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
*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 | 203858-003 | 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 | 203858-006 | 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 | ||||
| >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 | 203858-006 | 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 | 203858-003 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-002 | Dec 21, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lomitapide mesylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2012232995 | METHOD FOR TREATING DISORDER OR DISEASE ASSOCIATED WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING SIDE EFFECT | ⤷ Sign Up |
| Lithuania | C1725234 | ⤷ Sign Up | |
| Denmark | 1725234 | ⤷ 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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lomitapide mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 92349 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LOMITAPIDE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130805 |
| 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 | 498 | Finland | ⤷ Sign Up | |
| >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.
ISSN: 2162-2639
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