FDA Orange Book
Generic for Nymalize
Nymalize contains nimodipine. 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 Nymalize is nimodipine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Nymalize products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 3MG/ML | Discontinued | None | 1 | None |
| solution, oral | 6MG/ML | Marketed (Rx) | AB | 1 | AB |
NDA 203340, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nimodipine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANNORA PHARMA PRIVATE LTD | 216937 | None (No TE code listed) | July 9, 2024 | 3MG/ML |
| ALKEM LABORATORIES LTD | 213409 | AB (A-rated, therapeutically equivalent) | January 22, 2025 | 6MG/ML |
Nymalize patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11413277 | April 16, 2038 | Drug product | U-2804 | 203340 |
| 12186308 | April 16, 2038 | Drug product | U-2804 | 203340 |
| 10342787 | April 16, 2038 | Drug product | U-2804 | 203340 |
| 10576070 | April 16, 2038 | Drug product | U-2804 | 203340 |
| 11207306 | April 16, 2038 | Method of use | U-2804 | 203340 |
| 11806338 | April 16, 2038 | Drug product | None | 203340 |
Nymalize NDC codes
Questions
Is there a generic for Nymalize?
Yes. The generic name for Nymalize is nimodipine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Nymalize?
The active ingredient in Nymalize is nimodipine, per the FDA Orange Book.
When does the Nymalize patent expire?
The last patent listed for Nymalize in the Orange Book expires April 16, 2038. 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.