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Last Updated: September 19, 2020

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Lomitapide mesylate - Generic Drug Details

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What are the generic drug sources for lomitapide mesylate and what is the scope of freedom to operate?

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

Lomitapide mesylate has ninety-two patent family members in thirty-seven countries.

There are two drug master file entries for lomitapide mesylate.

Summary 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
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
>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
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012   Start Trial   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012   Start Trial   Start Trial
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lomitapide mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725234 2/2014 Austria   Start Trial PRODUCT NAME: LOMITAPID BZW. DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE; REGISTRATION NO/DATE: EU/1/13/851/001-EU/1/13/851/003 20130731
1725234 498 Finland   Start Trial
1725234 300634 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
McKesson
Express Scripts
Boehringer Ingelheim
AstraZeneca
McKinsey

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