FDA Orange Book
Is there a generic for Nexiclon XR?
Nexiclon XR 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 Nexiclon XR (clonidine). The Orange Book shows its last listed patent expires September 8, 2031.
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Nexiclon XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 0.17MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 0.26MG BASE | Discontinued | None | 0 | None |
NDA 022500, held by ROSEMOUNT PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nexiclon XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8337890 | April 17, 2027 | Drug product | None | 022500 |
| 8623409 | September 8, 2031 | Drug product | None | 022500 |
Nexiclon XR NDC codes
Questions
Is there a generic for Nexiclon XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nexiclon XR (clonidine). The Orange Book shows its last listed patent expires September 8, 2031.
What is the generic name for Nexiclon XR?
The active ingredient in Nexiclon XR is clonidine, per the FDA Orange Book.
When does the Nexiclon XR patent expire?
The last patent listed for Nexiclon XR in the Orange Book expires September 8, 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.
More on Nexiclon XR and Clonidine
- What is Clonidine used for?FDA label uses
- Is Clonidine a controlled substance?Federal schedule
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- Central alpha-2 Adrenergic Agonists listFDA drug class
- NDC 71511-503Nexiclon XR NDC record