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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Chubb
Argus Health
US Army
Cipla
Teva
US Department of Justice
Fish and Richardson

Generated: August 16, 2018

DrugPatentWatch Database Preview

Mallinckrodt Company Profile

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Summary for Mallinckrodt

Drugs and US Patents for Mallinckrodt

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt ANEXSIA acetaminophen; hydrocodone bitartrate TABLET;ORAL 089160-001 Apr 23, 1987 DISCN No No ➤ Sign Up ➤ Sign Up
Mallinckrodt SODIUM PHOSPHATE P 32 sodium phosphate p-32 SOLUTION;INJECTION, ORAL 011777-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Mallinckrodt HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040084-003 Jul 29, 1996 DISCN No No ➤ Sign Up ➤ Sign Up
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 RX Yes Yes 8,573,209*PED ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Mallinckrodt

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 6,125,846*PED ➤ Sign Up
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 5,485,827*PED ➤ Sign Up
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 6,125,846*PED ➤ Sign Up
Mallinckrodt Hosp UVADEX methoxsalen INJECTABLE;INJECTION 020969-001 Feb 25, 1999 5,036,102 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MALLINCKRODT drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe for Inhalation 100 ppm and 800 ppm ➤ Subscribe 2014-05-20
➤ Subscribe Injection 1000 mg/100 mL (10 mg/mL) ➤ Subscribe 2011-04-07
➤ Subscribe Extended-release Tablets 7.5 mg/325 mg ➤ Subscribe 2014-04-03
Premature patent expirations for MALLINCKRODT

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book US 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
9,629,837 Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia ➤ Sign Up
9,198,861 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans ➤ Sign Up
8,858,963 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Sign Up
8,790,694 Gastric retentive extended release pharmaceutical compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Mallinckrodt Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0041 France ➤ Sign Up PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
C0025 Belgium ➤ Sign Up PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0736 Netherlands ➤ Sign Up PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119
C/GB02/042 United Kingdom ➤ Sign Up PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
US Department of Justice
Julphar
Boehringer Ingelheim
QuintilesIMS
UBS
Fish and Richardson
Chubb

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.