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Generated: June 25, 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 five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 5 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: see list | 33 |
| Suppliers / Packagers: see list | 4 |
| Bulk Api Vendors: see list | 51 |
| Clinical Trials: see list | 876 |
| 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 | 021356-004 | Jan 18, 2012 | RX | Yes | No | 5,922,695*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | RX | Yes | No | 5,977,089*PED | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | AB | RX | Yes | Yes | 5,922,695*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | AB | RX | Yes | Yes | 6,043,230*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-003 | Jan 18, 2012 | RX | Yes | No | 5,977,089*PED | ► Subscribe | Y | ► 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 | 4,808,716 | ► Subscribe | ||||||||||||||||||||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-001 | Oct 26, 2001 | 6,057,305 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 100707505 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1243593 | ► Subscribe | |||||||||||||||||||||||||||
| China | 100383148 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 0915894 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1243593 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016 00063 | Denmark | ► Subscribe | PRODUCT NAME: RILPIVIRINHYDROCHLORID OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 | ||||||||||||||||||||||||||
| C0020 | France | ► Subscribe | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 | ||||||||||||||||||||||||||
| 2016042 | Lithuania | ► Subscribe | PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 | ||||||||||||||||||||||||||
| C/GB08/033 | United Kingdom | ► Subscribe | PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED | ||||||||||||||||||||||||||
| 2015 00055 | Denmark | ► Subscribe | PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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