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Last Updated: November 22, 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 203858-006 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 203858-006 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 203858-003 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 ⤷  Sign Up ⤷  Sign Up
Chiesi JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 ⤷  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
Montenegro 02070 POSTUPCI ZA LEČENJE POREMEĆAJA ILI BOLESTI POVEZANIH SA HIPERLIPIDEMIJOM I HIPERHOLESTEROLEMIJOM UZ MINIMIZACIJU SPOREDNIH EFEKATA (METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS) ⤷  Sign Up
Lithuania C1725234 ⤷  Sign Up
South Korea 20130004942 METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS ⤷  Sign Up
Japan 2007527433 ⤷  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 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 SPC/GB14/005 United Kingdom ⤷  Sign Up PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR THE PIPERIDINE N-OXIDE THEREOF; REGISTERED: UK EU/1/13/851/001 20130805; UK EU/1/13/851/002 20130805; UK EU/1/13/851/003 20130805
1725234 132014902228079 Italy ⤷  Sign Up PRODUCT NAME: LOMITAPIDE E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE COME PROTETTA DAL BREVETTO BASE(LOJUXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/851/001/-003, 20130805
1725234 C20140001 00107 Estonia ⤷  Sign Up PRODUCT NAME: LOMITAPIID;REG NO/DATE: K(2013)5153(LOPLIK) 05.08.2013
>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.