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Mallinckrodt Inc Company Profile

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What is the competitive landscape for MALLINCKRODT INC, and when can generic versions of MALLINCKRODT INC drugs launch?

MALLINCKRODT INC has four approved drugs.

There are thirteen US patents protecting MALLINCKRODT INC drugs.

There are forty-six patent family members on MALLINCKRODT INC drugs in nineteen countries and thirty-one supplementary protection certificates in seven countries.

Summary for Mallinckrodt Inc

International Patents:	46
US Patents:	13
Tradenames:	4
Ingredients:	4
NDAs:	4
Drug Master File Entries:	70
Patent Litigation for Mallinckrodt Inc:	See patent lawsuits for Mallinckrodt Inc

Drugs and US Patents for Mallinckrodt Inc

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	9,468,636
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,597,681		Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,377,453		Y
Mallinckrodt Inc	METHADONE HYDROCHLORIDE	methadone hydrochloride	POWDER;FOR RX COMPOUNDING	006383-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,992,975		Y
Mallinckrodt Inc	METHADONE HYDROCHLORIDE	methadone hydrochloride	POWDER;FOR RX COMPOUNDING	006383-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,394,408		Y

Paragraph IV (Patent) Challenges for MALLINCKRODT INC drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	7.5 mg/325 mg		2014-04-03

Premature patent expirations for MALLINCKRODT INC

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

Non-Orange Book US Patents for Mallinckrodt Inc

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,629,837	Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
9,198,861	Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
8,858,963	Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
8,790,694	Gastric retentive extended release pharmaceutical compositions
9,433,582	Gastric retentive extended release pharmaceutical compositions
9,539,328	Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia

International Patents for Mallinckrodt Inc Drugs

Country	Document Number	Estimated Expiration
Canada	2822553
Japan	2015193668
Taiwan	I324075
Portugal	1294363
Japan	5897036
Spain	2213108
Australia	2011345329

Supplementary Protection Certificates for Mallinckrodt Inc Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
14/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
90018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
90062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
C/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

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 Ip
• Mallinkrodt Nuclear