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Last Updated: April 18, 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 PERCHLORACAP potassium perchlorate CAPSULE;ORAL 017551-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040084-003 Jul 29, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes 8,776,794*PED ⤷  Try a Trial Y ⤷  Try a Trial
Mallinckrodt OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040550-001 Jun 30, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 8,658,631 ⤷  Try a Trial Y ⤷  Try a Trial
Mallinckrodt Ard ACTHAR GEL corticotropin INJECTABLE;INJECTION 008372-006 Approved Prior to Jan 1, 1982 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 020845-002 Dec 23, 1999 5,732,693*PED ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 5,752,504*PED ⤷  Try a Trial
Mallinckrodt Hosp UVADEX methoxsalen INJECTABLE;INJECTION 020969-001 Feb 25, 1999 4,845,075 ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 5,873,359*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 5,873,359*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

Supplementary Protection Certificates for Mallinckrodt Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0268956 SPC/GB98/040 United Kingdom ⤷  Try a Trial PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
1948158 1690020-1 Sweden ⤷  Try a Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
1856135 CR 2020 00018 Denmark ⤷  Try a Trial PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
0957929 SPC/GB06/021 United Kingdom ⤷  Try a Trial PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
2563920 CA 2019 00001 Denmark ⤷  Try a Trial PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
0480717 98C0022 France ⤷  Try a Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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