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 Ard	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-004	Feb 29, 2024		RX	Yes	Yes		⤷ 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	8,980,319	⤷ Try a Trial	Y			⤷ Try a Trial
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No	9,610,265*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Mallinckrodt	HIPPURAN I 131	iodohippurate sodium i-131	INJECTABLE;INJECTION	016666-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,573,209*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	7,976,870	⤷ 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	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	020845-002	Dec 23, 1999	6,125,846*PED	⤷ Try a Trial
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,028,222*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Injection	1000 mg/100 mL (10 mg/mL)	➤ Subscribe	2011-04-07

Patent Number	Expiration Date
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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	18C1043	France	⤷ Try a Trial	PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2203431	15C0013	France	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2666774	LUC00167	Luxembourg	⤷ Try a Trial	PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
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
1175904	2007C/048	Belgium	⤷ Try a Trial	PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2203431	1590018-6	Sweden	⤷ 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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Here is a list of applicants with similar names.