Olysio is a drug owned by Janssen Products Lp. It is protected by 9 US drug patents filed from 2013 to 2018 out of which none have expired yet. Olysio's patents have been open to challenges since 22 November, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 05, 2029. Details of Olysio'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. | |||
| US8148399 | Macrocyclic inhibitors of hepatitis C virus |
Sep, 2029
(4 years from now) | Active |
| US8754106 | Macrocyclic inhibitors of hepatitis C virus |
Jul, 2026
(1 year, 6 months from now) | Active |
| US8741926 | Macrocyclic inhibitors of hepatitis C virus |
Jul, 2026
(1 year, 6 months from now) | Active |
| US9040562 | Macrocyclic inhibitors of hepatitis C virus |
Jul, 2026
(1 year, 6 months from now) | Active |
| US9856265 | Macrocyclic inhibitors of hepatitis C virus |
Jul, 2026
(1 year, 6 months from now) | Active |
| US8349869 | Macrocylic inhibitors of hepatitis C virus |
Jul, 2026
(1 year, 6 months from now) | Active |
| US7671032 | HCV NS-3 serine protease inhibitors |
May, 2025
(4 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9353103 | Macrocyclic inhibitors of hepatitis C virus |
Jul, 2026
(1 year, 6 months from now) | Active |
| US9623022 | Macrocyclic inhibitors of hepatitis C virus |
Jul, 2026
(1 year, 6 months from now) | Active |
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 Olysio's patents.
Latest Legal Activities on Olysio's Patents
Given below is the list of recent legal activities going on the following patents of Olysio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 25 Jul, 2022 | US8754106 |
| Expire Patent Critical | 11 Jul, 2022 | US8741926 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jul, 2022 | US9040562 |
| Maintenance Fee Reminder Mailed Critical | 07 Feb, 2022 | US8754106 |
| Expire Patent Critical | 07 Feb, 2022 | US9856265 |
| Maintenance Fee Reminder Mailed Critical | 24 Jan, 2022 | US8741926 |
| 11.5 yr surcharge- late pmt w/in 6 mo, Small Entity | 22 Sep, 2021 | US7671032 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 22 Sep, 2021 | US7671032 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 22 Sep, 2021 | US7671032 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Sep, 2021 | US7671032 |
FDA has granted several exclusivities to Olysio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Olysio, 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 Olysio.
Exclusivity Information
Olysio holds 6 exclusivities. All of its exclusivities have expired in 2019. Details of Olysio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-697) | Nov 05, 2017 |
| New Dosing Schedule(D-151) | Oct 05, 2018 |
| New Indication(I-717) | Oct 05, 2018 |
| New Chemical Entity Exclusivity(NCE) | Nov 22, 2018 |
| M(M-171) | Feb 26, 2019 |
| M(M-179) | May 20, 2019 |
US patents provide insights into the exclusivity only within the United States, but Olysio 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 Olysio's family patents as well as insights into ongoing legal events on those patents.
Olysio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Olysio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 05, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Olysio Generics:
There are no approved generic versions for Olysio as of now.
About Olysio
Olysio is a drug owned by Janssen Products Lp. It is used for treating hepatitis C. Olysio uses Simeprevir Sodium as an active ingredient. Olysio was launched by Janssen Prods in 2013.
Approval Date:
Olysio was approved by FDA for market use on 22 November, 2013.
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 Olysio is 22 November, 2013, its NCE-1 date is estimated to be 22 November, 2017.
Active Ingredient:
Olysio uses Simeprevir Sodium as the active ingredient. Check out other Drugs and Companies using Simeprevir Sodium ingredient
Treatment:
Olysio is used for treating hepatitis C.
Dosage:
Olysio is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | CAPSULE | Discontinued | ORAL |