FDA Orange Book

Is there a generic for Onyda XR?

Onyda 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 Onyda XR (clonidine). The Orange Book shows its last listed patent expires July 28, 2041.

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Onyda XR products in the Orange Book

Onyda XR products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension, extended release, oral0.1MG/MLMarketed (Rx)None0None

NDA 217645, held by TRIS PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Onyda XR patents

Patents listed for Onyda XR
PatentExpiresCoversUse codeNDA
8062667March 29, 2029Drug productNone217645
11918689July 28, 2041Drug productU-3944217645
12576032July 28, 2041Method of useU-2357217645

Onyda XR NDC codes

Questions

Is there a generic for Onyda XR?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Onyda XR (clonidine). The Orange Book shows its last listed patent expires July 28, 2041.

What is the generic name for Onyda XR?

The active ingredient in Onyda XR is clonidine, per the FDA Orange Book.

When does the Onyda XR patent expire?

The last patent listed for Onyda XR in the Orange Book expires July 28, 2041. 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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