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Efavirenz - Generic Drug Details
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This ingredient has sixty-eight patent family members in twenty-seven countries.
There are twenty-three drug master file entries for efavirenz. Four suppliers are listed for this compound. There are twenty-eight tentative approvals for this compound.
Summary for Generic Name: efavirenz
| Tradenames: | 3 |
| Patents: | 16 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: see list | 23 |
| Suppliers / Packaging: see list | 4 |
| Therapeutic Class: | Antivirals |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: efavirenz
Tentative approvals for EFAVIRENZ
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET; ORAL | 600MG; 300MG; 300MG |
| <disabled> | <disabled> | TABLET; ORAL | 600MG; 300MG; 300MG |
| <disabled> | <disabled> | TABLET; ORAL | 200MG |
Clinical Trials for: efavirenz
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-001 | Feb 1, 2002 | DISCN | No | 6,939,964*PED | Jul 20, 2018 | Y | |||||||||||||||||||
Gilead | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | RX | Yes | 5,935,946*PED | Jan 25, 2018 | Y | |||||||||||||||||||
Mylan Pharms Inc | EFAVIRENZ | efavirenz | TABLET;ORAL | 091471-001 | Feb 17, 2016 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: efavirenz
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-001 | Sep 17, 1998 | 5,519,021*PED | <disabled> | ||||||||||||||||||||||
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-001 | Sep 17, 1998 | 5,811,423 | <disabled> | ||||||||||||||||||||||
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-002 | Feb 1, 2002 | 5,519,021*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: efavirenz
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,965,729 | Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: efavirenz
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69841972 | <disabled in preview> | |||||||||||||||||||||||||||
| Norway | 993779 | <disabled in preview> | |||||||||||||||||||||||||||
| Hungary | 229087 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: EFAVIRENZ
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB00/035 | United Kingdom | <disabled> | PRODUCT NAME: EFAVIRENZ, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH IKS-54 908 01 19981120; CH IKS-54 908 02 19981120; CH IKS-54 908 03 19981120; UK EU/1/99/110/001 19990528; UK EU/1/99/110/002 19990528; UK EU/1/99/110/003 19990528; UK EU/1/99/110/004 19990528; UK EU/1/99/111/001 19990528; UK EU/1/99/111/002 19990528; UK EU/1/99/111/003 19990528; UK EU/1/99/111/004 19990528 | ||||||||||||||||||||||||||
| 00032 | Netherlands | <disabled> | PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528 | ||||||||||||||||||||||||||
| /2000 | Austria | <disabled> | PRODUCT NAME: EFAVIRENZ, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/99/110/001-004 1/99/111/001-004 19990528; FIRST REGISTRATION: LI 54908 01, 54908 02, 54908 03 19981120 | ||||||||||||||||||||||||||
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