DOXYCYCLINE HYCLATE | N050795 | MAYNE PHARMA INTERNATIONAL PTY LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-03-21 | Terminated 2019-09-16 | — | |
| D. Del. | 2017-11-13 | Terminated 2019-01-23 | — | |
Mayne Pharma International Pty Ltd. v. Actavis Elizabeth LLC et al 4 patentsANDA 090134doxycycline hyclate | D. Del. | 2017-11-09 | Terminated 2019-01-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Goodwin Procter LLP FDA-2017-P-5946 · 4 docket documents Goodwin Procter LLP, on behalf of an unnamed petitioner, filed this citizen petition pursuant to 21 C.F.R. §§ 10.25, 10.30, and 314.161 requesting that the FDA determine that Doryx MPC (Doxycycline Hyclate Delayed-Release Tablets), 60 mg, approved under NDA 050795 on May 20, 2016, was voluntarily wi | Other | 2017-09-27 | Granted | Goodwin Procter LLP |
Citizen Petitions from Mayne Pharma lnternational Pty Ltd FDA-2016-P-4047 · 4 docket documents Mayne Pharma International Pty Ltd filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require specific in vitro dissolution criteria for any ANDA referencing Doryx MPC (doxycycline hyclate delayed-release tablets), the company's refer | 505(q) | 2016-11-28 | Open | — |
Warner Chilcott, LLC and Mayne Pharmaceuticals International Pty Ltd. - Citiz... FDA-2011-P-0702 · 3 docket documents Warner Chilcott, LLC and Mayne Pharmaceuticals International Pty Ltd., the U.S. agent and sponsor respectively of Doryx (doxycycline hyclate delayed-release tablets) NDA 50-795, filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refra | 505(q) | 2011-09-27 | Denied | — |
Mayne Pharma International Pty Ltd and Warner Chilcott (US), LLC - Citizen Pe... FDA-2008-P-0586 · 5 docket documents Mayne Pharma International Pty Ltd and Warner Chilcott (US), LLC filed this citizen petition on November 4, 2008, requesting that the FDA confirm that doxycycline hyclate delayed-release tablets with an outer coating alone should not be considered pharmaceutically equivalent to DORYX Tablets (NDA 05 | 505(q) | 2008-11-13 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$18.18
per ea
Lowest NADAC/Unit
$3.33
per ea
Brand NDCs
1
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 51862056060DORYX MPC DR 60 MG TABLET | $18.18 | EA | Brand | — | 2025-12-17 |
| 68308071630DOXYCYCLINE HYC DR 200 MG TAB | $3.33 | EA | Generic | — | 2026-05-20 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8715724 | Feb 3, 2028 | — | — | Yes | — | — |