22, 2029 | Method of use | U-2269 | 208780 |
| 7566729 | April 22, 2029 | Method of use | U-2270 | 208780 |
| 8013002 | January 8, 2030 | Method of use | U-1603 | 022535 |
| 8318780 | January 8, 2030 | Method of use | U-1606 | 022535 |
| 7910610 | January 8, 2030 | Method of use | U-1604 | 022535 |
| 8754109 | January 8, 2030 | Method of use | U-1612 | 022535 |
| 8084475 | January 8, 2030 | Method of use | U-1605 | 022535 |
| 8648098 | January 8, 2030 | Method of use | U-1611 | 022535 |
| 7816383 | January 8, 2030 | Method of use | U-1603 | 022535 |
| 7816383 | January 8, 2030 | Method of use | U-2042 | 208780 |
| 7910610 | January 8, 2030 | Method of use | U-2049 | 208780 |
| 8318780 | January 8, 2030 | Method of use | U-2046 | 208780 |
| 8318780 | January 8, 2030 | Method of use | U-2081 | 208780 |
| 8084475 | January 8, 2030 | Method of use | U-2052 | 208780 |
| 8084475 | January 8, 2030 | Method of use | U-2054 | 208780 |
| 8648098 | January 8, 2030 | Method of use | U-2051 | 208780 |
| 8648098 | January 8, 2030 | Method of use | U-2052 | 208780 |
| 8013002 | January 8, 2030 | Method of use | U-2047 | 208780 |
| 7910610 | January 8, 2030 | Method of use | U-2048 | 208780 |
| 7816383 | January 8, 2030 | Method of use | U-2050 | 208780 |
| 8754109 | January 8, 2030 | Method of use | U-2053 | 208780 |
| 8013002 | January 8, 2030 | Method of use | U-2082 | 208780 |
| 8084475 | January 8, 2030 | Method of use | U-2268 | 208780 |
Showing 60 of 64 listed patents.
Esbriet NDC codes
Questions
Is there a generic for Esbriet?
Yes. The generic name for Esbriet is pirfenidone. 14 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 Esbriet?
The active ingredient in Esbriet is pirfenidone, per the FDA Orange Book.
When does the Esbriet patent expire?
The last patent listed for Esbriet in the Orange Book expires March 28, 2037. 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.