OXYCODONE | N208090 | COLLEGIUM PHARMACEUTICAL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-05-09 | Terminated 2020-10-07 | — | |
| D. Del. | 2018-11-30 | Terminated 2020-10-07 | — | |
Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. 12 patentsANDA 209431oxycodone | D. Del. | 2018-02-22 | Terminated 2020-10-07 | — |
Purdue Pharma L.P. et al v. Collegium Pharmaceutical, Inc. 1 patentoxycodone hydrochloride | D. Mass. | 2015-11-06 | Terminated 2022-05-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharmaceutical Manufacturing Research Services, Inc FDA-2018-P-2851 · 28 docket documents Pharmaceutical Manufacturing Research Services, Inc. filed this citizen petition on July 23, 2018, requesting that the FDA refrain from approving NDA No. 22324 for Remoxy ER, an opioid product submitted by Pain Therapeutics, Inc. under section 505(b), unless the applicant demonstrates substantial ev | 505(q) | 2018-07-24 | Denied | Pharmaceutical Manufacturing Research Services, Inc |
Citizen Petition from Dennis Ryll FDA-2017-P-5370 · 13 docket documents Dennis Ryll filed this citizen petition requesting that the FDA amend black box warnings on all Schedule II opioid analgesics (such as morphine, hydrocodone, and oxycodone) to warn prescribers and patients that Schedule III opioids like buprenorphine carry significantly lower risks of addiction and | Other | 2017-08-31 | Withdrawn | Dennis Ryll |
Citizen Petition from Hyman, Phelps & McNamara, PC (Collegium Pharmaceutical,... FDA-2016-P-1946 · 6 docket documents Collegium Pharmaceutical, Inc., through counsel Hyman, Phelps & McNamara, P.C., filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any pending NDA or supplemental NDA for extended-release oxycodone drug products unle | 505(q) | 2016-07-08 | Denied | Hyman, Phelps & McNamara, PC (Collegium Pharmaceutical, Inc. ) |
Citizen Petition From Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) FDA-2014-P-0205 · 4 docket documents Purdue Pharma LP filed this citizen petition requesting that the FDA exercise its authority under Section 505(o) of the Federal Food, Drug and Cosmetic Act to impose safety labeling changes on immediate-release opioid analgesics parallel to those mandated for extended-release and long-acting opioid | Other | 2014-02-25 | Partially Denied | Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) |
Purdue Pharma L.P. (Purdue) - Citizen petition FDA-2011-P-0045 · 6 docket documents Purdue Pharma L.P. filed this citizen petition on January 14, 2011, regarding King Pharmaceuticals' Section 505(b)(2) NDA for Remoxy (oxycodone controlled-release) Capsules, seeking to prevent approval until King includes appropriate patent certifications for the listed drug OxyContin (oxycodone hyd | 505(q) | 2011-02-08 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.