FDA Orange Book
Generic for Noxafil
Noxafil contains posaconazole. 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 Noxafil is posaconazole. 20 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
Run it in Rivvi
Map Noxafil and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Noxafil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 300MG/16.7ML (18MG/ML) | Discontinued | None | 6 | AP |
| suspension, oral | 40MG/ML | Marketed (Rx) | AB | 1 | AB |
| tablet, delayed release, oral | 100MG | Discontinued | None | 13 | AB |
NDA 205596, 022003, 205053, held by MERCK SHARP AND DOHME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic posaconazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SINOTHERAPEUTICS INC | 212411 | AB (A-rated, therapeutically equivalent) | August 21, 2019 | 100MG |
| HIKMA PHARMACEUTICALS USA INC | 208773 | AB (A-rated, therapeutically equivalent) | May 15, 2020 | 40MG/ML |
| AET PHARMA US INC | 213454 | AB (A-rated, therapeutically equivalent) | February 1, 2021 | 100MG |
| BIOCON PHARMA LTD | 214476 | AB (A-rated, therapeutically equivalent) | February 4, 2022 | 100MG |
| DR REDDYS LABORATORIES LTD | 212500 | AB (A-rated, therapeutically equivalent) | April 7, 2022 | 100MG |
| SPECGX LLC | 212226 | AB (A-rated, therapeutically equivalent) | May 10, 2022 | 100MG |
| PH HEALTH LTD | 208768 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | 300MG/16.7ML (18MG/ML) |
| HETERO LABS LTD UNIT III | 214321 | AB (A-rated, therapeutically equivalent) | December 8, 2022 | 100MG |
| AMNEAL PHARMACEUTICALS LLC | 216626 | AB (A-rated, therapeutically equivalent) | December 22, 2022 | 100MG |
| SOMERSET THERAPEUTICS LLC | 216326 | AB (A-rated, therapeutically equivalent) | June 20, 2023 | 100MG |
| PHARMAZONE | 216488 | AB (A-rated, therapeutically equivalent) | August 28, 2023 | 100MG |
| EUGIA PHARMA SPECIALITIES LTD | 214842 | AP (A-rated, therapeutically equivalent) | December 26, 2023 | 300MG/16.7ML (18MG/ML) |
| FRESENIUS KABI USA LLC | 209983 | AP (A-rated, therapeutically equivalent) | December 26, 2023 | 300MG/16.7ML (18MG/ML) |
| GLAND PHARMA LTD | 217553 | AP (A-rated, therapeutically equivalent) | December 26, 2023 | 300MG/16.7ML (18MG/ML) |
| MYLAN LABORATORIES LTD | 211500 | AP (A-rated, therapeutically equivalent) | December 26, 2023 | 300MG/16.7ML (18MG/ML) |
| AUROBINDO PHARMA LTD | 217119 | AB (A-rated, therapeutically equivalent) | July 18, 2024 | 100MG |
| ASPIRO PHARMA LTD | 219057 | AP (A-rated, therapeutically equivalent) | December 23, 2024 | 300MG/16.7ML (18MG/ML) |
| MSN LABORATORIES PRIVATE LTD | 218434 | AB (A-rated, therapeutically equivalent) | February 24, 2025 | 100MG |
| QILU PHARMACEUTICAL HAINAN CO LTD | 217720 | AB (A-rated, therapeutically equivalent) | April 23, 2025 | 100MG |
| APOTEX INC | 213331 | AB (A-rated, therapeutically equivalent) | June 29, 2026 | 100MG |
Noxafil patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9750822 | March 13, 2029 | Drug product | None | 205596 |
| 10117951 | March 13, 2029 | Drug product | None | 205596 |
| 8410077 | March 13, 2029 | Drug product | None | 205596 |
| 9358297 | June 24, 2031 | Drug product | U-3171 | 205596 |
| 9358297 | June 24, 2031 | Drug product | U-4415 | 205596 |
| 9358297 | June 24, 2031 | Drug product | U-4416 | 205596 |
| 9358297 | June 24, 2031 | Drug product | U-3160 | 205596 |
| 9023790 | July 4, 2031 | Drug product | U-3171 | 205596 |
| 9023790 | July 4, 2031 | Drug product | U-4415 | 205596 |
| 9023790 | July 4, 2031 | Drug product | U-4416 | 205596 |
| 9023790 | July 4, 2031 | Drug product | U-1698 | 205596 |
| 9023790 | July 4, 2031 | Drug product | U-3160 | 205596 |
| 9493582 | February 27, 2033 | Drug product | None | 205596 |
Noxafil exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-355 | Orphan drug exclusivity | June 17, 2028 | 205596 |
| NPP | New patient population | January 27, 2029 | 205596 |
Noxafil NDC codes
Questions
Is there a generic for Noxafil?
Yes. The generic name for Noxafil is posaconazole. 20 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Noxafil?
The active ingredient in Noxafil is posaconazole, per the FDA Orange Book.
When does the Noxafil patent expire?
The last patent listed for Noxafil in the Orange Book expires February 27, 2033. 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.