OXYCODONE HYDROCHLORIDE | N022272 | KNOA PHARMA LLC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2018-00625 | 9492392 | IPR | Kashiv Pharma, LLC | Terminated-Settled | 2018-02-27 | — |
| IPR2018-00717 | 9492393 | IPR | Kashiv Pharma, LLC | Terminated-Settled | 2018-02-28 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Purdue Pharma L.P. et al v. Accord Healthcare Inc. 6 patentsANDA 213564oxycodone hydrochloride | D. Del. | 2020-10-08 | Terminated 2023-04-26 | — |
Purdue Pharma L.P. et al v. Intellipharmaceutics International Inc. et al 2 patentsoxycodone hydrochloride | D. Del. | 2020-04-15 | Terminated 2020-07-28 | — |
Purdue Pharma L.P. et al v. Intellipharmaceutics International Inc. et al 10 patentsoxycodone hydrochloride | D. Del. | 2018-03-14 | Terminated 2020-07-28 | — |
Purdue Pharma L.P. et al v. Ascent Pharmaceuticals, Inc. 7 patentsANDA 211178oxycodone hydrochloride | NYED | 2018-01-11 | Terminated 2018-02-27 | — |
Purdue Pharma L.P. et al v. Ascent Pharmaceuticals, Inc. 7 patentsANDA 211178oxycodone hydrochloride | D. Del. | 2018-01-11 | Terminated 2019-04-01 | — |
Purdue Pharma L.P. et al v. Kashiv Pharma, LLC 3 patentsANDA 203235oxycodone hydrochloride | D. Del. | 2018-01-03 | Terminated 2018-08-14 | — |
Purdue Pharma L.P. et al v. Amneal Pharmaceuticals, LLC 20 patentsANDA 203235oxycodone hydrochloride | D. Del. | 2018-01-03 | Terminated 2018-08-14 | — |
Purdue Pharma L.P. et al v. Amneal Pharmaceuticals LLC 3 patentsANDA 203235oxycodone hydrochloride | D. Del. | 2017-10-10 | Terminated 2018-08-14 | — |
Purdue Pharma L.P. et al v. Amneal Pharmaceuticals, LLC 3 patentsANDA 203235oxycodone hydrochloride | D. Del. | 2017-03-01 | Terminated 2018-08-14 | — |
Purdue Pharma L.P. et al v. Abhai, LLC et al 11 patentsANDA 207493oxycodone hydrochloride | FLMD | 2016-01-21 | Terminated 2016-02-24 | — |
Purdue Pharma L.P. et al v. Abhai, LLC et al 11 patentsANDA 207493oxycodone hydrochloride | D. Del. | 2016-01-19 | Terminated 2017-12-28 | — |
Purdue Pharma L.P. et al v. Collegium Pharmaceutical, Inc. 1 patentoxycodone hydrochloride | D. Mass. | 2015-11-06 | Active | — |
Purdue Pharma L.P. et al v. Teva Pharmaceuticals USA, Inc. et al 9 patentsANDA 202455oxycodone hydrochloride | S.D.N.Y. | 2014-04-03 | Terminated 2014-12-23 | — |
Purdue Pharma L.P. et al v. Teva Pharmaceuticals USA, Inc. 2 patentsANDA 202455oxycodone hydrochloride | S.D.N.Y. | 2013-07-02 | Terminated 2014-12-23 | — |
Purdue Pharma L.P. et al v. Amneal Pharmaceuticals, LLC 1 patentANDA 203235oxycodone hydrochloride | S.D.N.Y. | 2013-05-17 | Terminated 2015-04-09 | — |
Purdue Pharma L.P. et al v. PAR Pharmaceutical, Inc. 2 patentsANDA 202434oxycodone hydrochloride | S.D.N.Y. | 2013-05-17 | Terminated 2013-09-24 | — |
Purdue Pharma L.P. et al v. Impax Laboratories, Inc. 1 patentANDA 202483oxycodone hydrochloride | S.D.N.Y. | 2013-05-10 | Terminated 2013-12-06 | — |
Purdue Pharma L.P. et al v. Watson Laboratories, Inc. et al 1 patentANDA 202352, 202372oxycodone hydrochloride extended release | S.D.N.Y. | 2013-02-04 | Terminated 2013-05-01 | — |
Purdue Pharma L.P. et al v. IMPAX Laboratories, Inc. 2 patentsANDA 202483oxycodone hydrochloride | S.D.N.Y. | 2013-02-01 | Terminated 2013-12-06 | — |
Purdue Pharma L.P. et al v. Epic Pharma, LLC 3 patentsANDA 204348oxycodone hydrochloride | S.D.N.Y. | 2013-01-30 | Terminated 2014-01-29 | — |
DEPOMED, INC. v. PURDUE PHARMA L.P. et al 3 patentsoxycodone hydrochloride controlled-release | D.N.J. | 2013-01-29 | Terminated 2018-07-09 | — |
Purdue Pharma L.P. et al v. Watson Laboratories, Inc. 1 patentANDA 202352oxycodone hydrochloride | S.D.N.Y. | 2012-04-19 | Terminated 2013-05-01 | — |
Purdue Pharma L.P. et al v. Mylan Pharmaceuticals Inc. et al 3 patentsANDA 203915oxycodone hydrochloride | S.D.N.Y. | 2012-04-13 | Terminated 2014-01-29 | — |
| S.D.N.Y. | 2012-02-03 | Terminated 2014-01-08 | — | |
Purdue Pharma L.P. et al v. Amneal Pharmaceuticals, LLC 4 patentsANDA 203235oxycodone hydrochloride | S.D.N.Y. | 2011-11-10 | Terminated 2014-01-29 | — |
| S.D.N.Y. | 2011-07-07 | Terminated 2014-01-08 | — | |
Purdue Pharma L.P. et al v. IMPAX Laboratories, Inc. 5 patentsANDA 202483oxycodone hydrochloride | S.D.N.Y. | 2011-04-08 | Terminated 2013-12-06 | — |
Purdue Pharma L.P. et al v. Ranbaxy Inc. et al 3 patentsANDA 202427oxycodone hydrochloride | S.D.N.Y. | 2011-04-08 | Terminated 2013-04-30 | — |
