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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
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Generated: July 23, 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 thirty-one approved drugs.

There are thirteen US patents protecting MALLINCKRODT INC drugs.

There are forty-five patent family members on MALLINCKRODT INC drugs in nineteen countries.

Summary for Applicant: Mallinckrodt Inc

Patents:13
Tradenames:27
Ingredients:19
NDAs:31
Drug Master File Entries: (click here to view)137
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;ORAL204031-001Mar 11, 2014RXYesYes8,992,975► SubscribeY ► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010ABRXYesNo► Subscribe► Subscribe
Mallinckrodt Inc
METHADONE HYDROCHLORIDE
methadone hydrochloride
POWDER;FOR RX COMPOUNDING006383-004Approved Prior to Jan 1, 1982RXNoNo► Subscribe► Subscribe
Mallinckrodt Inc
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040440-001Oct 7, 2003ABRXNoNo► Subscribe► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014RXYesYes9,050,335► SubscribeY ► Subscribe
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Expired Patents for Mallinckrodt Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 19915,326,758► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 20105,914,131► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 20105,702,725► Subscribe
Mallinckrodt Inc
PAMELOR
nortriptyline hydrochloride
SOLUTION;ORAL018012-001Approved Prior to Jan 1, 19823,922,305► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 20105,914,131► 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
9,629,837Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period 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
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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
China102105136► Subscribe
World Intellectual Property Organization (WIPO)2009114648► Subscribe
World Intellectual Property Organization (WIPO)03035041► Subscribe
South Korea20140021992► Subscribe
European Patent Office2262484► 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
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
C/GB07/011United Kingdom► SubscribePRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
90018-6Sweden► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
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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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Cipla
Baxter
UBS
Deloitte
Queensland Health
Moodys
Chubb
Covington
Daiichi Sankyo

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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