FDA Orange Book
Generic for Skelaxin
Skelaxin contains metaxalone. 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 Skelaxin is metaxalone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Skelaxin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 400MG | Discontinued | None | 2 | AB |
| tablet, oral | 800MG | Discontinued | None | 5 | AB |
NDA 013217, held by KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC A SUB OF PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metaxalone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 040445 | AB (A-rated, therapeutically equivalent) | March 31, 2010 | 800MG |
| AMNEAL PHARMACEUTICALS | 203399 | AB (A-rated, therapeutically equivalent) | June 21, 2013 | 800MG |
| MOUNTAIN LLC | 040486 | AB (A-rated, therapeutically equivalent) | February 27, 2015 | 400MG |
| LANNETT CO INC | 204770 | AB (A-rated, therapeutically equivalent) | November 22, 2016 | 800MG |
| ACTAVIS LABORATORIES FL INC | 203695 | AB (A-rated, therapeutically equivalent) | June 15, 2017 | 800MG |
| SCIEGEN PHARMACEUTICALS INC | 207466 | AB (A-rated, therapeutically equivalent) | March 13, 2020 | 400MG, 800MG |
Skelaxin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7122566 | February 6, 2026 | Method of use | U-915 | 013217 |
Questions
Is there a generic for Skelaxin?
Yes. The generic name for Skelaxin is metaxalone. 6 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 Skelaxin?
The active ingredient in Skelaxin is metaxalone, per the FDA Orange Book.
When does the Skelaxin patent expire?
The last patent listed for Skelaxin in the Orange Book expires February 6, 2026. 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.