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. Odefsey's patents have been open to challenges since 06 November, 2019. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8754065 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(7 years from now) | Active |
| US9296769 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(7 years from now) | Active |
| US7125879 | HIV inhibiting pyrimidines derivatives |
Apr, 2025
(3 months from now) | Active |
| US7390791 | Prodrugs of phosphonate nucleotide analogues |
Apr, 2025
(3 months from now) | Active |
| US8080551 | HIV inhibiting pyrimidines derivatives |
Apr, 2023
(1 year, 8 months ago) |
Expired
|
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(3 years ago) |
Expired
|
| US6838464 | 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents |
Feb, 2021
(3 years ago) |
Expired
|
| US7067522 | 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents |
Dec, 2019
(5 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
|
| US5814639 | Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds |
Sep, 2015
(9 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9296769 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
|
US8754065 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
|
US7390791 (Pediatric) | Prodrugs of phosphonate nucleotide analogues |
Oct, 2025
(9 months from now) | Active |
| US8101629 | Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile |
Aug, 2022
(2 years ago) |
Expired
|
| US7803788 | Prodrugs of phosphonate nucoleotide analogues |
Feb, 2022
(2 years ago) |
Expired
|
|
US6703396 (Pediatric) | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Sep, 2021
(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
|
| US6642245 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Nov, 2020
(4 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
|
|
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
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Odefsey's patents.
Latest Legal Activities on Odefsey's Patents
Given below is the list of recent legal activities going on the following patents of Odefsey.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 22 Jan, 2024 | US8080551 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Sep, 2023 | US9296769 |
| Maintenance Fee Reminder Mailed Critical | 07 Aug, 2023 | US8080551 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jul, 2023 | US8101629 |
| Expire Patent Critical | 31 Oct, 2022 | US7803788 |
| Maintenance Fee Reminder Mailed Critical | 16 May, 2022 | US7803788 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Dec, 2021 | US8754065 |
| Withdrawal of Application for PTE Critical | 17 Jun, 2021 | US8080551 |
| Email Notification Critical | 25 Mar, 2021 | US8080551 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Mar, 2021 | US8080551 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Odefsey and ongoing litigations to help you estimate the early arrival of Odefsey generic.
Odefsey's Litigations
Odefsey been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 05, 2001, against patent number US6642245. The petitioner , challenged the validity of this patent, with DIONNE as the respondent. Click below to track the latest information on how companies are challenging Odefsey's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6703396 | April, 2002 |
Decision
(04 Apr, 2002) | DIONNE | |
| US6642245 | July, 2001 |
Decision
(05 Jul, 2001) | DIONNE | |
FDA has granted some 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-206) | Aug 21, 2020 |
| M(M-207) | Aug 21, 2020 |
| New Chemical Entity Exclusivity(NCE) | Nov 05, 2020 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 |
Alternative Brands for Odefsey
Odefsey which is used for treating HIV infection., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
| |||||||||||||
| Agouron Pharms |
| |||||||||||||
| Bristol Myers Squibb |
| |||||||||||||
| Gilead |
| |||||||||||||
| Gilead Sciences |
| |||||||||||||
| Gilead Sciences Inc |
| |||||||||||||
| Glaxosmithkline |
| |||||||||||||
| Msd Sub Merck |
| |||||||||||||
| Viiv Hlthcare |
| |||||||||||||
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.
Approval Date:
Odefsey was approved by FDA for market use on 01 March, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |