FDA Orange Book
Is there a generic for Qlonilik?
Qlonilik contains clonidine. 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 Qlonilik (clonidine). The Orange Book shows its last listed patent expires August 22, 2045.
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Qlonilik products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 0.05MG/ML | Marketed (Rx) | None | 0 | None |
NDA 221094, held by CMP DEVELOPMENT LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qlonilik patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12551466 | August 22, 2045 | Drug product | U-4581 | 221094 |
Qlonilik NDC codes
Questions
Is there a generic for Qlonilik?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qlonilik (clonidine). The Orange Book shows its last listed patent expires August 22, 2045.
What is the generic name for Qlonilik?
The active ingredient in Qlonilik is clonidine, per the FDA Orange Book.
When does the Qlonilik patent expire?
The last patent listed for Qlonilik in the Orange Book expires August 22, 2045. 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.
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- NDC 46287-085Qlonilik NDC record