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Generated: August 23, 2017
What is the competitive landscape for JANSSEN R AND D, and when can generic versions of JANSSEN R AND D drugs launch?
JANSSEN R AND D has two approved drugs.| Patents: | 4 |
| Tradenames: | 2 |
| Ingredients: | 2 |
| NDAs: | 2 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,530,655 | HIV replication inhibiting pyrimidines | ► Subscribe | |||||||||||||||||||||||||||
| 7,241,458 | Antiviral compositions | ► Subscribe | |||||||||||||||||||||||||||
| 6,638,932 | 2,4-disubstituted triazine derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 7,015,221 | 2,4-disubstituted triazine derivatives | ► 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 | 1002795 | ► Subscribe | |||||||||||||||||||||||||||
| Iceland | 6256 | ► Subscribe | |||||||||||||||||||||||||||
| Ukraine | 74797 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 315031 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 318801 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1002795/01 | Switzerland | ► Subscribe | PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008 | ||||||||||||||||||||||||||
| 2009 00004 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 0373 | Netherlands | ► Subscribe | 300373, 20191101, EXPIRES: 20230827 | ||||||||||||||||||||||||||
| 2009000003 | Germany | ► Subscribe | PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE; REGISTRATION NO/DATE: EU/1/08/468/001 20080828 | ||||||||||||||||||||||||||
| C/GB09/003 | United Kingdom | ► Subscribe | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/003 GRANTED TO JANSSEN PHARMACEUTICA NV IN RESPECT OF THE PRODUCT ETRAVIRINE OPTIONALLY IN A FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6342 DATED 08 DECEMBER 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 AUGUST 2023. | ||||||||||||||||||||||||||
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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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