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:	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

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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	CHOLEBRINE	iocetamic acid	TABLET;ORAL	017129-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt	TRIAD	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089023-001	Jun 19, 1985		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt	FEMCET	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089102-001	Jun 19, 1985		DISCN	No	No		⤷ 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	9,050,335	⤷ Try a Trial	Y			⤷ 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	020845-002	Dec 23, 1999	5,873,359*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	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,992,218*PED	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,485,827*PED	⤷ Try a Trial
>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
2203431	CR 2015 00014	Denmark	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
0253310	SPC/GB95/010	United Kingdom	⤷ Try a Trial	PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
1713823	1490064-1	Sweden	⤷ Try a Trial	PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2932970	SPC/GB18/041	United Kingdom	⤷ Try a Trial	PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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