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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 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
International Patents: | 92 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Bulk Api Vendors: | 37 |
Patent Applications: | 4 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lomitapide mesylate |
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 | 203858-006 | Apr 23, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Amryt | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-006 | Apr 23, 2015 | DISCN | Yes | No | Start Trial | Start Trial | 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 | 203858-003 | Dec 21, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Amryt | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-004 | Apr 23, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Amryt | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-005 | Apr 23, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Amryt | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-004 | Apr 23, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | 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 | 203858-001 | Dec 21, 2012 | Start Trial | Start Trial |
Amryt | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-005 | Apr 23, 2015 | Start Trial | Start Trial |
Amryt | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-004 | Apr 23, 2015 | Start Trial | Start Trial |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lomitapide mesylate
Country | Patent Number | Estimated Expiration |
---|---|---|
Austria | 283851 | Start Trial |
Hungary | 9300627 | Start Trial |
Australia | 3406493 | Start Trial |
Croatia | P20130115 | Start Trial |
Israel | 110803 | Start Trial |
Norway | 943260 | Start Trial |
Australia | 4763196 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for lomitapide mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1725234 | 2014C/002 | Belgium | Start Trial | PRODUCT NAME: LOMITAPIDE ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE TELLE QUE PROTEGEE PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/851/001 20130805 |
1725234 | CA 2014 00002 | Denmark | Start Trial | PRODUCT NAME: LOMITAPID OG ENHVER TERAPEUTISK AEKVIVALENT FORM DERAF, SOM BESKYTTET I GRUNDPATENTET; REG. NO/DATE: EU/1/13/851/001-003 20130731 |
1725234 | CR 2014 00002 | Denmark | Start Trial | 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 | 2013/063 | Ireland | Start Trial | PRODUCT NAME: LOMITAPIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/851/001-003 20130731 |
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 |
1725234 | 92349 | Luxembourg | Start Trial | PRODUCT NAME: LOMITAPIDE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130805 |
1725234 | 122014000003 | Germany | Start Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |