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Details for Patent: 9,018,192

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Patent 9,018,192 protects ATRIPLA and is included in one NDA. There has been one Paragraph IV challenge on Atripla. There are five tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has forty-six patent family members in twenty-six countries.

Summary for Patent: 9,018,192

Title:Unitary pharmaceutical dosage form
Abstract: In accordance with this invention a novel pharmaceutical product containing efavirenz, emtricitabine and tenofovir DF are provided as a multicomponent unitary oral dosage form, component 1 comprising tenofovir DF (and, optionally, emtricitabine) and component 2 comprising efavirenz, wherein components 1 and 2 are in a stabilizing configuration. In preferred embodiments component 1 is made by dry granulation.
Inventor(s): Dahl; Terrence C. (Sunnyvale, CA), Hussain; Munir A. (Belle Mead, NJ), Lipper; Robert A. (Pennington, NJ), Jerzewski; Robert L. (Belle Mead, NJ), Menning; Mark M. (San Francisco, CA), Oliyai; Reza (San Carlos, CA), Yang; Taiyin (Saratoga, CA)
Assignee: Bristol-Myers Squibb & Gilead Sciences, Inc. (Foster City, CA)
Application Number:14/050,714
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 123rd percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes9,018,192► subscribe TREATMENT OF HIV-1 INFECTION IN ADULTS
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes9,018,192► subscribe TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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Non-Orange Book Patents for Patent: 9,018,192

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
8,871,271Method and composition for pharmaceutical product► subscribe
8,598,185Unitary pharmaceutical dosage form► 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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International Patent Family for Patent: 9,018,192

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Ukraine108594► subscribe
TaiwanI471145► subscribe
TaiwanI375560► 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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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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