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Generated: June 25, 2017
Which patents cover Epivir, and what generic Epivir alternatives are available?
Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. There are two patents protecting this drug and three Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 4 |
| Suppliers / Packagers: see list | 5 |
| Bulk Api Vendors: see list | 87 |
| Clinical Trials: see list | 28 |
| Patent Applications: see list | 2,054 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | EPIVIR at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | AB | RX | Yes | No | 5,905,082*PED | ► Subscribe | ► Subscribe | |||||||||||||||||
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | AA | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | AB | RX | Yes | Yes | 5,905,082*PED | ► Subscribe | ► Subscribe | |||||||||||||||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | 7,119,202*PED | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | 5,047,407*PED | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | 5,047,407*PED | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | 7,119,202*PED | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | 7,119,202*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| lamivudine | Tablets | 100 mg | Epivir-HBV | 10/31/2007 |
| lamivudine | Tablets | 150 mg and 300 mg | Epivir | 10/16/2007 |
| lamivudine | Oral Solution | 10 mg/mL | Epivir | 11/22/2011 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Peru | 61699 | ► Subscribe | |||||||||||||||||||||||||||
| Indonesia | 29294 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 9204007 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1099700 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1022853 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80018 | Netherlands | ► Subscribe | PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318 | ||||||||||||||||||||||||||
| C0022 | France | ► Subscribe | PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217 | ||||||||||||||||||||||||||
| C/GB98/019 | United Kingdom | ► Subscribe | PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318 | ||||||||||||||||||||||||||
| C0020 | Belgium | ► Subscribe | PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318 | ||||||||||||||||||||||||||
| C/GB96/043 | United Kingdom | ► Subscribe | PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808 | ||||||||||||||||||||||||||
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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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