FDA Orange Book
Is there a generic for QuilliChew ER?
QuilliChew ER 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for QuilliChew ER (methylphenidate). The Orange Book shows its last listed patent expires August 14, 2033.
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QuilliChew ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, chewable, oral | 20MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, chewable, oral | 30MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, chewable, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 207960, held by NEXTWAVE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
QuilliChew ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8202537 | March 15, 2027 | Drug product | None | 207960 |
| 8287903 | February 15, 2031 | Drug product | None | 207960 |
| 9295642 | August 14, 2033 | Drug product | U-1827 | 207960 |
| 11103495 | August 14, 2033 | Drug product | U-2993 | 207960 |
| 9545399 | August 14, 2033 | Drug product | U-1827 | 207960 |
| 9844544 | August 14, 2033 | Drug product | U-2203 | 207960 |
| 10857143 | August 14, 2033 | Drug product | U-2993 | 207960 |
| 11103494 | August 14, 2033 | Drug product | None | 207960 |
| 8999386 | August 14, 2033 | Drug product | None | 207960 |
| 11633389 | August 14, 2033 | Drug product | None | 207960 |
QuilliChew ER NDC codes
Questions
Is there a generic for QuilliChew ER?
No. The Orange Book lists no active FDA-approved generic (ANDA) for QuilliChew ER (methylphenidate). The Orange Book shows its last listed patent expires August 14, 2033.
What is the generic name for QuilliChew ER?
The active ingredient in QuilliChew ER is methylphenidate, per the FDA Orange Book.
When does the QuilliChew ER patent expire?
The last patent listed for QuilliChew ER in the Orange Book expires August 14, 2033. 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 QuilliChew ER and Methylphenidate
- What is QuilliChew ER used for?FDA label uses
- Is QuilliChew ER a controlled substance?Schedule II
- What is Methylphenidate used for?FDA label uses
- Is Methylphenidate a controlled substance?Schedule II
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