FDA Orange Book
Generic for Quillivant XR
Quillivant XR 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 Quillivant XR is methylphenidate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Quillivant XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, extended release, oral | 5MG/ML | Marketed (Rx) | AB | 1 | AB |
NDA 202100, held by NEXTWAVE PHARMACEUTICALS INC A SUB OF TRIS PHARMA 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 LABORATORIES FL INC | 206049 | AB (A-rated, therapeutically equivalent) | May 17, 2018 | 5MG/ML |
Quillivant XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8062667 | March 29, 2029 | Drug product | None | 202100 |
| 8465765 | February 15, 2031 | Drug product | U-1415 | 202100 |
| 8778390 | February 15, 2031 | Drug product | U-1543 | 202100 |
| 8956649 | February 15, 2031 | Drug product | U-1665 | 202100 |
| 8563033 | February 15, 2031 | Drug product | U-1415 | 202100 |
| 9040083 | February 15, 2031 | Drug product | None | 202100 |
| 8287903 | February 15, 2031 | Drug product | None | 202100 |
Quillivant XR NDC codes
Questions
Is there a generic for Quillivant XR?
Yes. The generic name for Quillivant XR is methylphenidate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Quillivant XR?
The active ingredient in Quillivant XR is methylphenidate, per the FDA Orange Book.
When does the Quillivant XR patent expire?
The last patent listed for Quillivant XR in the Orange Book expires February 15, 2031. 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.