Mallinckrodt Company Profile

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MALLINCKRODT has forty-six approved drugs.

There are thirty-three US patents protecting MALLINCKRODT drugs.

There are one hundred and sixty-one patent family members on MALLINCKRODT drugs in twenty-two countries and seventy-eight supplementary protection certificates in eight countries.

International Patents:	161
US Patents:	33
Tradenames:	39
Ingredients:	29
NDAs:	46
Patent Litigation for Mallinckrodt:	See patent lawsuits for Mallinckrodt
PTAB Cases with Mallinckrodt as patent owner:	See PTAB cases with Mallinckrodt as patent owner

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	9,050,335	⤷ Try a Trial	Y			⤷ 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	ANEXSIA	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	089160-001	Apr 23, 1987		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes	10,335,452	⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,431,163*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 Hosp	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999		RX	Yes	Yes		⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,873,359*PED	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,732,693*PED	⤷ Try a Trial
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,992,218*PED	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	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 Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,752,504*PED	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,485,827*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

Patent Number	Expiration Date
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Country	Patent Number	Estimated Expiration
Canada	2779766	⤷ Try a Trial
Poland	3209317	⤷ Try a Trial
New Zealand	611564	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2022261102	⤷ Try a Trial
China	106055863	⤷ Try a Trial
Mexico	362813	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011002606	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	08C0052	France	⤷ Try a Trial	PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1713823	92595	Luxembourg	⤷ Try a Trial	PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
3347352	2290051-8	Sweden	⤷ Try a Trial	PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
2932970	1890039-9	Sweden	⤷ Try a Trial	PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
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
2465580	SPC/GB21/030	United Kingdom	⤷ Try a Trial	PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
2666774	CA 2020 00037	Denmark	⤷ Try a Trial	PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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