ACETAMINOPHEN | N022450 | MALLINCKRODT HOSP PRODUCTS IP LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Mallinckrodt Hospital Products IP Limited et al v. Baxter Healthcare Corporation 5 patentsANDA 214331acetaminophen | D. Del. | 2020-03-27 | Terminated 2020-04-30 | — |
Mallinckrodt Hospital Products IP Limited et al v. Altan Pharma Ltd. 4 patentsAcetaminophen (paracetamol) | D. Del. | 2019-03-22 | Terminated 2019-08-29 | — |
| D. Del. | 2018-07-24 | Terminated 2018-10-05 | — | |
Mallinckrodt IP Unlimited Company et al v. Aurobindo Pharma USA, Inc. 3 patentsANDA 210969acetaminophen (paracetamol) | D. Del. | 2017-12-29 | Terminated 2018-05-30 | — |
| E.D. Pa. | 2017-06-02 | Terminated 2017-10-17 | — | |
| D. Del. | 2017-05-31 | Terminated 2018-10-05 | — | |
| D. Del. | 2017-04-03 | Terminated 2018-10-05 | — | |
| N.D. Ill. | 2013-01-18 | Terminated 2013-03-12 | — | |
| S.D. Cal. | 2013-01-17 | Terminated 2014-08-08 | — | |
Cadence Pharmaceuticals, Inc. et al v. Paddock Laboratories, Inc. et al 2 patentsANDA 202605Acetaminophen | D. Minn. | 2011-08-19 | Terminated 2011-11-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Americans for Scientific Integrity FDA-2026-P-7620 · 15 docket documents Americans for Scientific Integrity filed a citizen petition under 21 C.F.R. § 10.30 requesting that the FDA require safety-related labeling changes for all acetaminophen injection products, including those approved under new drug applications and abbreviated new drug applications, to add a warning o | 505(q) | 2026-07-09 | Open | Americans for Scientific Integrity |
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2023-P-4335 · 6 docket documents The law firm Hyman, Phelps & McNamara submitted this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Acetaminophen Injection in 500 mg/50 mL and 650 mg/65 mL strengths suita | Suitability | 2023-10-05 | WithdrawnUnverified summary | HYMAN, PHELPS & MCNAMARA, P.C. |
Suitability Petition from Lachman Consultant Services, Inc. FDA-2023-P-4296 · 8 docket documents Lachman Consultant Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Acetaminophen Injection in 500 mg/50 mL and 650 mg/65 mL strengths suitable for submission in an ANDA, referencing OFIRMEV (acetaminophen) Injection 1 g/100 mL | Suitability | 2023-10-02 | Partially DeniedUnverified summary | Lachman Consultant Services, Inc. |
Citizen Petition from Nines Consult Pharma LLC FDA-2022-P-1982 · 4 docket documents Nines Consult Pharma LLC filed this citizen petition requesting that the FDA determine whether OFIRMEV (acetaminophen) injection 1000 mg/100 mL under NDA 022450, held by Mallinckrodt Hosp Products IP Ltd., was withdrawn from sale for safety or effectiveness reasons pursuant to 21 C.F.R. § 314.161. T | 505(q) | 2022-08-23 | GrantedUnverified summary | Nines Consult Pharma LLC |
Citizen Petition from B. Braun Medical Inc. FDA-2021-P-0278 · 4 docket documents B. Braun Medical Inc. filed a citizen petition requesting that the FDA assign a therapeutic equivalence rating to NDA 204957, B. Braun's Acetaminophen Injection, which was approved under section 505(b)(2) with Ofirmev as the reference listed drug. B. Braun contends that a bioequivalence study demons | Other | 2021-03-10 | DeniedUnverified summary | B. Braun Medical Inc. |
Citizen Petition from Fresenius KabiUSA, LLC FDA-2020-P-1246 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition on April 2, 2020, requesting that the FDA designate its Acetaminophen Injection 10 mg/mL, approved under 505(b)(2) NDA 204767, as therapeutically equivalent with an AP rating to the reference listed drug Ofirmev, NDA 022450, by Mallinckrodt Hosp Pr | 505(q) | 2020-04-03 | DeniedUnverified summary | Fresenius KabiUSA, LLC |
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-1071 · 6 docket documents Hyman, Phelps & McNamara, PC filed this suitability petition on behalf of a client requesting that the FDA declare Acetaminophen Injection in 500 mg/50 mL and 650 mg/65 mL strengths suitable for submission in an ANDA under Section 505(j)(2)(C) of the FDC Act, with OFIRMEV (acetaminophen) Injection 1 | Suitability | 2020-03-11 | WithdrawnUnverified summary | Hyman, Phelps & McNamara, PC |
Cadence Pharmaceuticals, Inc. (Craig Pharma Solutions LLC) - Citizen Petition FDA-2013-P-1508 · 3 docket documents Craig Pharma Solutions LLC, on behalf of Cadence Pharmaceuticals, Inc., submitted this November 2013 citizen petition requesting that the FDA refrain from approving any abbreviated new drug application or section 505(b)(2) application for an acetaminophen intravenous injection solution unless it con | 505(q) | 2013-12-13 | DeniedUnverified summary | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.