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 Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes	10,335,452	⤷ Sign Up				⤷ Sign Up
Mallinckrodt	PERCHLORACAP	potassium perchlorate	CAPSULE;ORAL	017551-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,291,904*PED	⤷ Sign Up			Y	⤷ Sign Up
Mallinckrodt Ard	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-003	Feb 29, 2024		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Mallinckrodt	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	CAPSULE;ORAL	040257-001	Aug 4, 1998		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Mallinckrodt	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	acetaminophen; propoxyphene napsylate	TABLET;ORAL	075738-001	Feb 2, 2001		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>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	5,485,827*PED	⤷ Sign Up
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,732,693*PED	⤷ Sign Up
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	6,125,846*PED	⤷ Sign Up
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,028,222*PED	⤷ Sign Up
Mallinckrodt Hosp	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	4,999,375	⤷ Sign Up
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,873,359*PED	⤷ Sign Up
>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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	SPC/GB98/040	United Kingdom	⤷ Sign Up	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
2666774	CA 2020 00037	Denmark	⤷ Sign Up	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
2822954	18C1035	France	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0290047	97C0108	Belgium	⤷ Sign Up	PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
1758590	2017C/063	Belgium	⤷ Sign Up	PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
3347352	2290051-8	Sweden	⤷ Sign Up	PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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