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 Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,282,966*PED				Y
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes	10,335,452
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,795,741*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,573,209*PED				Y
Mallinckrodt Inc	METHADONE HYDROCHLORIDE	methadone hydrochloride	POWDER;FOR RX COMPOUNDING	006383-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt	VASCORAY	iothalamate meglumine; iothalamate sodium	INJECTABLE;INJECTION	016783-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt	SELENOMETHIONINE SE 75	selenomethionine se-75	INJECTABLE;INJECTION	017098-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Mallinckrodt

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
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,732,693*PED
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,992,218*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,485,827*PED
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,028,222*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,752,504*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,485,827*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
China	106055863
Hong Kong	1152469
Australia	2022201219
New Zealand	707513
Portugal	2968824
Canada	3114977
Australia	2011345329

Supplementary Protection Certificates for Mallinckrodt Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
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
0268956	SPC/GB98/040	United Kingdom		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
1856135	CR 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113

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