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Serving 500+ biopharmaceutical companies globally:

Dow
Colorcon
Chubb
Chinese Patent Office
Medtronic
Cerilliant
Fuji
Mallinckrodt
Daiichi Sankyo
Queensland Health

Generated: September 19, 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-six approved drugs.

There are thirty-five US patents protecting MALLINCKRODT drugs.

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

Summary for Applicant: Mallinckrodt

Patents:35
Tradenames:75
Ingredients:51
NDAs:96
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Ip
OFIRMEV
acetaminophen
SOLUTION;IV (INFUSION)022450-001Nov 2, 2010APRXYesYes► Subscribe► SubscribeY► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Mallinckrodt
CHOLEBRINE
iocetamic acid
TABLET;ORAL017129-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL076758-001Jun 30, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
TOFRANIL-PM
imipramine pamoate
CAPSULE;ORAL017090-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999DISCNYesNo► Subscribe► SubscribeY► Subscribe
Mallinckrodt
FENTANYL CITRATE
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL078907-001Oct 30, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL202608-003Dec 28, 2012BXRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
LORCET-HD
acetaminophen; hydrocodone bitartrate
CAPSULE;ORAL087336-001Jul 8, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
MORPHINE SULFATE
morphine sulfate
TABLET, EXTENDED RELEASE;ORAL076412-001Jul 31, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Mallinckrodt

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
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 1991► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Hosp
UVADEX
methoxsalen
INJECTABLE;INJECTION020969-001Feb 25, 1999► Subscribe► Subscribe
Mallinckrodt Llc
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL018013-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Llc
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL018013-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► 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
9,198,861Methods 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
9,539,328Tamper 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
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 Drugs

Country Document Number Estimated Expiration
Japan2011503198► Subscribe
Austria256455► Subscribe
Australia2015218945► Subscribe
Czech Republic298427► Subscribe
Australia2011345329► Subscribe
Australia3989301► Subscribe
Spain2201316► Subscribe
African Regional IP Organization (ARIPO)9801223► Subscribe
Hungary226117► Subscribe
Canada2409552► 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
00152Netherlands► SubscribePRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
99C0030Belgium► SubscribePRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 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/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
C/GB08/019United Kingdom► SubscribePRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
C/GB08/020United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
00673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
C/GB00/021United Kingdom► SubscribePRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
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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:

Colorcon
Covington
Chubb
Federal Trade Commission
Novartis
Teva
QuintilesIMS
Cantor Fitzgerald
Boehringer Ingelheim
Julphar

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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