Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Baxter
Express Scripts
McKesson
Moodys

Last Updated: October 6, 2022

Lomitapide mesylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 Amryt 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.

Summary for lomitapide mesylate
International Patents:27
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 48
Patent Applications: 568
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for lomitapide mesylate
What excipients (inactive ingredients) are in lomitapide mesylate?lomitapide mesylate excipients list
DailyMed Link:lomitapide mesylate at DailyMed

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 203858-005 Apr 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-005 Apr 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-001 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-004 Apr 23, 2015 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-006 Apr 23, 2015 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-002 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
Amryt JUXTAPID lomitapide mesylate CAPSULE;ORAL 203858-003 Dec 21, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lomitapide mesylate

Country Patent Number Title Estimated Expiration
Japan 2007527433 See Plans and Pricing
Japan 2012232995 METHOD FOR TREATING DISORDER OR DISEASE ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE EFFECT See Plans and Pricing
Japan 2014208683 高脂血症および高コレステロール血症に関連する障害または疾患を、副作用を最小限にしつつ処置するための方法 (METHOD FOR TREATMENT OF DISORDER OR DISEASE ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA, WHILE MINIMIZING ADVERSE EFFECT) See Plans and Pricing
South Korea 20130004942 METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS See Plans and Pricing
Netherlands 300634 See Plans and Pricing
Japan 2016135762 高脂血症および高コレステロール血症に関連する障害または疾患を、副作用を最小限にしつつ処置するための方法 (METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE-EFFECTS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lomitapide mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1725234 132014902228079 Italy See Plans and Pricing 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 SPC/GB14/005 United Kingdom See Plans and Pricing 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 C 2014 003 Romania See Plans and Pricing PRODUCT NAME: LOMITAPIDA SAU O SARE ACCEPTABILA FARMACEUTIC SAU PIPERIDIN-N-OXIDUL ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/851/001-003; DATE OF NATIONAL AUTHORISATION: 20130731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/851/001-003; DATE OF FIRST AUTHORISATION IN EEA: 20130731
1725234 206 5001-2014 Slovakia See Plans and Pricing PRODUCT NAME: LOMITAPID; REGISTRATION NO/DATE: EU/1/13/851/001 - EU/1/13/851/003 20130805
1725234 2013/063 Ireland See Plans and Pricing PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
1725234 14C0003 France See Plans and Pricing PRODUCT NAME: LOMITAPIDE , OU UN SEL PHARMACEUTIQUEMENT ACTIF DE CELUI-CI.; REGISTRATION NO/DATE: EU/1/13/851/001 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Boehringer Ingelheim
AstraZeneca
Baxter
McKinsey

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.