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Indinavir sulfate - Generic Drug Details
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What are the generic sources for indinavir sulfate and what is the scope of freedom to operate?
Indinavir sulfate
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Indinavir sulfate has forty-two patent family members in thirty-five countries.
There are two drug master file entries for indinavir sulfate. One supplier is listed for this compound.
Summary for indinavir sulfate
| International Patents: | 42 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 58 |
| Clinical Trials: | 81 |
| Patent Applications: | 4,144 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | indinavir sulfate at DailyMed |
Recent Clinical Trials for indinavir sulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oncology Institute of Southern Switzerland | Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | N/A |
| PPD | Phase 3 |
Pharmacology for indinavir sulfate
| Drug Class | Protease Inhibitor |
| Mechanism of Action | HIV Protease Inhibitors Cytochrome P450 3A4 Inhibitors |
Medical Subject Heading (MeSH) Categories for indinavir sulfate
US Patents and Regulatory Information for indinavir sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-003 | Mar 13, 1996 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-001 | Mar 13, 1996 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-006 | Apr 19, 2000 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-005 | Dec 17, 1998 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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 indinavir sulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-006 | Apr 19, 2000 | Start Trial | Start Trial |
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-001 | Mar 13, 1996 | 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 | 020685-005 | Dec 17, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for indinavir sulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 116925 | Start Trial |
| Malaysia | 121604 | Start Trial |
| Slovakia | 103797 | Start Trial |
| Yugoslavia | 6396 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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