Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Chubb
Harvard Business School
Healthtrust
Farmers Insurance
Argus Health
Citi
US Department of Justice
Fish and Richardson

Generated: October 23, 2017

DrugPatentWatch Database Preview

Mallinckrodt Company Profile

« Back to Dashboard

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-eight patent family members on MALLINCKRODT drugs in thirty countries and sixty supplementary protection certificates in eleven countries.

Summary for Applicant: Mallinckrodt

International Patents:128
US 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 Inc
METHYLIN ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL075629-002May 9, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
CHOLEBRINE
iocetamic acid
TABLET;ORAL017129-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Ip
OFIRMEV
acetaminophen
SOLUTION;IV (INFUSION)022450-001Nov 2, 2010APRXYesYes► Subscribe► SubscribeY► Subscribe
Mallinckrodt
METHADONE HYDROCHLORIDE
methadone hydrochloride
TABLET;ORAL040517-002Apr 27, 2004AARXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
ROXICODONE
oxycodone hydrochloride
TABLET;ORAL021011-003May 15, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Mallinckrodt Inc
METHADONE HYDROCHLORIDE
methadone hydrochloride
POWDER;FOR RX COMPOUNDING006383-003Approved Prior to Jan 1, 1982RXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL075983-001Jun 25, 2002ABRXNoNo► Subscribe► 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► Subscribe
Mallinckrodt
METHYLIN
methylphenidate hydrochloride
SOLUTION;ORAL021419-001Dec 19, 2002AARXYesYes► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Mallinckrodt

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 2010► 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 Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt Hosp
UVADEX
methoxsalen
INJECTABLE;INJECTION020969-001Feb 25, 1999► Subscribe► Subscribe
Mallinckrodt Inc
PAMELOR
nortriptyline hydrochloride
SOLUTION;ORAL018012-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mallinckrodt Llc
PAMELOR
nortriptyline hydrochloride
CAPSULE;ORAL018013-001Approved 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;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
9,539,328Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
8,790,694Gastric 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
9,433,582Gastric retentive extended release pharmaceutical compositions► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Mallinckrodt Drugs

Country Document Number Estimated Expiration
Austria256455► Subscribe
Hungary9901893► Subscribe
China103402499► Subscribe
MexicoPA06003725► Subscribe
Japan5060681► Subscribe
Canada2233924► Subscribe
Austria241972► Subscribe
Morocco26926► Subscribe
TaiwanI237570► Subscribe
Canada2409552► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Mallinckrodt Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/012United Kingdom► SubscribePRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
C/GB08/019United Kingdom► SubscribePRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
C0005Belgium► SubscribePRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
C0050France► SubscribePRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/428/001 DU 20080111; REGISTRATION NO/DATE AT EEC: EU/1/07/428/001 DU 20080111
00152Netherlands► SubscribePRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
C0025Belgium► SubscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
02C/003Belgium► SubscribePRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Similar Applicant Names

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

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
McKesson
Daiichi Sankyo
Teva
Covington
Fish and Richardson
QuintilesIMS
Chubb
Deloitte
Chinese Patent Office

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot