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 |
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 for Free | 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 for Free | 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 for Free | 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 | 203858-002 | Dec 21, 2012 | ⤷ Try for Free | ⤷ Try for Free |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-005 | Apr 23, 2015 | ⤷ Try for Free | ⤷ Try for Free |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-004 | Apr 23, 2015 | ⤷ Try for Free | ⤷ Try for Free |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-004 | Apr 23, 2015 | ⤷ Try for Free | ⤷ Try for Free |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-004 | Apr 23, 2015 | ⤷ Try for Free | ⤷ Try for Free |
| Chiesi | JUXTAPID | lomitapide mesylate | CAPSULE;ORAL | 203858-006 | Apr 23, 2015 | ⤷ Try for Free | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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