ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | N022501 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2015-00682 | 7704984 | IPR | Mylan Pharmaceuticals Inc. | Institution Denied | 2015-02-03 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
WARNER CHILCOTT COMPANY, LLC v. LUPIN LTD. et al 2 patentsANDA 203113norethindrone acetate and ethinyl estradiol | D.N.J. | 2011-09-01 | Terminated 2014-01-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Neuvosyn Laboratories, LLC FDA-2026-P-7276 Neuvosyn Laboratories, LLC submitted an ANDA Suitability Petition on June 29, 2026, requesting a determination that norethindrone acetate 1 mg and ethinyl estradiol 15 mcg capsules combined with ferrous fumarate 75 mg capsules are suitable for submission in an abbreviated new drug application under | Suitability | 2026-06-30 | Open | Neuvosyn Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7704984 | Feb 2, 2029 | — | — | — | — |