FERRIC OXYHYDROXIDE | N205109 | VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Vifor Fresenius Medical Care Renal Pharma Ltd. et al v. Teva Pharmaceuticals USA, Inc. 2 patentsANDA 211411sucroferric oxyhydroxide | D. Del. | 2022-09-21 | Terminated 2023-02-06 | — |
Vifor Fresenius Medical Care Renal Pharma Ltd. et al v. Teva Pharmaceuticals USA, Inc. 3 patentsANDA 211411sucroferric oxyhydroxide | D. Del. | 2020-07-06 | Terminated 2023-02-06 | — |
Vifor Fresenius Medical Care Renal Pharma Ltd. et al v. Lupin Atlantis Holdings SA et al 1 patentANDA 211386sucroferric oxyhydroxide | D. Del. | 2020-05-26 | Terminated 2020-12-18 | — |
Vifor Fresenius Medical Care Renal Pharma Ltd. et al v. Lupin Atlantis Holdings SA et al 2 patentsANDA 211386, 211411sucroferric oxyhydroxide | D. Del. | 2018-03-12 | Terminated 2022-09-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Foley Hoag LLP on behalf of Vifor Fresenius Medical Car... FDA-2019-P-5008 Vifor Fresenius Medical Care Renal Pharma France, the NDA holder for VELPHORO (sucroferric oxyhydroxide), filed this October 25, 2019 citizen petition under 21 U.S.C. § 355 requesting that FDA establish standards for identity to determine whether proposed generic drugs with altered starches in the s | 505(q) | 2019-10-29 | Open | Foley Hoag LLP on behalf of Vifor Fresenius Medical Care Renal Pharma France |
Citizen Petition from Foley Hoag LLP (Vifor Fresenius Medical Care Renal Phar... FDA-2016-P-1163 Vifor Fresenius Medical Care Renal Pharma France, represented by Foley Hoag LLP, filed a citizen petition on April 15, 2016, requesting that the FDA grant five-year new active ingredient exclusivity to Velphoro (sucroferric oxyhydroxide) under sections 505(j)(5)(F)(ii) and 505(c)(3)(E)(ii) of the Fo | 505(q) Stay Request | 2016-04-19 | Denied | Foley Hoag LLP (Vifor Fresenius Medical Care Renal Pharma France) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9561251 | Jan 23, 2030PED: Jul 23, 2030 | PED | — | Yes | — | |
| 10624855 | Nov 26, 2034PED: May 26, 2035 | PED | — | Yes | — | — |
| 10682376 | Nov 13, 2028PED: May 13, 2029 | PED | — | Yes | — | — |
| 10695367 | Nov 13, 2028PED: May 13, 2029 | PED | — | Yes | — | — |
| 10925896 | Nov 13, 2028PED: May 13, 2029 | PED | — | Yes | — | — |
| 10925897 | Nov 13, 2028PED: May 13, 2029 | PED | — | Yes | — | — |
| 10933090 | Nov 13, 2028PED: May 13, 2029 | PED | — | Yes | — | — |
| 11013761 | Nov 13, 2028PED: May 13, 2029 | PED | — | Yes | — | — |
| 11013762 | Nov 13, 2028PED: May 13, 2029 | PED | — | Yes | — | — |
| 11234938 | Nov 26, 2034PED: May 26, 2035 | PED | — | Yes | — | — |
| 11446252 | Nov 26, 2034PED: May 26, 2035 | PED | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| NPP | Jul 1, 2027 | < 1 year |
| PED | Jan 1, 2028 | Active |