DOXYCYCLINE | N050805 | GALDERMA LABORATORIES LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-06-30 | Terminated 2023-09-05 | — | |
| D. Del. | 2022-10-05 | Terminated 2023-10-26 | — | |
| D. Del. | 2022-06-02 | Terminated 2024-03-29 | — | |
| D. Del. | 2021-12-03 | Terminated 2024-04-01 | — | |
Galderma Laboratories L.P. et al v. Amneal Pharmaceuticals LLC et al 10 patentsANDA 203278doxycycline | D. Del. | 2016-03-31 | Terminated 2018-09-04 | — |
Mylan Pharmaceuticals Inc. v. Galderma Laboratories Inc. et al 5 patentsANDA 90855doxycycline | D. Del. | 2010-10-18 | Terminated 2012-05-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Petition for Stay of Action from CollaGenex Pharmaceuticals, Inc. FDA-2002-P-0290 · 12 docket documents CollaGenex Pharmaceuticals, Inc. filed this July 2002 petition under 21 C.F.R. § 10.35 requesting a stay of action on any abbreviated new drug application (ANDA) for a generic version of Periostat (doxycycline hyclate) 20 mg capsules, which CollaGenex had voluntarily withdrawn from sale in 2001, pen | 505(q) Stay Request | 2018-03-29 | Granted | — |
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 | — |
Galderma Laboratories, L.P. (Patton Boggs, LLP) - Citizen Petition FDA-2009-P-0225 · 4 docket documents Galderma Laboratories, L.P., through counsel at Patton Boggs, LLP, filed this citizen petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA impose a 30-month stay of approval on Mylan Pharmaceuticals' pending ANDA referencing ORACEA (doxycyclin | 505(q) Stay Request | 2009-06-04 | Denied | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0341 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Doxycycline Monohydrate Tablets, 125 mg, suitable for submission in an abbreviated new drug application, using Adoxa Tabl | Other | 2009-01-08 | Open | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$29.09
per ea
Lowest NADAC/Unit
$5.85
per ea
Brand NDCs
1
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00299382230ORACEA 40 MG CAPSULE | $29.09 | EA | Brand | $5.85 | 2026-06-17 |
| 68308066830DOXYCYCLINE IR-DR 40 MG CAP | $5.85 | EA | Generic | — | 2026-06-17 |
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 |
|---|---|---|---|---|---|---|
| 7749532 | Dec 19, 2027 | — | — | Yes | — |