.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Cerilliant
Harvard Business School
US Army
Colorcon
Boehringer Ingelheim
Baxter
Novartis
Moodys
Federal Trade Commission
UBS

Generated: September 24, 2017

DrugPatentWatch Database Preview

Mallinckrodt Inc Company Profile

« Back to Dashboard

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.

Summary for Applicant: Mallinckrodt Inc

Patents:13
Tradenames:28
Ingredients:19
NDAs:29
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
RESTORIL
temazepam
CAPSULE;ORAL018163-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Mallinckrodt Inc
PAMELOR
nortriptyline hydrochloride
SOLUTION;ORAL018012-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
MORPHINE SULFATE
morphine sulfate
SOLUTION;ORAL202348-001Jul 15, 2011AARXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL202946-005Jun 27, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Mallinckrodt Inc
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040440-002Oct 7, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride
TABLET;ORAL087846-003May 22, 1984ABRXNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► 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 Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 1991► Subscribe► Subscribe
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 1991► Subscribe► Subscribe
Mallinckrodt Inc
PAMELOR
nortriptyline hydrochloride
SOLUTION;ORAL018012-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-002Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010► Subscribe► Subscribe
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 1991► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 2012► Subscribe► Subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 2010► 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 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
9,198,861Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans► Subscribe
9,539,328Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
9,433,582Gastric retentive extended release pharmaceutical compositions► 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
9,629,837Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia► 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 Inc Drugs

Country Document Number Estimated Expiration
European Patent Office2262484► Subscribe
China102105136► Subscribe
Denmark1294363► Subscribe
South Korea101748906► Subscribe
South Korea20140021992► Subscribe
South Korea100716756► Subscribe
Japan2003535886► Subscribe
Australia2001239893► Subscribe
South Africa201303988► Subscribe
World Intellectual Property Organization (WIPO)03035041► 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 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
99C0030Belgium► SubscribePRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
90018-6Sweden► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
C0108Belgium► SubscribePRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
292Luxembourg► SubscribePRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
14/032Ireland► SubscribePRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
C0013France► SubscribePRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
C0021France► SubscribePRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
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 500+ biopharmaceutical companies globally:

McKinsey
Teva
Dow
Boehringer Ingelheim
Chubb
US Army
Queensland Health
Moodys
Cantor Fitzgerald
Express Scripts

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 Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot