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Generated: May 30, 2017
What are the generic drug sources for efavirenz and what is the scope of efavirenz freedom to operate?
Efavirenz is the generic ingredient in three branded drugs marketed by Bristol Myers Squibb, Mylan Pharms Inc, and Gilead, and is included in four NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 18 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: see list | 25 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 55 |
| Clinical Trials: see list | 105 |
| Patent Applications: see list | 5,336 |
| Therapeutic Class: | Antivirals |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | efavirenz at DailyMed |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 600MG; 300MG; 300MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 600MG; 300MG; 300MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 200MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-003 | Sep 17, 1998 | RX | Yes | Yes | 6,939,964*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-001 | Sep 17, 1998 | RX | Yes | No | 6,555,133*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-002 | Feb 1, 2002 | AB | RX | Yes | Yes | 6,939,964*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-002 | Sep 17, 1998 | DISCN | Yes | No | 6,939,964*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-001 | Sep 17, 1998 | RX | Yes | No | 6,238,695*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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Expired Orange Book Patents
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Paragraph IV Activity
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Patent Maintenance
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Non-Orange Book Patents
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International Patents
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Supplementary Protection Certificates
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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 verifification 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.
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