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Serving 500+ biopharmaceutical companies globally:

Merck
Fish and Richardson
Julphar
Covington
Moodys
McKesson
Daiichi Sankyo
Citi
Medtronic
Dow

Generated: July 25, 2017

DrugPatentWatch Database Preview

Mallinckrodt Company Profile

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What is the competitive landscape for MALLINCKRODT, and what generic alternatives to MALLINCKRODT drugs are available?

MALLINCKRODT has ninety-eight approved drugs.

There are thirty-five US patents protecting MALLINCKRODT drugs.

There are one hundred and twenty-five patent family members on MALLINCKRODT drugs in thirty countries.

Summary for Applicant: Mallinckrodt

Patents:35
Tradenames:74
Ingredients:51
NDAs:98
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt
TECHNECOLL
technetium tc-99m sulfur colloid kit
SOLUTION;INJECTION, ORAL017059-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
MEPERIDINE HYDROCHLORIDE
meperidine hydrochloride
TABLET;ORAL040352-001Jun 13, 2000AARXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
VASCORAY
iothalamate meglumine; iothalamate sodium
INJECTABLE;INJECTION016783-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL076412-001Jul 31, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET;ORAL040300-001Nov 27, 1998ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Mallinckrodt

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 1991► Subscribe► Subscribe
Mallinckrodt Hosp
UVADEX
methoxsalen
INJECTABLE;INJECTION020969-001Feb 25, 1999► Subscribe► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
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Paragraph IV activity for MALLINCKRODT drugs

Drugname Dosage Strength Tradename Submissiondate
nitric oxide
for Inhalation100 ppm and 800 ppm
INOMAX
5/20/2014
oxycodone hydrochloride and acetaminophen
Extended-release Tablets7.5 mg/325 mg
XARTEMIS XR
4/3/2014
acetaminophen
Injection1000 mg/100 mL (10 mg/mL)
OFIRMEV
4/7/2011
methylphenidate hydrochloride
Oral Solution5 mg/5 mL and 10 mg/5 mL
METHYLIN
4/13/2010

Non-Orange Book Patents for Mallinckrodt

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
9,629,837Pharmaceutical 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
9,433,582Gastric retentive extended release pharmaceutical compositions► Subscribe
8,790,694Gastric retentive extended release pharmaceutical compositions► Subscribe
8,858,963Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► 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 Drugs

Country Document Number Estimated Expiration
New Zealand523458► Subscribe
Portugal1294363► Subscribe
Japan4959335► Subscribe
Spain2201316► Subscribe
African Regional IP Organization (ARIPO)9801223► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0021France► SubscribePRODUCT NAME: PEGAPTANIB EN PARTICULIER SOUS FORME DE SON SEL DE SODIUM; REGISTRATION NO/DATE IN FRANCE: EU/1/05/325/001 DU 20060131; REGISTRATION NO/DATE AT EEC: EU/1/05/325/001 DU 20060131
00152Netherlands► SubscribePRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2014000065Germany► SubscribePRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
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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:

Healthtrust
McKesson
Accenture
Farmers Insurance
Mallinckrodt
Cantor Fitzgerald
US Army
McKinsey
Chubb
Cerilliant

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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