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*:
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.
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
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 | 203858-001 | Dec 21, 2012 | RX | Yes | No | 10,016,404 | ⤷ Subscribe | ⤷ Subscribe | ||||
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-002 | Dec 21, 2012 | RX | Yes | No | 9,861,622 | ⤷ Subscribe | ⤷ Subscribe | ||||
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-003 | Dec 21, 2012 | RX | Yes | No | 9,265,758 | ⤷ Subscribe | ⤷ Subscribe | ||||
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-005 | Apr 23, 2015 | DISCN | Yes | No | 7,932,268 | ⤷ Subscribe | ⤷ Subscribe | ||||
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-002 | Dec 21, 2012 | RX | Yes | No | 10,016,404 | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 203858-002 | Dec 21, 2012 | 6,492,365 | ⤷ Subscribe |
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-001 | Dec 21, 2012 | 5,712,279 | ⤷ Subscribe |
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-002 | Dec 21, 2012 | 5,712,279 | ⤷ Subscribe |
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-003 | Dec 21, 2012 | 6,492,365 | ⤷ Subscribe |
Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-006 | Apr 23, 2015 | 6,492,365 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lomitapide mesylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1114218 | ⤷ Subscribe | |
Japan | 2012232995 | METHOD FOR TREATING DISORDER OR DISEASE ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE EFFECT | ⤷ Subscribe |
Spain | 2399721 | ⤷ Subscribe | |
Poland | 1725234 | ⤷ Subscribe | |
Netherlands | 300634 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lomitapide mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1725234 | 1490006-2 | Sweden | ⤷ Subscribe | PRODUCT NAME: LOMITAPID OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/851/001 20130731 |
1725234 | 2013/063 | Ireland | ⤷ Subscribe | PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731 |
1725234 | C 2014 003 | Romania | ⤷ Subscribe | 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 | CR 2014 00002 | Denmark | ⤷ Subscribe | PRODUCT NAME: LOMITAPID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER PIPERIDIN N-OXIDET DERAF, HERUNDER LOMITAPIDMESYLAT; REG. NO/DATE: EU/1/13/851/001-003 20130805 |
1725234 | C300634 | Netherlands | ⤷ Subscribe | PRODUCT NAME: LOMITAPIDE EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS DOOR HET BASISOCTROOI BESCHERMD; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Lomitapide mesylate Market Analysis and Financial Projection Experimental
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