ESTRADIOL | N020908 | NOVO NORDISK INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
NOVO NORDISK INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LIMITED et al 1 patentANDA 208063estradiol | D.N.J. | 2015-02-12 | Terminated 2015-07-09 | — |
| D.N.J. | 2014-07-03 | Terminated 2015-05-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Novo Nordisk - Citizen Petition FDA-2010-P-0403 · 3 docket documents Novo Nordisk Inc. filed this citizen petition on July 26, 2010, requesting that the FDA require any ANDA applicant for generic Vagifem (estradiol vaginal tablets) in 10 and 25 microgram strengths to include labeling recommending the 10 microgram dosage and to refrain from approving any generic ANDAs | 505(q) | 2010-08-02 | Withdrawn | — |
Novo Nordisk Inc. - Citizen Petition FDA-2009-P-0089 · 4 docket documents Novo Nordisk Inc. filed this citizen petition on February 18, 2009, requesting that the FDA refrain from approving any ANDA for a generic version of Vagifem (estradiol vaginal tablets) 25 micrograms unless the applicant provides data from adequate and well-controlled multiple endpoint clinical trial | 505(q) | 2009-02-20 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$20.33
per ea
Lowest NADAC/Unit
$20.33
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00169517603VAGIFEM 10 MCG VAGINAL TAB | $20.33 | EA | Brand | $6.06 | 2026-06-17 |
| 00169517604VAGIFEM 10 MCG VAGINAL TAB | $20.33 | EA | Brand | $6.06 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.