Mallinckrodt Company Profile

What is the competitive landscape for MALLINCKRODT, and what generic alternatives to MALLINCKRODT drugs are available?

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.

Summary for Mallinckrodt

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

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	XENON XE 127	xenon xe-127	GAS;INHALATION	018536-002	Oct 1, 1982		DISCN	No	No
Mallinckrodt	ANEXSIA 7.5/650	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	089725-001	Sep 30, 1987		DISCN	No	No
Mallinckrodt	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040550-002	Jun 30, 2004		DISCN	No	No
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,573,210*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,573,209*PED				Y
Mallinckrodt	SELENOMETHIONINE SE 75	selenomethionine se-75	INJECTABLE;INJECTION	017098-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	CAPSULE;ORAL	040257-001	Aug 4, 1998		DISCN	No	No

Expired US Patents for Mallinckrodt

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	5,036,102
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,732,693*PED
Mallinckrodt Hosp	UVADEX	methoxsalen	INJECTABLE;INJECTION	020969-001	Feb 25, 1999	4,999,375
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,873,359*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	6,125,846*PED
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,028,222*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,558,083*PED

Paragraph IV (Patent) Challenges for MALLINCKRODT drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	1000 mg/100 mL (10 mg/mL)		2011-04-07
	for Inhalation	100 ppm and 800 ppm		2014-05-20
	Extended-release Tablets	7.5 mg/325 mg		2014-04-03

Premature patent expirations for MALLINCKRODT

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

International Patents for Mallinckrodt Drugs

Country	Patent Number	Estimated Expiration
Japan	2022095849
Japan	5897036
Canada	2822553
Mexico	363691
European Patent Office	2776106
World Intellectual Property Organization (WIPO)	2009114648
Canada	2939094

Supplementary Protection Certificates for Mallinckrodt Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186405	SPC/GB00/021	United Kingdom		PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2666774	LUC00167	Luxembourg		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
1856135	LUC00153	Luxembourg		PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113
1912999	14C0076	France		PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Mallard
• Mallinckrodt
• Mallinckrodt Ard
• Mallinckrodt Hosp
• Mallinckrodt Inc
• Mallinckrodt Ireland