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Details for Patent: 5,935,946

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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-eight 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;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 8th 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 Sciences Inc
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYes5,935,946*PEDJan 25, 2018Y
Gilead Sciences Inc
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYes5,935,946*PEDJan 25, 2018Y
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes5,935,946*PEDJan 25, 2018Y
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International Patent Family for Patent: 5,935,946

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office0998480<subscribe>
European Patent Office1243590<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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