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

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
Healthtrust
Moodys
Julphar
Novartis
Johnson and Johnson
Teva
Fuji
Colorcon

Generated: February 21, 2018

DrugPatentWatch Database Preview

Mallinckrodt Inc Company Profile

« Back to Dashboard

Summary for Mallinckrodt Inc
International Patents:46
US Patents:13
Tradenames:4
Ingredients:4
NDAs:4
Drug Master File Entries: 71

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 XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 8,658,631 ➤ Sign Up Y ➤ Sign Up
Mallinckrodt Inc METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383-004 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 8,394,408 ➤ Sign Up Y ➤ Sign Up
Mallinckrodt Inc METHADONE HYDROCHLORIDE methadone hydrochloride POWDER;FOR RX COMPOUNDING 006383-003 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 8,668,929 ➤ Sign Up ➤ Sign Up
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 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 8,741,885 ➤ Sign Up Y ➤ Sign Up
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No 7,976,870 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for MALLINCKRODT INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 7.5 mg/325 mg ➤ Subscribe 4/3/2014

Non-Orange Book US 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
9,198,861 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans ➤ Sign Up
9,433,582 Gastric retentive extended release pharmaceutical compositions ➤ Sign Up
9,539,328 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Sign Up
9,629,837 Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia ➤ Sign Up
8,790,694 Gastric retentive extended release pharmaceutical compositions ➤ Sign Up
8,858,963 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for Mallinckrodt Inc Drugs

Supplementary Protection Certificates for Mallinckrodt Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/025 United Kingdom ➤ Sign Up PRODUCT 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
C0018 France ➤ Sign Up PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
C0005 Belgium ➤ Sign Up PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
C0076 France ➤ Sign Up PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
15/009 Ireland ➤ Sign Up PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
90064-1 Sweden ➤ Sign Up PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
C/GB97/078 United Kingdom ➤ Sign Up PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
C0108 Belgium ➤ Sign Up PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
90020-1 Sweden ➤ Sign Up PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
C0041 France ➤ Sign Up PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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

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

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Fish and Richardson
AstraZeneca
Chubb
Medtronic
Johnson and Johnson
Fuji
Healthtrust

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.

botpot