FDA Orange Book
Is there a generic for Edurant Ped?
Edurant Ped contains rilpivirine. 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 Edurant Ped (rilpivirine). The Orange Book shows its last listed patent expires October 23, 2037 and its last listed exclusivity ends September 15, 2027.
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Edurant Ped products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | EQ 2.5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219016, held by JANSSEN PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Edurant Ped patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11065198 | October 23, 2037 | Drug product | None | 219016 |
Edurant Ped exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | March 15, 2027 | 219016 |
| PED | Pediatric exclusivity | September 15, 2027 | 219016 |
Edurant Ped NDC codes
Questions
Is there a generic for Edurant Ped?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Edurant Ped (rilpivirine). The Orange Book shows its last listed patent expires October 23, 2037 and its last listed exclusivity ends September 15, 2027.
What is the generic name for Edurant Ped?
The active ingredient in Edurant Ped is rilpivirine, per the FDA Orange Book.
When does the Edurant Ped patent expire?
The last patent listed for Edurant Ped in the Orange Book expires October 23, 2037. 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.