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. 4 patentsANDA 213564oxycodone hydrochloride | E.D.N.C. | 2024-05-21 | Active | — |
| D. Del. | 2022-07-08 | Terminated 2024-09-09 | — | |
| D. Mass. | 2021-04-09 | Terminated 2022-05-17 | — | |
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 | — |
| D. Del. | 2018-06-07 | Terminated 2019-04-01 | — | |
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 | D. Del. | 2018-01-11 | Terminated 2019-04-01 | — |
Purdue Pharma L.P. et al v. Ascent Pharmaceuticals, Inc. 7 patentsANDA 211178oxycodone hydrochloride | E.D.N.Y. | 2018-01-11 | Terminated 2018-02-27 | — |
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 | — |
| D. Del. | 2017-09-20 | Terminated 2017-10-12 | — | |
| D. Del. | 2017-04-20 | Terminated 2017-12-28 | — | |
| D. Del. | 2017-04-07 | Terminated 2020-07-28 | — | |
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 | M.D. Fla. | 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 | Terminated 2022-05-17 | — |
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. 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. 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. 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. 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. 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. 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. 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. 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 King & Spalding FDA-2000-P-0580 · 4 docket documents King & Spalding filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner declare that abbreviated new drug applications may be submitted for combination oxycodone hydrochloride/acetaminophen tablet products in four streng | Other | 2018-08-16 | Granted | King & Spalding |
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 Hyman, Phelps & McNamara, PC on behalf of Collegium Pha... FDA-2018-P-1448 · 3 docket documents Hyman, Phelps & McNamara, PC, on behalf of Collegium Pharmaceutical, Inc., 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 for extended-release oxycodone products, including Pain Therapeutics, Inc. | 505(q) | 2018-04-09 | Open | Collegium Pharmaceutical, Inc |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2005-P-0009 · 7 docket documents Lachman Consultant Services, Inc. submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that an Abbreviated New Drug Application may be submitted for Oxycodone Hydrochloride 7.5 mg Tablets, a new dosage strength based on the | Other | 2018-01-10 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from King & Spalding FDA-1999-P-3513 · 5 docket documents King & Spalding filed this Section 505(j)(2)(C) citizen petition requesting that the FDA determine a liquid formulation containing 7.5 mg oxycodone hydrochloride and 500 mg acetaminophen per 15 mL is suitable for evaluation under an abbreviated new drug application (ANDA), based on the approved tabl | Other | 2017-07-24 | Denied | King & Spalding |
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 L.P. (Kleinfeld, Kaplan and Becker, LLP) FDA-2015-P-5108 · 16 docket documents 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, Kaplan and Becker, LLP) |
Citizen Petition from Kleinfeld Kaplan & Becker, LLP (KKB) FDA-2015-P-2120 · 10 docket documents Kleinfeld Kaplan & Becker, LLP, on behalf of Purdue Pharma L.P., filed this citizen petition under 21 C.F.R. sections 10.30, 314.50(i), 314.52, 314.54, and Section 505(b) of the Federal Food, Drug, and Cosmetic Act concerning Pfizer's Section 505(b)(2) NDA for AL0-02 (oxycodone extended-release). Pu | 505(q) | 2015-06-15 | Denied | Kleinfeld Kaplan & Becker, LLP (KKB) |
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) |
Rhodes Technologies (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition FDA-2013-P-0425 · 3 docket documents Rhodes Technologies, through counsel, filed this citizen petition pursuant to sections 355 and 701 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA maintain the current limit of not more than 10 parts per million of 14-hydroxycodeinone impurity in oxycodone hydrochloride active ph | Other | 2013-05-01 | Denied | — |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2001-P-0238 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Oxycontin (Oxycodone Hydrochloride) Extended-Release Tablets 160 mg, approved under NDA 20-553 and manufactured by Purdue Fredrick, Inc., was voluntarily withdrawn from marketing for | 505(q) | 2013-04-23 | Denied | Lachman Consultant Services, Inc. |
Lannett Company, Inc.- Citizen Petition FDA-2012-P-1180 · 4 docket documents Lannett Company, Inc. filed this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that an Abbreviated New Drug Application for Oxycodone Hydrochloride Extended-Release Capsules may be submitted and considered bioequivalent to th | Other | 2012-12-20 | Open | — |
Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker LLP) - Citizen Petition FDA-2012-P-0939 · 6 docket documents Purdue Pharma L.P. filed this citizen petition pursuant to 21 C.F.R. §§ 10.30, 314.94, 314.127, and Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA require all abbreviated new drug applications citing the reformulated OxyContin (NDA # 22-272, oxycodone hydrochloride exten | 505(q) | 2012-10-24 | Denied | — |
