Odefsey Patent Expiration

Odefsey is a drug owned by Gilead Sciences Inc. It is protected by 20 US drug patents filed from 2016 to 2021. Out of these, 7 drug patents are active and 13 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 15, 2033. Details of Odefsey's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5814639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds
Sep, 2015

(8 years ago)

Expired
US5914331 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Jul, 2017

(7 years ago)

Expired
US7067522 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents
Dec, 2019

(4 years ago)

Expired
US6838464 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents
Feb, 2021

(3 years ago)

Expired
US6703396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Mar, 2021

(3 years ago)

Expired
US8080551 HIV inhibiting pyrimidines derivatives
Apr, 2023

(1 year, 3 months ago)

Expired
US7390791 Prodrugs of phosphonate nucleotide analogues
Apr, 2025

(8 months from now)

Active
US7125879 HIV inhibiting pyrimidines derivatives
Apr, 2025

(9 months from now)

Active
US9296769 Tenofovir alafenamide hemifumarate
Aug, 2032

(8 years from now)

Active
US8754065 Tenofovir alafenamide hemifumarate
Aug, 2032

(8 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5814639

(Pediatric)

Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds
Mar, 2016

(8 years ago)

Expired
US5914331

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Jan, 2018

(6 years ago)

Expired
US6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Nov, 2020

(3 years ago)

Expired
US6642245

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
May, 2021

(3 years ago)

Expired
US6703396

(Pediatric)

Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Sep, 2021

(2 years ago)

Expired
US7803788 Prodrugs of phosphonate nucoleotide analogues
Feb, 2022

(2 years ago)

Expired
US8101629 Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile
Aug, 2022

(1 year, 11 months ago)

Expired
US7390791

(Pediatric)

Prodrugs of phosphonate nucleotide analogues
Oct, 2025

(1 year, 2 months from now)

Active
US8754065

(Pediatric)

Tenofovir alafenamide hemifumarate
Feb, 2033

(8 years from now)

Active
US9296769

(Pediatric)

Tenofovir alafenamide hemifumarate
Feb, 2033

(8 years from now)

Active


FDA has granted several exclusivities to Odefsey. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Odefsey, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Odefsey.

Exclusivity Information

Odefsey holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Odefsey's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-207) Aug 21, 2020
M(M-206) Aug 21, 2020
New Chemical Entity Exclusivity(NCE) Nov 05, 2020

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Several oppositions have been filed on Odefsey's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Odefsey's generic, the next section provides detailed information on ongoing and past EP oppositions related to Odefsey patents.

Odefsey's oppositions filed in EPO

Odefsey has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 09, 2012, by Hamm, Volker. This opposition was filed on patent number EP05108086A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP13164300A Jan, 2018 Georg Kalhammer/Stephan Teipel Granted and Under Opposition
EP13164300A Jan, 2018 Aechter, Bernd Granted and Under Opposition
EP13164300A Jan, 2018 Cooke, Richard Granted and Under Opposition
EP12753867A Jul, 2017 FRKelly Granted and Under Opposition
EP12753867A Jul, 2017 Sandoz GmbH Granted and Under Opposition
EP12753867A Jul, 2017 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP04787096A Jan, 2016 Page White & Farrer Limited Patent maintained as amended
EP01961695A Nov, 2015 HEXAL PHARMA AG Patent maintained as amended
EP01961695A Nov, 2015 Strawman Limited Patent maintained as amended
EP01961695A Nov, 2015 Swindell & Pearson Limited Patent maintained as amended
EP01961695A Nov, 2015 Teva Pharmaceutical Industries Ltd Patent maintained as amended
EP05108086A Feb, 2012 Hamm, Volker The patent has been limited


US patents provide insights into the exclusivity only within the United States, but Odefsey is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Odefsey's family patents as well as insights into ongoing legal events on those patents.

Odefsey's family patents

Odefsey has patent protection in a total of 58 countries. It's US patent count contributes only to 13.5% of its total global patent coverage. 13 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Odefsey.

Family Patents

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Generic Launch

Generic Release Date:

Odefsey's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Odefsey Generics:

There are no approved generic versions for Odefsey as of now.

How can I launch a generic of Odefsey before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Odefsey's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Odefsey's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Odefsey -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
200 mg/25 mg/ 25 mg 05 Nov, 2019 3 15 Aug, 2032




About Odefsey

Odefsey is a drug owned by Gilead Sciences Inc. It is used for treating HIV infection. Odefsey uses Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate as an active ingredient. Odefsey was launched by Gilead Sciences Inc in 2016.

Market Authorisation Date:

Odefsey was approved by FDA for market use on 01 March, 2016.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Odefsey is 01 March, 2016, its NCE-1 date is estimated to be 06 November, 2019

Active Ingredient:

Odefsey uses Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate as the active ingredient. Check out other Drugs and Companies using Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate ingredient

Treatment:

Odefsey is used for treating HIV infection.

Dosage:

Odefsey is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG;EQ 25MG BASE;EQ 25MG BASE TABLET Prescription ORAL