FDA Orange Book
Generic for Genosyl
Genosyl 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 Genosyl is nitric oxide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Genosyl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gas, inhalation | 800PPM | Marketed (Rx) | None | 2 | AA |
NDA 202860, held by VERO BIOTECH INC. 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 |
Genosyl patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8057742 | January 18, 2026 | Method of use | U-3037 | 202860 |
| 7947227 | October 17, 2026 | Method of use | U-3037 | 202860 |
| 7618594 | October 17, 2026 | Drug product | None | 202860 |
| 7560076 | April 21, 2027 | Drug product | None | 202860 |
| 9701538 | January 28, 2029 | Drug product | None | 202860 |
| 9604028 | August 13, 2029 | Method of use | U-2793 | 202860 |
| 8944049 | August 13, 2029 | Drug product | None | 202860 |
| 10926054 | August 13, 2029 | Drug product | None | 202860 |
| 11511252 | September 21, 2029 | Drug product | None | 202860 |
| 11103669 | June 21, 2030 | Drug product | None | 202860 |
| 8607785 | July 14, 2030 | Drug product | None | 202860 |
| 10737051 | October 20, 2035 | Drug product | None | 202860 |
| 10213572 | February 12, 2036 | Drug product | None | 202860 |
| 11672938 | July 22, 2040 | Method of use | U-3037 | 202860 |
Genosyl NDC codes
Questions
Is there a generic for Genosyl?
Yes. The generic name for Genosyl is nitric oxide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Genosyl?
The active ingredient in Genosyl is nitric oxide, per the FDA Orange Book.
When does the Genosyl patent expire?
The last patent listed for Genosyl in the Orange Book expires July 22, 2040. 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.