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Serving leading biopharmaceutical companies globally:

Chubb
Covington
Queensland Health
Express Scripts
Teva
US Army
Medtronic
Cantor Fitzgerald
Citi
Colorcon

Generated: October 21, 2017

DrugPatentWatch Database Preview

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 twenty-nine 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 forty supplementary protection certificates in nine countries.

Summary for Applicant: Mallinckrodt Inc

International Patents:46
US Patents:13
Tradenames:28
Ingredients:19
NDAs:29
Drug Master File Entries: (click here to view)138
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc
METHADONE HYDROCHLORIDE
methadone hydrochloride
POWDER;FOR RX COMPOUNDING006383-002Approved Prior to Jan 1, 1982RXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
METHADONE HYDROCHLORIDE
methadone hydrochloride
POWDER;FOR RX COMPOUNDING006383-004Approved Prior to Jan 1, 1982RXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
TOFRANIL-PM
imipramine pamoate
CAPSULE;ORAL017090-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL202608-001Dec 28, 2012BXRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040440-004Oct 7, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL203583-004Sep 29, 2015AB2RXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
SOLUTION;ORAL040508-001Aug 29, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
MORPHINE SULFATE
morphine sulfate
SOLUTION;ORAL202348-001Jul 15, 2011AARXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
METHYLIN ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL075629-002May 9, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Mallinckrodt Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
PAMELOR
nortriptyline hydrochloride
SOLUTION;ORAL018012-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 1991► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
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Paragraph IV activity for MALLINCKRODT INC drugs

Drugname Dosage Strength Tradename Submissiondate
oxycodone hydrochloride and acetaminophen
Extended-release Tablets7.5 mg/325 mg
XARTEMIS XR
4/3/2014

Non-Orange Book 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
9,539,328Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
9,198,861Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans► Subscribe
8,858,963Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
9,433,582Gastric retentive extended release pharmaceutical compositions► Subscribe
9,629,837Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia► Subscribe
8,790,694Gastric retentive extended release pharmaceutical compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Mallinckrodt Inc Drugs

Country Document Number Estimated Expiration
South Africa201303988► Subscribe
Australia3989301► Subscribe
Mexico2013007057► Subscribe
Australia2001239893► Subscribe
European Patent Office1439826► Subscribe
Japan2016166239► Subscribe
Japan2011513499► Subscribe
Australia2011345329► Subscribe
European Patent Office2654727► Subscribe
World Intellectual Property Organization (WIPO)03035041► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Mallinckrodt Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/036United Kingdom► SubscribePRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
C0021France► SubscribePRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
C0076France► SubscribePRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
90020-1Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
C/GB02/042United Kingdom► SubscribePRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020418
C/GB98/025United Kingdom► SubscribePRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

US Army
Deloitte
Federal Trade Commission
Chinese Patent Office
Mallinckrodt
AstraZeneca
Farmers Insurance
Citi
Medtronic
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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