FDA Orange Book
Generic for Namenda XR
Namenda XR contains memantine. 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 Namenda XR is memantine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Namenda XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 14MG | Discontinued | None | 8 | AB |
| capsule, extended release, oral | 21MG | Discontinued | None | 8 | AB |
| capsule, extended release, oral | 28MG | Discontinued | None | 8 | AB |
| capsule, extended release, oral | 7MG | Discontinued | None | 8 | AB |
NDA 022525, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic memantine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 206028 | AB (A-rated, therapeutically equivalent) | September 28, 2016 | 14MG, 21MG, 28MG, 7MG |
| RISING PHARMA HOLDING INC | 206032 | AB (A-rated, therapeutically equivalent) | September 28, 2016 | 14MG, 21MG, 28MG, 7MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 205825 | AB (A-rated, therapeutically equivalent) | October 12, 2016 | 14MG, 21MG, 28MG, 7MG |
| ZYDUS PHARMACEUTICALS USA INC | 203293 | AB (A-rated, therapeutically equivalent) | August 3, 2017 | 14MG, 21MG, 28MG, 7MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 211100 | AB (A-rated, therapeutically equivalent) | April 2, 2021 | 14MG, 21MG, 28MG, 7MG |
| AUROBINDO PHARMA LTD | 214651 | AB (A-rated, therapeutically equivalent) | August 9, 2021 | 14MG, 21MG, 28MG, 7MG |
| H2-PHARMA LLC | 213985 | AB (A-rated, therapeutically equivalent) | October 11, 2022 | 14MG, 21MG, 28MG, 7MG |
| MACLEODS PHARMACEUTICALS LTD | 206310 | AB (A-rated, therapeutically equivalent) | August 28, 2025 | 14MG, 21MG, 28MG, 7MG |
Namenda XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8039009 | March 24, 2029 | Method of use | U-539 | 022525 |
| 8039009*PED | September 24, 2029 | Method of use | None | 022525 |
Questions
Is there a generic for Namenda XR?
Yes. The generic name for Namenda XR is memantine. 8 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 Namenda XR?
The active ingredient in Namenda XR is memantine, per the FDA Orange Book.
When does the Namenda XR patent expire?
The last patent listed for Namenda XR in the Orange Book expires September 24, 2029. 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.