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Last Updated: July 16, 2024

Mallinckrodt Inc Company Profile


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Summary for Mallinckrodt Inc
International Patents:31
US Patents:12
Tradenames:4
Ingredients:4
NDAs:4
Drug Master File Entries: 67

Drugs and US Patents for Mallinckrodt Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 8,372,432 ⤷  Sign Up Y ⤷  Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 8,377,453 ⤷  Sign Up Y ⤷  Sign Up
Mallinckrodt Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 040508-001 Aug 29, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 8,668,929 ⤷  Sign Up ⤷  Sign Up
Mallinckrodt Inc BAROS sodium bicarbonate; tartaric acid GRANULE, EFFERVESCENT;ORAL 018509-001 Aug 7, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 8,980,319 ⤷  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
Paragraph IV (Patent) Challenges for MALLINCKRODT INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 7.5 mg/325 mg ➤ Subscribe 2014-04-03
Premature patent expirations for MALLINCKRODT INC

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
⤷  Sign Up ⤷  Sign Up

Supplementary Protection Certificates for Mallinckrodt Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822954 2018/031 Ireland ⤷  Sign Up PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0788511 SPC/GB08/036 United Kingdom ⤷  Sign Up PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1499331 SPC/GB13/034 United Kingdom ⤷  Sign Up PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
1175904 2007C/048 Belgium ⤷  Sign Up PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2822954 SPC/GB18/031 United Kingdom ⤷  Sign Up PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
2666774 LUC00167 Luxembourg ⤷  Sign Up PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
1912999 1490062-5 Sweden ⤷  Sign Up PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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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 verification 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.