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Generated: December 12, 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 Mallinckrodt Inc

International Patents:46
US Patents:13
Tradenames:28
Ingredients:19
NDAs:29
Drug Master File Entries: 138
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt IncMETHYLPHENIDATE HYDROCHLORIDEmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL203583-006Sep 29, 2015AB2RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncMORPHINE SULFATEmorphine sulfateINJECTABLE;INJECTION020631-001Jul 3, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncOXYMORPHONE HYDROCHLORIDEoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL202946-006Jun 27, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncHYDROCODONE BITARTRATE AND ACETAMINOPHENacetaminophen; hydrocodone bitartrateTABLET;ORAL206718-002Mar 31, 2017AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncMETHYLPHENIDATE HYDROCHLORIDEmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL203583-002Sep 29, 2015AB2RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncIMIPRAMINE HYDROCHLORIDEimipramine hydrochlorideTABLET;ORAL087846-003May 22, 1984ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncOXYMORPHONE HYDROCHLORIDEoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL202946-004Jun 27, 2014ABRXNoNo► Subscribe► 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 IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Mallinckrodt IncRESTORILtemazepamCAPSULE;ORAL018163-003Oct 25, 1991► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt IncPAMELORnortriptyline hydrochlorideSOLUTION;ORAL018012-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt IncEXALGOhydromorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
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Paragraph IV activity for MALLINCKRODT INC drugs

Drugname Dosage Strength Tradename Submissiondate
oxycodone hydrochloride and acetaminophenExtended-release Tablets7.5 mg/325 mgXARTEMIS XR4/3/2014

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
9,198,861Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans► Subscribe
9,629,837Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia► Subscribe
9,433,582Gastric retentive extended release pharmaceutical compositions► Subscribe
9,539,328Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
8,858,963Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration 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
Germany60101581► Subscribe
World Intellectual Property Organization (WIPO)0197783► Subscribe
South Korea101748906► Subscribe
China102105136► Subscribe
Australia2001239893► Subscribe
Russian Federation2013132138► Subscribe
TaiwanI324075► Subscribe
European Patent Office1294363► Subscribe
MexicoPA04003930► Subscribe
Australia3989301► 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/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C0021France► SubscribePRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
C/GB98/040United Kingdom► SubscribePRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
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
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
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C0041France► SubscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: 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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Serving leading biopharmaceutical companies globally:

Cipla
Argus Health
Novartis
US Department of Justice
Julphar
McKinsey
Chinese Patent Office
McKesson
Deloitte
Harvard Business School

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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