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Generated: August 17, 2017
What are the generic sources for tenofovir disoproxil fumarate and what is the scope of tenofovir disoproxil fumarate patent protection?
Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Teva Pharms Usa and Gilead Sciences Inc, and is included in three NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 4 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: see list | 36 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 51 |
| Clinical Trials: see list | 884 |
| Patent Applications: see list | 3,346 |
| Therapeutic Class: | Antivirals |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | tenofovir disoproxil fumarate at DailyMed |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 300MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 300MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 300MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-003 | Jan 18, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-002 | Jan 18, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,069,249 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability | ► Subscribe | |||||||||||||||||||||||||||
| RE38333 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2014159450 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 100707505 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 122008000033 | ► Subscribe | |||||||||||||||||||||||||||
| China | 100383148 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1264387 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0032 | France | ► Subscribe | PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221 | ||||||||||||||||||||||||||
| 0915894/02 | Switzerland | ► Subscribe | PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009 | ||||||||||||||||||||||||||
| C/GB08/022 | United Kingdom | ► Subscribe | PRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213 | ||||||||||||||||||||||||||
| 2015037 | Lithuania | ► Subscribe | PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128 | ||||||||||||||||||||||||||
| 2016038 | Lithuania | ► Subscribe | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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