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:	40
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	ANEXSIA	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040468-001	Oct 31, 2002		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
Mallinckrodt	SODIUM PERTECHNETATE TC 99M	technetium tc-99m sodium pertechnetate	SOLUTION;INJECTION, ORAL	017725-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt Ard	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-008	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,752,199	⤷ 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	ANGIO-CONRAY	iothalamate sodium	INJECTABLE;INJECTION	013319-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt	FEMCET	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089102-001	Jun 19, 1985		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

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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	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,732,693*PED	⤷ Try a Trial
Mallinckrodt Hosp	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	4,999,375	⤷ 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	5,485,827*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	6,125,846*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	2705733	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011002606	⤷ Try a Trial
Japan	7346494	⤷ Try a Trial
Australia	2012201382	⤷ Try a Trial
Australia	2017276262	⤷ Try a Trial
Mexico	2013007057	⤷ Try a Trial
European Patent Office	3978074	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	SPC/GB12/028	United Kingdom	⤷ Try a Trial	PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
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
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
2822954	LUC00083	Luxembourg	⤷ Try a Trial	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
1441735	08C0026	France	⤷ Try a Trial	PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1713823	1490064-1	Sweden	⤷ Try a Trial	PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2203431	CR 2015 00014	Denmark	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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