Stivarga is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2013 to 2018. Out of these, 4 drug patents are active and 1 has expired. Stivarga's patents have been open to challenges since 27 September, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 09, 2032. Details of Stivarga'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. | |||
| US9957232 | 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate |
Jul, 2032
(7 years from now) | Active |
| US8637553 | Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions |
Feb, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9458107 | Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-ethylpyridie-carboxamide, its salts and monohydrate |
Apr, 2031
(6 years from now) | Active |
| US8680124 | Treatment of cancers with acquired resistance to kit inhibitors |
Jun, 2030
(5 years from now) | Active |
| US7351834 | ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors |
Jan, 2020
(4 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 Stivarga's patents.
Latest Legal Activities on Stivarga's Patents
Given below is the list of recent legal activities going on the following patents of Stivarga.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Mar, 2024 | US9458107 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Oct, 2021 | US9957232 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Jul, 2021 | US8637553 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Mar, 2020 | US9458107 |
| Patent Issue Date Used in PTA Calculation Critical | 01 May, 2018 | US9957232 |
| Recordation of Patent Grant Mailed Critical | 01 May, 2018 | US9957232 |
| Email Notification Critical | 12 Apr, 2018 | US9957232 |
| Issue Notification Mailed Critical | 11 Apr, 2018 | US9957232 |
| Pubs Case Remand to TC Critical | 27 Mar, 2018 | US9957232 |
| Printer Rush- No mailing | 27 Mar, 2018 | US9957232 |
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 Stivarga and ongoing litigations to help you estimate the early arrival of Stivarga generic.
Stivarga's Litigations
Stivarga been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 25, 2016, against patent number US8637553. The petitioner Fustibal LLC, challenged the validity of this patent, with Bayer HealthCare LLC as the respondent. Click below to track the latest information on how companies are challenging Stivarga's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9957232 | November, 2015 |
Decision
(14 Feb, 2017) | Alfons Grunenberg et al | |
| US8637553 | July, 2016 |
Terminated-Denied
(08 Feb, 2017) | Bayer HealthCare LLC | Fustibal LLC |
FDA has granted some exclusivities to Stivarga. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Stivarga, 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 Stivarga.
Exclusivity Information
Stivarga holds 6 exclusivities. All of its exclusivities have expired in 2024. Details of Stivarga's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-667) | Feb 25, 2016 |
| New Chemical Entity Exclusivity(NCE) | Sep 27, 2017 |
| Orphan Drug Exclusivity(ODE) | Feb 25, 2020 |
| Orphan Drug Exclusivity(ODE-44) | Feb 25, 2020 |
| New Indication(I-744) | Apr 27, 2020 |
| Orphan Drug Exclusivity(ODE-139) | Apr 27, 2024 |
Several oppositions have been filed on Stivarga'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 Stivarga's generic, the next section provides detailed information on ongoing and past EP oppositions related to Stivarga patents.
Stivarga's Oppositions Filed in EPO
Stivarga has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 18, 2014, by Fresenius Kabi Deutschland Gmbh. This opposition was filed on patent number EP07818583A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP07818583A | Mar, 2014 | Fresenius Kabi Deutschland GmbH | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Stivarga 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 Stivarga's family patents as well as insights into ongoing legal events on those patents.
Stivarga's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Stivarga's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 09, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Stivarga Generics:
There are no approved generic versions for Stivarga as of now.
How can I launch a generic of Stivarga before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Stivarga's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Stivarga'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 Stivarga -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg | 27 Sep, 2016 | 2 | 16 Feb, 2031 |
About Stivarga
Stivarga is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating gastrointestinal stromal tumors (GIST) in patients, including those who have previously been treated with imatinib and those with resistance to a KIT tyrosine kinase inhibitor. Stivarga uses Regorafenib as an active ingredient. Stivarga was launched by Bayer Hlthcare in 2012.
Approval Date:
Stivarga was approved by FDA for market use on 27 September, 2012.
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 Stivarga is 27 September, 2012, its NCE-1 date is estimated to be 27 September, 2016.
Active Ingredient:
Stivarga uses Regorafenib as the active ingredient. Check out other Drugs and Companies using Regorafenib ingredient
Treatment:
Stivarga is used for treating gastrointestinal stromal tumors (GIST) in patients, including those who have previously been treated with imatinib and those with resistance to a KIT tyrosine kinase inhibitor.
Dosage:
Stivarga is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG | TABLET | Prescription | ORAL |