FDA Orange Book
Generic for Relexxii
Relexxii contains methylphenidate. 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 Relexxii is methylphenidate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 5 of the 7 Relexxii products the Orange Book lists.
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Relexxii products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 18MG | Marketed (Rx) | None | 8 | BX, AB |
| tablet, extended release, oral | 27MG | Marketed (Rx) | None | 8 | BX, AB |
| tablet, extended release, oral | 36MG | Marketed (Rx) | None | 8 | BX, AB |
| tablet, extended release, oral | 45MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 54MG | Marketed (Rx) | None | 8 | BX, AB |
| tablet, extended release, oral | 63MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 72MG | Marketed (Rx) | None | 3 | AB |
NDA 216117, held by OSMOTICA PHARMACEUTICAL US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methylphenidate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LANNETT CO INC | 091695 | BX (B-rated, not considered equivalent) | July 9, 2013 | 18MG, 27MG, 36MG, 54MG |
| AUROLIFE PHARMA LLC | 206726 | AB (A-rated, therapeutically equivalent) | October 21, 2016 | 18MG, 27MG, 36MG, 54MG |
| OSMOTICA PHARMACEUTICAL US LLC | 205327 | AB (A-rated, therapeutically equivalent) | July 28, 2017 | 18MG, 27MG, 36MG, 54MG, 72MG |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 076655 | AB (A-rated, therapeutically equivalent) | March 21, 2018 | 54MG, 72MG |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 076772 | AB (A-rated, therapeutically equivalent) | March 22, 2018 | 18MG, 27MG, 36MG |
| ANDOR PHARMACEUTICALS LLC | 211918 | AB (A-rated, therapeutically equivalent) | April 24, 2019 | 18MG, 27MG, 36MG, 54MG |
| ASCENT PHARMACEUTICALS INC | 211009 | AB (A-rated, therapeutically equivalent) | September 3, 2019 | 18MG, 27MG, 36MG, 54MG |
| GRANULES PHARMACEUTICALS INC | 213473 | AB (A-rated, therapeutically equivalent) | July 29, 2020 | 18MG, 27MG, 36MG, 54MG |
| ALKEM LABORATORIES LTD | 214447 | AB (A-rated, therapeutically equivalent) | May 23, 2023 | 18MG, 27MG, 36MG, 54MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 217229 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 72MG |
Relexxii patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10695336 | February 3, 2037 | Method of use | U-4032 | 216117 |
| 10265308 | February 3, 2037 | Drug product | U-4032 | 216117 |
| 9855258 | February 3, 2037 | Drug product | U-4032 | 216117 |
| 9827234 | February 3, 2037 | Method of use | U-4032 | 216117 |
| 9707217 | February 3, 2037 | Drug product | None | 216117 |
Relexxii NDC codes
Questions
Is there a generic for Relexxii?
Yes. The generic name for Relexxii is methylphenidate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 5 of the 7 Relexxii products the Orange Book lists.
What is the generic name for Relexxii?
The active ingredient in Relexxii is methylphenidate, per the FDA Orange Book.
When does the Relexxii patent expire?
The last patent listed for Relexxii in the Orange Book expires February 3, 2037. 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.
More on Relexxii and Methylphenidate
- What is Relexxii used for?FDA label uses
- Is Relexxii a controlled substance?Schedule II
- What is Methylphenidate used for?FDA label uses
- Is Methylphenidate a controlled substance?Schedule II
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