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Details for Patent: 6,639,071

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Patent 6,639,071 protects ATRIPLA and SUSTIVA and is included in three NDAs. There have been zero Paragraph IV challenges on Sustiva and Atripla There are twenty-two tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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

This patent has thirty-seven patent family members in nineteen countries.

Summary for Patent: 6,639,071

Title: Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-ben zoxazin-2-one
Abstract:The instant invention describes a method for crystallizing (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-ben zoxazin-2-one from a solvent and anti-solvent system and producing the crystalline product. The desired final crystal form, Form I, can be produced when using methanol or ethanol. Form II is isolated from 2-propanol and can be converted to the desired crystal form at low drying temperatures, such as between about a temperature of 40.degree. C. and 50.degree. C.
Inventor(s): Crocker; Louis S. (Belle Mead, NJ), Kukura, II; Joseph L. (Somerset, NJ), Thompson; Andrew S. (Mountainside, NJ), Stelmach; Christine (Westfield, NJ), Young; Steven D. (Lansdale, PA)
Assignee: Merck & Co., Inc. (Rahway, NJ)
Application Number:10/000,537
Patent Claim Types:
see list of patent claims
Compound;
Patent Metrics:
Source: PatentQuant.com
Field: Organic fine chemistry
Back Citations: 12th percentile
Forward Citations: 1st 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, 2006RXYes6,639,071*PED► subscribeY
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 2002DISCNNo6,639,071*PED► subscribeY
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 2002RXYes6,639,071*PED► subscribeY
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Non-Orange Book Patents for Patent: 6,639,071

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
6,939,964 Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-ben zoxazin-2-one► subscribe
5,965,729 Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent► 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: 6,639,071

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria486065► subscribe
Australia6263298► subscribe
Australia738545► 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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