Purdue Pharma L.P. et al v. Teva Pharmaceuticals USA, Inc. 4 patentsANDA 202455oxycodone hydrochloride | S.D.N.Y. | 2011-03-23 | Terminated 2014-01-14 | — |
Purdue Pharma L.P. et al v. PAR Pharmaceutical, Inc. 5 patentsANDA 202434oxycodone hydrochloride | S.D.N.Y. | 2011-03-23 | Terminated 2013-09-24 | — |
Purdue Pharma L.P. et al v. Ranbaxy Inc. et al 3 patentsANDA 78093, 200455, 200692oxycodone hydrochloride | S.D.N.Y. | 2010-05-05 | Terminated 2013-07-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) FDA-2015-P-5108 Purdue Pharma L.P., through counsel, filed this citizen petition pursuant to 21 C.F.R. §§ 10.30, 314.50(i), 314.52, 314.54, and Section 505(b) of the Federal Food, Drug, and Cosmetic Act, requesting that FDA require Pfizer's 505(b)(2) NDA for AL0-02 (oxycodone extended-release tablets) to include ap | 505(q) | 2015-12-31 | Denied | Purdue Pharma L.P. (Kleinfeld |
Citizen Petition From Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) FDA-2014-P-0205 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 |
Citizen Petition from Purdue Pharma LP FDA-1999-P-2921 Purdue Pharma LP filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare the October 26, 1998 approval of Roxane Laboratories' NDA 20-932 for Roxicodone (oxycodone HCl) Sustained Release Tablets null and void, arguing that the applica | 505(q) | 2008-07-02 | Granted | Purdue Pharma LP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8808741 | Aug 24, 2027 | — | — | — | — | |
| 8894987 | Mar 29, 2030 | — | — | Yes | — | — |
| 8894988 | Aug 24, 2027 | — | — | Yes | — | — |
| 9492389 | Aug 24, 2027 | — | — | Yes | — | — |
| 9492391 | Aug 24, 2027 | — | — | — | — | |
| 9492392 | Aug 24, 2027 | — | — | Yes | — | — |
| 9492393 | Aug 24, 2027 | — | — | — | — | |
| 9763933 | Aug 24, 2027 | — | — | Yes | — | — |
| 9770416 | Aug 24, 2027 | — | — | Yes | — | — |
| 9775808 | Aug 24, 2027 | — | — | Yes | — | — |
| 11304908 | Aug 24, 2027 | — | — | Yes | — | — |
| 11304909 | Aug 24, 2027 | — | — | — | — | |
| 11964056 | Aug 24, 2027 | — | — | Yes | — | — |
| 12246094 | Aug 24, 2027 | — | — | Yes | — | — |
| 12280152 | Aug 24, 2027 | — | — | Yes | — | — |
KNOA PHARMA LLC became the applicant of record for OxyContin (oxycodone hydrochloride) NDA 022272, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
OxyContin (oxycodone hydrochloride) NDA 022272 applicant changed from Purdue Pharma LP to Knoa Pharma.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA Pharma LLC replaced Purdue Pharma LP as the applicant for OxyContin (oxycodone hydrochloride) NDA 022272.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
KNOA Pharma became the listed applicant for OxyContin (oxycodone hydrochloride) NDA 022272, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
OXYCONTIN (oxycodone hydrochloride) applicant changed from PURDUE PHARMA LP to KNOA PHARMA for NDA 022272.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA Pharma LLC became the listed applicant for OxyContin (oxycodone hydrochloride) NDA 022272, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
OxyContin (oxycodone hydrochloride) NDA 022272 applicant changed from Purdue Pharma LP to KNOA Pharma.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA Pharma acquired NDA 022272 for OxyContin (oxycodone hydrochloride) from Purdue Pharma LP, effective as the new applicant of record.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
Purdue Pharma LP transferred NDA 022272 for OxyContin (oxycodone hydrochloride) to KNOA Pharma LLC.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
KNOA Pharma became the applicant of record for OxyContin (oxycodone hydrochloride) NDA 022272, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
OxyContin (oxycodone hydrochloride) applicant changed from Purdue Pharma LP to Knoa Pharma LLC for NDA 022272.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
OxyContin (oxycodone hydrochloride) NDA 022272 applicant changed from Purdue Pharma LP to Knoa Pharma LLC.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC
KNOA PHARMA became the applicant of record for OxyContin (oxycodone hydrochloride) NDA 022272, replacing Purdue Pharma LP.
Old: PURDUE PHARMA LP
New: KNOA PHARMA
KNOA Pharma LLC acquired NDA 022272 for OxyContin (oxycodone hydrochloride) from Purdue Pharma LP, replacing the previous applicant of record.
Old: PURDUE PHARMA LP
New: KNOA PHARMA LLC