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

International Patents:	27
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	54
Patent Applications:	385
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lomitapide mesylate

Generic Entry Date for lomitapide mesylate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Pharmacology for lomitapide mesylate

Drug Class	Microsomal Triglyceride Transfer Protein Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Microsomal Triglyceride Transfer Protein Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lomitapide mesylate

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for lomitapide mesylate

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Glossary

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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	203858-001	Dec 21, 2012		RX	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
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	203858-001	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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	203858-005	Apr 23, 2015	⤷ 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	203858-002	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

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Country	Patent Number	Title	Estimated Expiration
Japan	6189918		⤷ Sign Up
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
Japan	2012232995	METHOD FOR TREATING DISORDER OR DISEASE ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE EFFECT	⤷ Sign Up
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)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005087234		⤷ Sign Up
Cyprus	1114218		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lomitapide mesylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725234	14C0003	France	⤷ Sign Up	PRODUCT NAME: LOMITAPIDE , OU UN SEL PHARMACEUTIQUEMENT ACTIF DE CELUI-CI.; REGISTRATION NO/DATE: EU/1/13/851/001 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	206 5001-2014	Slovakia	⤷ Sign Up	PRODUCT NAME: LOMITAPID; REGISTRATION NO/DATE: EU/1/13/851/001 - EU/1/13/851/003 20130805
1725234	PA2014001,C1725234	Lithuania	⤷ Sign Up	PRODUCT NAME: LOMITAPIDAS; REGISTRATION NO/DATE: EU/1/13/851/001, 2013-07-31 EU/1/13/851/002, 2013-07-31 EU/1/13/851/003 20130731
1725234	C 2014 003	Romania	⤷ Sign Up	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	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
>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.

Summary for lomitapide mesylate

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lomitapide mesylate

Pharmacology for lomitapide mesylate

Anatomical Therapeutic Chemical (ATC) Classes for lomitapide mesylate

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lomitapide mesylate