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Efavirenz - Generic Drug Details
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What are the generic drug sources for efavirenz and what is the scope of patent protection?
Efavirenz
is the generic ingredient in seven branded drugs marketed by Aurobindo Pharma Ltd, Bristol Myers Squibb, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Gilead Sciences, Teva Pharms Usa, Laurus Labs Ltd, Macleods Pharms Ltd, and Mylan Labs Ltd, and is included in nineteen NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are twenty-six drug master file entries for efavirenz. Nine suppliers are listed for this compound. There are twenty-one tentative approvals for this compound.
Summary for efavirenz
US Patents: | 9 |
Tradenames: | 7 |
Applicants: | 11 |
NDAs: | 19 |
Drug Master File Entries: | 26 |
Suppliers / Packagers: | 9 |
Bulk Api Vendors: | 91 |
Clinical Trials: | 394 |
Patent Applications: | 7,193 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for efavirenz |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for efavirenz |
What excipients (inactive ingredients) are in efavirenz? | efavirenz excipients list |
DailyMed Link: | efavirenz at DailyMed |
Recent Clinical Trials for efavirenz
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Phase 4 |
Allergan, plc | Phase 2 |
Jiangsu HengRui Medicine Co., Ltd. | Phase 1 |
Generic filers with tentative approvals for EFAVIRENZ
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 200MG | TABLET; ORAL |
Start Trial | Start Trial | 200MG | TABLET; ORAL |
Start Trial | Start Trial | 100MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for efavirenz
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Cipla | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 206894-001 | Jun 3, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Laurus Labs Ltd | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 212786-001 | May 14, 2020 | AB | RX | 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 efavirenz
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-001 | Feb 1, 2002 | Start Trial | Start Trial |
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-003 | Sep 17, 1998 | Start Trial | Start Trial |
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-003 | Sep 17, 1998 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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