Pfizer Inc. (Covington & Burling LLP) - Citizen Petition FDA-2012-P-1009 · 3 docket documents Pfizer Inc., as the successor in interest to King Pharmaceuticals and sponsor of the Oxecta (oxycodone hydrochloride) NDA 20-2080, filed this citizen petition on September 21, 2012, requesting that the FDA refrain from permitting abbreviated new drug applications to rely on Oxecta as a reference lis | 505(q) | 2012-09-25 | Denied | — |
Purdue Pharma L.P., (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition FDA-2012-P-0760 · 3 docket documents Purdue Pharma L.P. filed this citizen petition under 21 C.F.R. §§ 10.30, 314.94, 314.127, Part 320, and Section 505 of the FDCA regarding abbreviated new drug applications citing reformulated OxyContin (oxycodone hydrochloride extended-release) NDA #22-272 as the Reference Listed Drug. Purdue reques | 505(q) | 2012-08-16 | Open | — |
Lannett Company, Inc. and Cody Laboratories, Inc. (Alston & Bird LLP) - Citiz... FDA-2012-P-0189 · 6 docket documents Lannett Company Inc. and its subsidiary Cody Laboratories Inc. filed this citizen petition under Sections 201 and 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA affirm the grandfather status of oxycodone hydrochloride (Lannett's Oxycodone Hydrochloride Oral Concentrate Solut | Other | 2012-03-07 | Denied | — |
Varam, Inc. - Citizen Petition FDA-2011-P-0473 · 5 docket documents Varam, Inc. filed a citizen petition regarding OxyContin, requesting that the FDA consider the company's epidemiologic study program demonstrating the effectiveness of the reformulated OxyContin in deterring abuse, with the company presenting data on its abuse-deterrent reformulation that was approv | Other | 2011-06-26 | Denied | — |
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 | — |
Sheppard, Mullin, Richter & Hampton LLP - Citizen Petition FDA-2010-P-0540 · 13 docket documents Sheppard Mullin Richter & Hampton LLP, on behalf of Purdue Pharma LP, filed this citizen petition requesting that the FDA determine that oxycodone hydrochloride extended release tablets in strengths of 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, and 80mg (NDA No. 020553) were voluntarily withdrawn for reaso | 505(q) | 2010-11-10 | Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0526 · 14 docket documents Lachman Consultant Services, Inc. filed this citizen petition pursuant to 21 CFR 10.30 and 314.161, requesting that the FDA determine whether Oxycontin (oxycodone hydrochloride) Extended-release Tablets in strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg (NDA 20-553) by Purdu | 505(q) | 2010-10-26 | Denied | — |
Troy and Alana Pack Foundation, et al - Citizen Petition FDA-2010-P-0393 · 8 docket documents The Troy and Alana Pack Foundation and affiliated organizations filed this citizen petition under 21 CFR 10.30 and 21 USC § 355 requesting that the FDA issue a public statement clarifying that there is insufficient clinical evidence to support claims that the reformulated OxyContin (controlled-relea | Other | 2010-07-26 | Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0203 · 5 docket documents Lachman Consultant Services, Inc., filed this citizen petition on behalf of an unnamed client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/500 mg, 5 m | Other | 2009-05-01 | Withdrawn | — |
Vintage Pharmaceuticals - Citizen Petition FDA-2008-P-0598 · 6 docket documents Vintage Pharmaceuticals filed this suitability petition on November 14, 2008, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Oxycodone Hydrochloride Capsules, 5 mg suitable for submission under an Abbreviated New Drug Application, with th | Other | 2008-12-02 | Withdrawn | — |
Patricia Gwen Kiser [Philip W. Thomas, P.A.] - Citizen Petition FDA-2008-P-0618 · 16 docket documents Patricia Gwen Kiser, through counsel Philip W. Thomas, P.A., filed this citizen petition requesting that the FDA revoke approval of the OxyContin label and compel Purdue Pharma to remove the misleading logarithmic scale graph from the package insert, disclose dysphoria as an adverse experience, and | 505(q) | 2008-12-02 | Partially Denied | — |
Citizen Petition from Purdue Pharma LP FDA-1999-P-2921 · 12 docket documents 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 |
Sheppard Mullin Richter & Hampton LLP - Citizen Petition FDA-2007-P-0352 · 4 docket documents On May 22, 2007, Sheppard Mullin Richter & Hampton LLP filed a citizen petition on behalf of Purdue Pharma LP requesting that the FDA determine that oxycodone hydrochloride extended release tablets in 15mg, 30mg, and 60mg strengths (NDA No. 020553) were voluntarily withdrawn for reasons other than s | 505(q) | 2008-06-10 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$32.66
per ea
Lowest NADAC/Unit
$5.88
per ea
Brand NDCs
14
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59011048010OXYCONTIN ER 80 MG TABLET | $32.66 | EA | Brand | — | 2026-06-17 |
| 59011048020OXYCONTIN ER 80 MG TABLET | $32.66 | EA | Brand | — | 2026-06-17 |
| 59011046020OXYCONTIN ER 60 MG TABLET | $26.55 | EA | Brand | — | 2026-06-17 |
| 59011046010OXYCONTIN ER 60 MG TABLET | $26.55 | EA | Brand | — | 2026-06-17 |
| 59011044020OXYCONTIN ER 40 MG TABLET | $18.77 | EA | Brand | — | 2026-06-17 |
| 59011044010OXYCONTIN ER 40 MG TABLET | $18.77 | EA | Brand | — | 2026-06-17 |
Showing 6 of 14 NDCs.
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 |
|---|---|---|---|---|---|---|
| 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 | — | — |