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Last Updated: November 2, 2024

LOMITAPIDE MESYLATE - Generic Drug Details


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What are the generic sources for lomitapide mesylate and what is the scope of patent protection?

Lomitapide mesylate is the generic ingredient in one branded drug marketed by Chiesi and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lomitapide mesylate has twenty-seven patent family members in eighteen countries.

There are two drug master file entries for lomitapide mesylate. Three suppliers are listed for this compound.

Summary for LOMITAPIDE MESYLATE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LOMITAPIDE MESYLATE
Generic Entry Date for LOMITAPIDE MESYLATE*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for LOMITAPIDE MESYLATE

US Patents and Regulatory Information for LOMITAPIDE MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No ⤷  Sign Up ⤷  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

Expired US Patents for LOMITAPIDE MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015 ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015 ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LOMITAPIDE MESYLATE

Country Patent Number Title Estimated Expiration
Spain 2399721 ⤷  Sign Up
Croatia P20130115 ⤷  Sign Up
Slovenia 1725234 ⤷  Sign Up
Japan 5902760 ⤷  Sign Up
European Patent Office 1725234 TRAITEMENT A FAIBLES EFFETS SECONDAIRES CONTRE DES AFFECTIONS LIEES A L'HYPERLIPIDEMIE ET L'HYPERCHOLESTEROLEMIE (METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS) ⤷  Sign Up
South Korea 20060129082 METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LOMITAPIDE MESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725234 CR 2014 00002 Denmark ⤷  Sign Up PRODUCT NAME: LOMITAPID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER PIPERIDIN N-OXIDET DERAF, HERUNDER LOMITAPIDMESYLAT; REG. NO/DATE: EU/1/13/851/001-003 20130805
1725234 2/2014 Austria ⤷  Sign Up PRODUCT NAME: LOMITAPID BZW. DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE; REGISTRATION NO/DATE: EU/1/13/851/001-EU/1/13/851/003 20130731
1725234 300634 Netherlands ⤷  Sign Up PRODUCT NAME: LOMITAPIDE OF HET PIPERIDINE N-OXIDE DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130805
1725234 122014000003 Germany ⤷  Sign Up PRODUCT NAME: LOMITAPID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER DAS PIPERIDIN-N-OXID DAVON; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234 2013/063 Ireland ⤷  Sign Up PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234 206 5001-2014 Slovakia ⤷  Sign Up PRODUCT NAME: LOMITAPID; REGISTRATION NO/DATE: EU/1/13/851/001 - EU/1/13/851/003 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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