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Details for New Drug Application (NDA): 020685
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NDA 020685 describes CRIXIVAN, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CRIXIVAN profile page.
The generic ingredient in CRIXIVAN is indinavir sulfate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indinavir sulfate profile page.
The generic ingredient in CRIXIVAN is indinavir sulfate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indinavir sulfate profile page.
Summary for 020685
| Tradename: | CRIXIVAN |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | indinavir sulfate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 020685
Generic Entry Date for 020685*:
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: 020685
| Mechanism of Action | HIV Protease Inhibitors Cytochrome P450 3A4 Inhibitors |
Medical Subject Heading (MeSH) Categories for 020685
Suppliers and Packaging for NDA: 020685
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685 | NDA | Merck Sharp & Dohme Corp. | 0006-0571 | 0006-0571-43 | 360 CAPSULE in 1 BOTTLE (0006-0571-43) |
| CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685 | NDA | Merck Sharp & Dohme Corp. | 0006-0573 | 0006-0573-62 | 180 CAPSULE in 1 BOTTLE (0006-0573-62) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Mar 13, 1996 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Feb 10, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Mar 13, 1996 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Feb 10, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS | ||||||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 333MG BASE | ||||
| Approval Date: | Dec 17, 1998 | TE: | RLD: | No | |||||
| Patent: | Start Trial | Patent Expiration: | Feb 10, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS | ||||||||
Expired US Patents for NDA 020685
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-005 | Dec 17, 1998 | Start Trial | Start Trial |
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-005 | Dec 17, 1998 | Start Trial | Start Trial |
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-006 | Apr 19, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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