sevelamer carbonate · Sanofi · NDA 022127, 022318
Renvela
1 of 3 marketed strengths has no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9095509.
FDA has approved 1 generic application (ANDA) for Renvela, though its earliest generic-entry date is 6 Dec 2030 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 · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9095509 | drug product · sets the listed date | 6 Dec 2030 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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
- Generic approved · ANDA 219931, Navinta Llc · 022127-001Approved 27 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022127 · 001 · RLD · discontinued | tablet, oral | 800MG | open |
| 022318 · 001 · RLD · discontinued | for suspension, oral | 800MG/PACKET | 6 Dec 2030 |
| 022318 · 002 · RLD · discontinued | for suspension, oral | 2.4GM/PACKET | 6 Dec 2030 |