rilpivirine hydrochloride · Janssen Prods · NDA 202022
Edurant
Earliest generic entry, as listed
15 Sep 2027
Blocked by exclusivity: PED.
FDA has approved 2 generic applications (ANDAs) for Edurant, though its earliest generic-entry date is 15 Sep 2027 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 15 Sep 2027 |
| NPP | new patient population | 15 Mar 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- First generic approved · ANDA 218798, Somerset Theraps Llc · 202022-001Approved 29 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218798, Somerset Theraps Llc · 202022-001Approved 29 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219788, Laurus · 202022-001Approved 10 Jul 2026Detected 25 Oct 2026Historical import
- Enters 12-month window basis: exclusivity · 202022-001Listed date 15 Sep 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202022 · 001 · RLD | tablet, oral | EQ 25MG BASE | 15 Sep 2027 |