Nexavar is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 10, 2028. Details of Nexavar'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. | |||
| US8877933 | Thermodynamically stable form of a tosylate salt |
Dec, 2027
(3 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). | |||
| US9737488 | Pharmaceutical composition for the treatment of cancer |
Sep, 2028
(3 years from now) | Active |
| US8618141 | Aryl ureas with angiogenesis inhibiting activity |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
| US8124630 | ω-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors |
Jan, 2020
(4 years ago) |
Expired
|
| US7235576 | Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors |
Jan, 2020
(4 years ago) |
Expired
|
| US7351834 | ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors |
Jan, 2020
(4 years ago) |
Expired
|
| US8841330 | Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors |
Jan, 2020
(4 years ago) |
Expired
|
| US7897623 | ω-carboxyl aryl substituted diphenyl ureas as p38 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 Nexavar's patents.
Latest Legal Activities on Nexavar's Patents
Given below is the list of recent legal activities going on the following patents of Nexavar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 01 Apr, 2024 | US8124630 |
| Maintenance Fee Reminder Mailed Critical | 16 Oct, 2023 | US8124630 |
| Expire Patent Critical | 03 Apr, 2023 | US7897623 (Litigated) |
| Expire Patent Critical | 31 Oct, 2022 | US8841330 |
| Maintenance Fee Reminder Mailed Critical | 17 Oct, 2022 | US7897623 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 16 May, 2022 | US8841330 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2022 | US8877933 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jun, 2021 | US8618141 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Sep, 2020 | US9737488 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2019 | US7351834 (Litigated) |
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 Nexavar and ongoing litigations to help you estimate the early arrival of Nexavar generic.
Nexavar's Litigations
Nexavar been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 17, 2005, against patent number US8124630. The petitioner , challenged the validity of this patent, with Bernd Riedl et al as the respondent. Click below to track the latest information on how companies are challenging Nexavar's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8124630 | June, 2005 |
Decision
(27 Dec, 2005) | Bernd Riedl et al | |
FDA has granted some exclusivities to Nexavar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nexavar, 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 Nexavar.
Exclusivity Information
Nexavar holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Nexavar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Dec 20, 2012 |
| New Indication(I-677) | Nov 22, 2016 |
| Orphan Drug Exclusivity(ODE-56) | Nov 22, 2020 |
Several oppositions have been filed on Nexavar'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 Nexavar's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nexavar patents.
Nexavar's Oppositions Filed in EPO
Nexavar has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 29, 2011, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP06707141A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP03707846A | Apr, 2014 | Accord Healthcare Ltd | Revoked |
| EP03707846A | Apr, 2014 | Hetero Drugs Ltd. | Revoked |
| EP05797740A | Mar, 2013 | Biofer S.p.A. | Revoked |
| EP05797740A | Mar, 2013 | Fresenius Kabi Deutschland GmbH | Revoked |
| EP06707141A | Jun, 2011 | Altmann, Andreas | Revoked |
| EP06707141A | Jun, 2011 | Teva Pharmaceutical Industries Ltd. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Nexavar 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 Nexavar's family patents as well as insights into ongoing legal events on those patents.
Nexavar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nexavar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 10, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nexavar Generic API suppliers:
Sorafenib Tosylate is the generic name for the brand Nexavar. 5 different companies have already filed for the generic of Nexavar, with Dr Reddys having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nexavar's generic
How can I launch a generic of Nexavar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nexavar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nexavar'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 Nexavar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg | 28 Feb, 2014 | 1 | 10 Sep, 2020 | 11 Feb, 2023 | Eligible |
Alternative Brands for Nexavar
Nexavar which is used for treating advanced renal cell carcinoma, carcinoma of the thyroid, and unresectable hepatocellular carcinoma., 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 | ||
|---|---|---|---|---|
| Exelixis Inc |
| |||
About Nexavar
Nexavar is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating advanced renal cell carcinoma, carcinoma of the thyroid, and unresectable hepatocellular carcinoma. Nexavar uses Sorafenib Tosylate as an active ingredient. Nexavar was launched by Bayer Hlthcare in 2005.
Approval Date:
Nexavar was approved by FDA for market use on 20 December, 2005.
Active Ingredient:
Nexavar uses Sorafenib Tosylate as the active ingredient. Check out other Drugs and Companies using Sorafenib Tosylate ingredient
Treatment:
Nexavar is used for treating advanced renal cell carcinoma, carcinoma of the thyroid, and unresectable hepatocellular carcinoma.
Dosage:
Nexavar is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | TABLET | Prescription | ORAL |