FDA Orange Book
Generic for Cotempla XR-ODT
Cotempla XR-ODT 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 Cotempla XR-ODT is methylphenidate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Cotempla XR-ODT products the Orange Book lists.
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Cotempla XR-ODT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, extended release, oral | 17.3MG | Marketed (Rx) | AB | 1 | AB |
| tablet, orally disintegrating, extended release, oral | 25.9MG | Marketed (Rx) | AB | 1 | AB |
| tablet, orally disintegrating, extended release, oral | 34.6MG | Discontinued | None | 0 | None |
| tablet, orally disintegrating, extended release, oral | 8.6MG | Marketed (Rx) | AB | 1 | AB |
NDA 205489, held by NEOS THERAPEUTICS INC. 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 |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 210924 | AB (A-rated, therapeutically equivalent) | June 19, 2020 | 17.3MG, 25.9MG, 8.6MG |
Cotempla XR-ODT patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8840924 | June 5, 2026 | Drug product | None | 205489 |
| 9089496 | June 28, 2032 | Drug product | None | 205489 |
| 9072680 | June 28, 2032 | Drug product | None | 205489 |
| 11166947 | January 25, 2038 | Method of use | U-3299 | 205489 |
Cotempla XR-ODT NDC codes
Questions
Is there a generic for Cotempla XR-ODT?
Yes. The generic name for Cotempla XR-ODT is methylphenidate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Cotempla XR-ODT products the Orange Book lists.
What is the generic name for Cotempla XR-ODT?
The active ingredient in Cotempla XR-ODT is methylphenidate, per the FDA Orange Book.
When does the Cotempla XR-ODT patent expire?
The last patent listed for Cotempla XR-ODT in the Orange Book expires January 25, 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.
More on Cotempla XR-ODT and Methylphenidate
- What is Cotempla XR-ODT used for?FDA label uses
- Is Cotempla XR-ODT a controlled substance?Schedule II
- What is Methylphenidate used for?FDA label uses
- Is Methylphenidate a controlled substance?Schedule II
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