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Generated: July 24, 2017
What is the competitive landscape for VIIV HLTHCARE, and when can generic versions of VIIV HLTHCARE drugs launch?
VIIV HLTHCARE has eighteen approved drugs.| Patents: | 14 |
| Tradenames: | 11 |
| Ingredients: | 11 |
| NDAs: | 18 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790-002 | Jun 9, 2016 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Viiv Hlthcare | SELZENTRY | maraviroc | SOLUTION;ORAL | 208984-001 | Nov 4, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Viiv Hlthcare | TRIUMEQ | abacavir sulfate; dolutegravir sodium; lamivudine | TABLET;ORAL | 205551-001 | Aug 22, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Viiv Hlthcare | SELZENTRY | maraviroc | SOLUTION;ORAL | 208984-001 | Nov 4, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Viiv Hlthcare | TRIZIVIR | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 021205-001 | Nov 14, 2000 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | COMBIVIR | lamivudine; zidovudine | TABLET;ORAL | 020857-001 | Sep 26, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | RETROVIR | zidovudine | TABLET;ORAL | 020518-002 | Oct 4, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | EPZICOM | abacavir sulfate; lamivudine | TABLET;ORAL | 021652-001 | Aug 2, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | TRIZIVIR | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 021205-001 | Nov 14, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Viiv Hlthcare | TRIZIVIR | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 021205-001 | Nov 14, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
abacavir | Oral Solution | 20 mg/ml | ZIAGEN | 12/27/2012 |
fosamprenavir calcium | Tablets | 700 mg | LEXIVA | 1/18/2012 |
lamivudine | Oral Solution | 10 mg/mL | EPIVIR | 11/22/2011 |
maraviroc | Tablets | 150 mg and 300 mg | SELZENTRY | 8/8/2011 |
abacavir sulfate, lamivudine and zidovudine | Tablets | 300 mg/150 mg/300 mg | TRIZIVIR | 3/22/2011 |
abacavir sulfate | Tablets | 300 mg | ZIAGEN | 1/28/2009 |
lamivudine | Tablets | 150 mg and 300 mg | EPIVIR | 10/16/2007 |
abacavir sulfate and lamivudine | Tablets | 600 mg/300 mg | EPZICOM | 9/27/2007 |
lamivudine and zidovudine | Tablets | 150 mg/300 mg | COMBIVIR | 6/26/2007 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,586,431 | 3,3-Biarylpiperidine and 2,2-biarylmorpholine derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 9,051,337 | Substituted 10-hydroxy-9,11-dioxo-2,3,4a,5,9,11,13,13a-octahydro-1h-pyrido[1,2-a]pyrr- olo[1',2':3,4]imidazo[1,2-d]pyrazine-8-carboxamides | ► Subscribe | |||||||||||||||||||||||||||
| 8,410,103 | (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent | ► Subscribe | |||||||||||||||||||||||||||
| 7,108,864 | Tablet formation | ► Subscribe | |||||||||||||||||||||||||||
| 9,273,065 | Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Slovenia | 0969815 | ► Subscribe | |||||||||||||||||||||||||||
| Cyprus | 1116331 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 228754 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 324731 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 225600 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2008 | Austria | ► Subscribe | PRODUCT NAME: MARAVIROC, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918 | ||||||||||||||||||||||||||
| 2005 00028 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 2014021 | Lithuania | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116 | ||||||||||||||||||||||||||
| /2008 | Austria | ► Subscribe | PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713 | ||||||||||||||||||||||||||
| 2014 00032 | Denmark | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121 | ||||||||||||||||||||||||||
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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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