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Details for Patent: 6,238,695

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Patent 6,238,695 protects SUSTIVA and is included in one NDA. There has been one Paragraph IV challenge on Sustiva. There are seventeen tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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

This patent has thirty-one patent family members in twenty-six countries.

Summary for Patent: 6,238,695

Title: Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
Abstract:The present invention provides improved oral dosage form formulations of efavirenz that are useful in the inhibition of human immunodeficiency virus (HIV), the prevention or treatment of infection by HIV, and in the treatment of the resulting acquired immune deficiency syndrome (AIDS). In particular, the present invention relates to compressed tablets or capsules comprising efavirenz that contain one or more disintegrants that enhance the dissolution rate of the efavirenz in the gastrointestinal tract thereby improving the rate and extent of absorption of efavirenz in the body. The present invention also relates to the process of making such tablets or capsules.
Inventor(s): Makooi-Morehead; William T. (Wallingford, PA), Buehler; John D. (Ambler, PA), Landmann; Brian R. (Hoboken, NJ)
Assignee: DuPont Pharmaceuticals Company (Wilmington, DE)
Application Number:09/286,902
Patent Claim Types:
see list of patent claims
Dosage form; Formulation; Process; Composition; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 8th 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
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998RXNo6,238,695*PED► subscribeY
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 1998DISCNNo6,238,695*PED► subscribeY
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998RXYes6,238,695*PED► subscribeY
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Non-Orange Book Patents for Patent: 6,238,695

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
6,555,133 Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants► 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: 6,238,695

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina019031► subscribe
Austria223719► subscribe
Australia3463799► 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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