DIENOGEST; ESTRADIOL VALERATE | N022252 | BAYER HEALTHCARE PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2017-07-27 | Terminated 2017-12-21 | — | |
Bayer Pharma AG et al v. Watson Laboratories Inc. 1 patentANDA 202349estradiol valerate and dienogest | D. Del. | 2012-12-18 | Terminated 2016-12-28 | — |
Bayer Pharma AG et al v. Lupin Ltd. et al 1 patentANDA 203307estradiol valerate and dienogest | D. Del. | 2012-11-28 | Terminated 2014-03-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Bayer HealthCare Pharmaceuticals Inc. (Ropes & Gray LLP) - Citizen Petition FDA-2013-P-0471 · 5 docket documents Bayer HealthCare Pharmaceuticals Inc., represented by Ropes & Gray LLP, filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA recognize 5-year exclusivity under sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) for dienogest, the new active mo | 505(q) | 2013-07-23 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.48
per ea
Lowest NADAC/Unit
$8.48
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50419040903NATAZIA 28 TABLET | $8.48 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.