Details for New Drug Application (NDA): 203858
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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 |
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | 203858-005 | 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 |
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