ESTRADIOL | N208564 | MAYNE PHARMA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
THERAPEUTICSMD, INC. v. TEVA PHARMACEUTICALS USA, INC. et al 8 patentsANDA 214137estradiol | D.N.J. | 2020-08-21 | Terminated 2020-09-18 | — |
THERAPEUTICSMD, INC. et al v. TEVA PHARMACEUTICALS USA, INC 7 patentsANDA 214137estradiol | D.N.J. | 2020-04-01 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Therapeutics MD, Inc. FDA-2020-P-1334 TherapeuticsMD, Inc. filed this citizen petition on May 1, 2020, requesting that the FDA refrain from approving any abbreviated new drug application referencing Imvexxy (estradiol vaginal inserts), NDA #208564, unless the generic product is manufactured qualitatively identical to Imvexxy with the sa | 505(q) | 2020-05-05 | Denied | Therapeutics MD |
Citizen Petition from TherapeuticsMD, Inc. FDA-2018-P-4714 TherapeuticsMD, Inc. filed this citizen petition under 21 CFR 10.30 and 10.31 requesting that the FDA refrain from approving any abbreviated new drug application referencing Imvexxy (estradiol vaginal inserts), NDA 208564, unless the ANDA sponsor provides bioequivalence data meeting specified requir | 505(q) | 2018-12-12 | Partially Denied | TherapeuticsMD |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9180091 | Nov 21, 2032 | — | — | Yes | — | |
| 9289382 | Nov 21, 2032 | — | — | Yes | — | — |
| 10258630 | Nov 21, 2032 | — | — | — | — | |
| 10398708 | Nov 21, 2032 | — | — | — | — | |
| 10471072 | Nov 21, 2032 | — | — | — | — | |
| 10537581 | Nov 21, 2032 | — | — | Yes | — | |
| 10568891 | Nov 21, 2032 | — | — | — | — | |
| 10668082 | Nov 21, 2032 | — | — | — | — | |
| 10806697 | Nov 21, 2032 | — | — | Yes | — | — |
| 10835487 | Nov 21, 2032 | — | — | — | — | |
| 10888516 | Nov 21, 2032 | — | — | — | — | |
| 11065197 | Nov 21, 2032 | — | — | Yes | — | — |
| 11116717 | Nov 21, 2032 | — | — | Yes | — | — |
| 11123283 | Nov 21, 2032 | — | — | Yes | — | — |
| 11241445 | Nov 21, 2032 | — | — | — | — | |
| 11246875 | Nov 21, 2032 | — | — | — | — | |
| 11266661 | Feb 2, 2034 | — | — | — | — | |
| 11304959 | Nov 21, 2032 | — | — | Yes | — | — |
| 11351182 | Nov 21, 2032 | — | — | — | — |