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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,642,245

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Which drugs does patent 6,642,245 protect, and when does it expire?


Patent 6,642,245 protects EMTRIVA, ATRIPLA, COMPLERA, DESCOVY, GENVOYA, ODEFSEY, STRIBILD, and TRUVADA, and is included in nine NDAs. There have been zero Paragraph IV challenges on Emtriva, Truvada, Complera, and Atripla.

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

This patent has one hundred and seventy patent family members in thirty-four countries.

Summary for Patent: 6,642,245

Title: Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Abstract:A method and composition for the treatment of HIV and HBV infections in humans is disclosed that includes administering an effective amount of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, a pharmaceutically acceptable derivative thereof, including a 5' or N.sup.4 alkylated or acylated derivative, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier. A process for the resolution of a racemic mixture of nucleoside enantiomers is also disclosed that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers.
Inventor(s): Liotta; Dennis C. (Stone Mountain, GA), Schinazi; Raymond F. (Decatur, GA), Choi; Woo-Baeg (North Brunswick, NJ)
Assignee: Emory University (Atlanta, GA)
Application Number:08/475,339
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
GileadEMTRIVAemtricitabineCAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► Subscribe► SubscribeY
GileadEMTRIVAemtricitabineSOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeY
GileadATRIPLAefavirenz; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► Subscribe► SubscribeY
Gilead Sciences IncCOMPLERAemtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarateTABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► Subscribe► SubscribeY
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► Subscribe► SubscribeY
Gilead Sciences IncGENVOYAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarateTABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► Subscribe► SubscribeY
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► Subscribe► SubscribeY
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-002Mar 10, 2016RXYesNo► Subscribe► Subscribe► SubscribeY
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-003Mar 10, 2016RXYesNo► Subscribe► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,642,245

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
6,931,679 Foldable stand for a hammock► Subscribe
6,703,396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,812,233 Therapeutic nucleosides► 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: 6,642,245

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria170750► Subscribe
Austria219366► Subscribe
Austria270291► Subscribe
Austria361293► Subscribe
Austria469147► Subscribe
Australia1367692► Subscribe
Australia1437292► Subscribe
Australia1561792► Subscribe
Australia2002300661► Subscribe
Australia2006207874► 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Queensland Health
Johnson and Johnson
Colorcon
Healthtrust
Covington
Argus Health
Deloitte
QuintilesIMS

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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