FDA Orange Book
Generic for Rapamune
Rapamune contains sirolimus. 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 Rapamune is sirolimus. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 4 of the 5 Rapamune products the Orange Book lists.
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Rapamune products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1MG/ML | Marketed (Rx) | AA | 6 | AA |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 5MG | Discontinued | None | 0 | None |
NDA 021083, 021110, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sirolimus
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 201676 | AB (A-rated, therapeutically equivalent) | January 8, 2014 | 0.5MG, 1MG, 2MG |
| DR REDDYS LABORATORIES LTD | 201578 | AB (A-rated, therapeutically equivalent) | October 27, 2014 | 1MG, 2MG |
| NOVITIUM PHARMA LLC | 211040 | AA (A-rated, therapeutically equivalent) | January 28, 2019 | 1MG/ML |
| AMNEAL PHARMACEUTICALS LLC | 211212 | AA (A-rated, therapeutically equivalent) | October 18, 2019 | 1MG/ML |
| APOTEX INC | 211406 | AA (A-rated, therapeutically equivalent) | October 22, 2019 | 1MG/ML |
| GLENMARK PHARMACEUTICALS LTD | 208691 | AB (A-rated, therapeutically equivalent) | October 16, 2020 | 0.5MG, 1MG, 2MG |
| ALKEM LABORATORIES LTD | 214753 | AB (A-rated, therapeutically equivalent) | March 12, 2021 | 0.5MG, 1MG, 2MG |
| MSN LABORATORIES PRIVATE LTD | 216728 | AA (A-rated, therapeutically equivalent) | January 19, 2023 | 1MG/ML |
| HETERO LABS LTD UNIT V | 215080 | AA (A-rated, therapeutically equivalent) | September 16, 2024 | 1MG/ML |
| RISING PHARMA HOLDINGS INC | 215116 | AA (A-rated, therapeutically equivalent) | July 15, 2025 | 1MG/ML |
Rapamune NDC codes
Questions
Is there a generic for Rapamune?
Yes. The generic name for Rapamune is sirolimus. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 4 of the 5 Rapamune products the Orange Book lists.
What is the generic name for Rapamune?
The active ingredient in Rapamune is sirolimus, per the FDA Orange Book.
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.