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	203858-002	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
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		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	203858-005	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
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012	⤷ Sign Up	⤷ Sign Up
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015	⤷ 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
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
Canada	2910191	L'UTILISATION D'INHIBITEURS MTP POUR LE TRAITEMENT A FAIBLES EFFETS SECONDAIRES CONTRE DES AFFECTIONS LIEES A L'HYPERLIPIDEMIE ET L'HYPERCHOLESTEROLEMIE (THE USE OF MTP INHIBITORS FOR TREATING DISORDERS OR DISEASES ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE EFFECTS)	⤷ Sign Up
Croatia	P20130115		⤷ 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	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
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	2013/063	Ireland	⤷ Sign Up	PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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