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Last Updated: March 29, 2024

Mallinckrodt Company Profile


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Summary for Mallinckrodt

Drugs and US Patents for Mallinckrodt

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt CONRAY 325 iothalamate sodium INJECTABLE;INJECTION 017685-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt ANEXSIA 7.5/650 acetaminophen; hydrocodone bitartrate TABLET;ORAL 089725-001 Sep 30, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt MD-60 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 087074-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 040508-001 Aug 29, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt SODIUM PHOSPHATE P 32 sodium phosphate p-32 SOLUTION;INJECTION, ORAL 011777-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt XENON XE 127 xenon xe-127 GAS;INHALATION 018536-001 Oct 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040084-001 Jun 1, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Mallinckrodt

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 5,485,827*PED ⤷  Try a Trial
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 6,028,222*PED ⤷  Try a Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 6,488,962 ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 5,732,693*PED ⤷  Try a Trial
Mallinckrodt Hosp UVADEX methoxsalen INJECTABLE;INJECTION 020969-001 Feb 25, 1999 5,036,102 ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 5,485,827*PED ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 5,558,083*PED ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for MALLINCKRODT drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 1000 mg/100 mL (10 mg/mL) ➤ Subscribe 2011-04-07
➤ Subscribe for Inhalation 100 ppm and 800 ppm ➤ Subscribe 2014-05-20
➤ Subscribe Extended-release Tablets 7.5 mg/325 mg ➤ Subscribe 2014-04-03
Premature patent expirations for MALLINCKRODT

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
⤷  Try a Trial ⤷  Try a Trial

International Patents for Mallinckrodt Drugs

Country Patent Number Estimated Expiration
Spain 2904492 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009064928 ⤷  Try a Trial
Japan 2021155433 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2015127085 ⤷  Try a Trial
China 110501462 ⤷  Try a Trial
Japan 7024013 ⤷  Try a Trial
Mexico 2013007057 ⤷  Try a Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Mallinckrodt Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 SPC/GB08/020 United Kingdom ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1718641 2012/008 Ireland ⤷  Try a Trial PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
0786264 SPC/GB08/019 United Kingdom ⤷  Try a Trial PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
1259550 08C0052 France ⤷  Try a Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
0733366 SPC/GB98/031 United Kingdom ⤷  Try a Trial PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
2822954 1890030-8 Sweden ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
2203431 2015/009 Ireland ⤷  Try a Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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