Details for New Drug Application (NDA): 203858
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NDA 203858 describes JUXTAPID, which is a drug marketed by Chiesi and is included in one NDA. It is available from three suppliers. There are eight patents protecting this drug. Additional details are available on the JUXTAPID profile page.
The generic ingredient in JUXTAPID is lomitapide mesylate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lomitapide mesylate profile page.
The generic ingredient in JUXTAPID is lomitapide mesylate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lomitapide mesylate profile page.
Summary for 203858
| Tradename: | JUXTAPID |
| Applicant: | Chiesi |
| Ingredient: | lomitapide mesylate |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203858
Generic Entry Date for 203858*:
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 NDA: 203858
Suppliers and Packaging for NDA: 203858
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858 | NDA | Chiesi USA, Inc. | 10122-405 | 10122-405-28 | 28 CAPSULE in 1 BOTTLE (10122-405-28) |
| JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858 | NDA | Chiesi USA, Inc. | 10122-410 | 10122-410-28 | 28 CAPSULE in 1 BOTTLE (10122-410-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Dec 21, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 7, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 7, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 19, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES | ||||||||
Expired US Patents for NDA 203858
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-003 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-006 | Apr 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-005 | Apr 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-001 | Dec 21, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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