Savaysa is a drug owned by Daiichi Sankyo Inc. It is protected by 2 US drug patents filed in 2015 out of which none have expired yet. Savaysa's patents have been open to challenges since 08 January, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 28, 2028. Details of Savaysa'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. | |||
| US7365205 | Diamine derivatives |
Apr, 2027
(1 year, 9 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). | |||
| US9149532 | Pharmaceutical composition |
Mar, 2028
(2 years 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 Savaysa's patents.
Latest Legal Activities on Savaysa's Patents
Given below is the list of recent legal activities going on the following patents of Savaysa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Mar, 2023 | US9149532 |
| Change in Power of Attorney (May Include Associate POA) Critical | 19 Mar, 2021 | US7365205 |
| Email Notification Critical | 19 Mar, 2021 | US7365205 |
| Patent Term Extension Certificate Critical | 16 Feb, 2021 | US7365205 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 Feb, 2021 | US9149532 |
| Email Notification Critical | 03 Feb, 2021 | US9149532 |
| Correspondence Address Change Critical | 01 Feb, 2021 | US9149532 |
| Correspondence Address Change Critical | 05 Jan, 2021 | US7365205 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Oct, 2019 | US7365205 |
| Notice of Final Determination -Eligible | 19 Sep, 2019 | US7365205 |
FDA has granted several exclusivities to Savaysa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Savaysa, 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 Savaysa.
Exclusivity Information
Savaysa holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Savaysa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 08, 2020 |
| M(M-243) | Aug 09, 2022 |
| M(M-14) | Oct 18, 2026 |
Several oppositions have been filed on Savaysa'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 Savaysa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Savaysa patents.
Savaysa's Oppositions Filed in EPO
Savaysa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 01, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP02743653A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08720658A | May, 2018 | Hexal AG | Granted and Under Opposition |
| EP08720658A | May, 2018 | Generics [UK] Ltd | Granted and Under Opposition |
| EP02743653A | May, 2013 | Generics [UK] Limited | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Savaysa 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 Savaysa's family patents as well as insights into ongoing legal events on those patents.
Savaysa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Savaysa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 28, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Savaysa Generics:
There are no approved generic versions for Savaysa as of now.
How can I launch a generic of Savaysa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Savaysa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Savaysa'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 Savaysa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg, 30 mg and 60 mg | 28 Jan, 2019 | 1 | 28 Mar, 2028 |
About Savaysa
Savaysa is a drug owned by Daiichi Sankyo Inc. Savaysa uses Edoxaban Tosylate as an active ingredient. Savaysa was launched by Daiichi Sankyo Inc in 2015.
Approval Date:
Savaysa was approved by FDA for market use on 08 January, 2015.
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 Savaysa is 08 January, 2015, its NCE-1 date is estimated to be 08 January, 2019.
Active Ingredient:
Savaysa uses Edoxaban Tosylate as the active ingredient. Check out other Drugs and Companies using Edoxaban Tosylate ingredient
Dosage:
Savaysa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 60MG BASE | TABLET | Prescription | ORAL |
| EQ 30MG BASE | TABLET | Prescription | ORAL |
| EQ 15MG BASE | TABLET | Prescription | ORAL |