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Generated: April 26, 2017

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Details for Patent: 5,935,946

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Which drugs does patent 5,935,946 protect, and when does it expire?

Patent 5,935,946 protects STRIBILD, COMPLERA, ATRIPLA, TRUVADA, and VIREAD, and is included in six NDAs. There have been zero Paragraph IV challenges on Complera, Viread, , and Atripla. There are nineteen tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for STRIBILD has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 5,935,946

Title: Nucleotide analog composition and synthesis method
Abstract:The invention provides a composition comprising bis(POC)PMPA and fumaric acid (1:1). The composition is useful as an intermediate for the preparation of antiviral compounds, or is useful for administration to patients for antiviral therapy or prophylaxis. The composition is particularly useful when administered orally. The invention also provides methods to make PMPA and intermediates in PMPA synthesis. Embodiments include lithium t-butoxide, 9-(2-hydroxypropyl) adenine and diethyl p-toluenesulfonylmethoxyphosphonate in an organic solvent such as DMF. The reaction results in diethyl PMPA preparations containing an improved by-product profile compared to diethyl PMPA made by prior methods.
Inventor(s): Munger, Jr.; John D. (Alviso, CA), Rohloff; John C. (Mountain View, CA), Schultze; Lisa M. (San Carlos, CA)
Assignee: Gilead Sciences, Inc. (Foster City, CA)
Application Number:08/900,752
Patent Claim Types:
see list of patent claims
Composition; Compound; Formulation; Use; Dosage form; Process;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Gilead Sciences Inc
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes5,935,946*PED► SubscribeY
Gilead Sciences Inc
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes5,935,946*PED► SubscribeY
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes5,935,946*PED► SubscribeY
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-002Mar 10, 2016RXYesNo5,935,946*PED► SubscribeY
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-003Mar 10, 2016RXYesNo5,935,946*PED► SubscribeY
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International Patent Family for Patent: 5,935,946

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
South Korea100617608► Subscribe
South Korea20060038452► Subscribe
Japan2015199773► Subscribe
Japan2013213071► Subscribe
Japan5398662► 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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