FDA Orange Book
Generic for Ofirmev
Ofirmev contains acetaminophen. 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 Ofirmev is acetaminophen. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2.
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Ofirmev products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1GM/100ML (10MG/ML) | Discontinued | None | 10 | AP1, AP2 |
NDA 022450, held by MALLINCKRODT HOSP PRODUCTS IP LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acetaminophen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 204052 | AP1 (A-rated, therapeutically equivalent) | March 22, 2016 | 1GM/100ML (10MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 202605 | AP1 (A-rated, therapeutically equivalent) | June 13, 2016 | 1GM/100ML (10MG/ML) |
| MYLAN PHARMACEUTICALS INC | 213255 | AP1 (A-rated, therapeutically equivalent) | August 7, 2020 | 1GM/100ML (10MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 210969 | AP1 (A-rated, therapeutically equivalent) | October 21, 2020 | 1GM/100ML (10MG/ML) |
| BAXTER HEALTHCARE CORP | 214331 | AP1 (A-rated, therapeutically equivalent) | September 17, 2021 | 1GM/100ML (10MG/ML) |
| ASPIRO PHARMA LTD | 216617 | AP1 (A-rated, therapeutically equivalent) | July 27, 2022 | 1GM/100ML (10MG/ML) |
| APOTEX INC | 205746 | AP1 (A-rated, therapeutically equivalent) | April 18, 2023 | 1GM/100ML (10MG/ML) |
| INFORLIFE SA | 215403 | AP1 (A-rated, therapeutically equivalent) | May 3, 2023 | 1GM/100ML (10MG/ML) |
| GLAND PHARMA LTD | 219215 | AP2 (A-rated, therapeutically equivalent) | April 2, 2025 | 1GM/100ML (10MG/ML) |
| CAPLIN STERILES LTD | 219096 | AP1 (A-rated, therapeutically equivalent) | December 5, 2025 | 1GM/100ML (10MG/ML) |
Ofirmev patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9987238 | November 13, 2028 | Method of use | U-2261 | 022450 |
| 10383834 | November 13, 2028 | Method of use | U-2262 | 022450 |
| 10383834 | November 13, 2028 | Method of use | U-2621 | 022450 |
| 9610265 | November 13, 2028 | Method of use | U-2263 | 022450 |
| 9610265*PED | May 13, 2029 | Method of use | None | 022450 |
| 9987238*PED | May 13, 2029 | Method of use | None | 022450 |
| 10383834*PED | May 13, 2029 | Method of use | None | 022450 |
| 9399012 | September 11, 2031 | Method of use | U-2262 | 022450 |
| 9399012 | September 11, 2031 | Method of use | U-2261 | 022450 |
| 9399012*PED | March 11, 2032 | Method of use | None | 022450 |
Questions
Is there a generic for Ofirmev?
Yes. The generic name for Ofirmev is acetaminophen. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2.
What is the generic name for Ofirmev?
The active ingredient in Ofirmev is acetaminophen, per the FDA Orange Book.
When does the Ofirmev patent expire?
The last patent listed for Ofirmev in the Orange Book expires March 11, 2032. 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.