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McKinsey
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for Patent: 5,914,331

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Which drugs does patent 5,914,331 protect, and when does it expire?


Patent 5,914,331 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: 5,914,331

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:08/488,097
Patent Claim Types:
see list of patent claims
Compound; Composition;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
GileadEMTRIVAemtricitabineCAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
GileadEMTRIVAemtricitabineSOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
GileadATRIPLAefavirenz; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncCOMPLERAemtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarateTABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncDESCOVYemtricitabine; tenofovir alafenamide fumarateTABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncGENVOYAcobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarateTABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncODEFSEYemtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarateTABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-002Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-003Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Patent: 5,914,331

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
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► 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: 5,914,331

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Israel100965► Subscribe
Israel101144► Subscribe
Canada2481078► Subscribe
Canada2513440► Subscribe
Canada2678778► Subscribe
China1065065► Subscribe
China1037682► Subscribe
China1203232► Subscribe
China1084745► Subscribe
China1127301► 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:

Fish and Richardson
Covington
Federal Trade Commission
Teva
Express Scripts
Cantor Fitzgerald
Citi
Johnson and Johnson
Merck
Colorcon

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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