FDA Orange Book
Generic for Inomax
Inomax contains nitric oxide. 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 Inomax is nitric oxide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 3 Inomax products the Orange Book lists.
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Inomax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gas, inhalation | 100PPM | Discontinued | None | 0 | None |
| gas, inhalation | 4880PPM | Marketed (Rx) | None | 0 | None |
| gas, inhalation | 800PPM | Marketed (Rx) | AA | 2 | AA |
NDA 020845, held by MALLINCKRODT PHARMACEUTICALS IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nitric oxide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| VERO BIOTECH INC | 207141 | AA (A-rated, therapeutically equivalent) | October 2, 2018 | 800PPM |
| AIRGAS THERAPEUTICS LLC | 203144 | AA (A-rated, therapeutically equivalent) | July 27, 2023 | 800PPM |
Inomax patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8431163 | June 30, 2029 | Method of use | U-1286 | 020845 |
| 8795741 | June 30, 2029 | Method of use | U-1286 | 020845 |
| 8282966 | June 30, 2029 | Method of use | U-1286 | 020845 |
| 8293284 | June 30, 2029 | Method of use | U-1286 | 020845 |
| 8846112 | June 30, 2029 | Method of use | U-1286 | 020845 |
| 11931377 | June 30, 2029 | Drug substance, Drug product | U-3903 | 020845 |
| 8282966*PED | December 30, 2029 | Method of use | None | 020845 |
| 8293284*PED | December 30, 2029 | Method of use | None | 020845 |
| 8431163*PED | December 30, 2029 | Method of use | None | 020845 |
| 8795741*PED | December 30, 2029 | Method of use | None | 020845 |
| 8846112*PED | December 30, 2029 | Method of use | None | 020845 |
| 11931377*PED | December 30, 2029 | Method of use | None | 020845 |
| 8776795 | January 6, 2031 | Drug product | U-1226 | 020845 |
| 8776794 | January 6, 2031 | Drug product | U-1226 | 020845 |
| 8291904 | January 6, 2031 | Drug product | U-1226 | 020845 |
| 8573210 | January 6, 2031 | Drug product | U-1453 | 020845 |
| 8573209 | January 6, 2031 | Drug product | None | 020845 |
| 9408993 | January 6, 2031 | Drug product | U-1824 | 020845 |
| 9265911 | January 6, 2031 | Drug product | U-1824 | 020845 |
| 9295802 | January 6, 2031 | Drug product | U-1226 | 020845 |
| 8291904*PED | July 6, 2031 | Method of use | None | 020845 |
| 8776795*PED | July 6, 2031 | Method of use | None | 020845 |
| 8776794*PED | July 6, 2031 | Method of use | None | 020845 |
| 8573209*PED | July 6, 2031 | Method of use | None | 020845 |
| 8573210*PED | July 6, 2031 | Method of use | None | 020845 |
| 9295802*PED | July 6, 2031 | Method of use | None | 020845 |
| 9408993*PED | July 6, 2031 | Method of use | None | 020845 |
| 9265911*PED | July 6, 2031 | Method of use | None | 020845 |
| 9279794 | February 19, 2035 | Drug product | U-1823 | 020845 |
| 9279794*PED | August 19, 2035 | Method of use | None | 020845 |
| 9770570 | May 3, 2036 | Method of use | U-2148 | 020845 |
| 9770570*PED | November 3, 2036 | Method of use | None | 020845 |
Inomax NDC codes
Questions
Is there a generic for Inomax?
Yes. The generic name for Inomax is nitric oxide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 1 of the 3 Inomax products the Orange Book lists.
What is the generic name for Inomax?
The active ingredient in Inomax is nitric oxide, per the FDA Orange Book.
When does the Inomax patent expire?
The last patent listed for Inomax in the Orange Book expires November 3, 2036. 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.