FDA Orange Book
Is there a generic for Javadin?
Javadin 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 Javadin (clonidine). The Orange Book shows its last listed patent expires July 15, 2042.
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Javadin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 0.02MG/ML | Marketed (Rx) | None | 0 | None |
NDA 220256, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Javadin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12233049 | July 15, 2042 | Drug product | None | 220256 |
| 12721837 | July 15, 2042 | Drug product | None | 220256 |
| 12440474 | July 15, 2042 | Drug product | None | 220256 |
Javadin NDC codes
Questions
Is there a generic for Javadin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Javadin (clonidine). The Orange Book shows its last listed patent expires July 15, 2042.
What is the generic name for Javadin?
The active ingredient in Javadin is clonidine, per the FDA Orange Book.
When does the Javadin patent expire?
The last patent listed for Javadin in the Orange Book expires July 15, 2042. 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 Javadin 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 24338-115Javadin NDC record