Cabometyx is a drug owned by Exelixis Inc. It is protected by 11 US drug patents filed from 2016 to 2022. Out of these, 10 drug patents are active and 1 has expired. Cabometyx's patents have been open to challenges since 29 November, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 17, 2037. Details of Cabometyx'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. | |||
| US8877776 | (L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide |
Oct, 2030
(5 years from now) | Active |
| US11091439 | Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, and crystalline forms therof for the treatment of cancer |
Jan, 2030
(5 years from now) | Active |
| US7579473 | c-Met modulators and methods of use |
Aug, 2026
(1 year, 8 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). | |||
| US11141413 | Method of treating renal cell carcinoma using N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate |
Apr, 2037
(12 years from now) | Active |
| US9724342 | C-met modulator pharmaceutical compositions |
Jul, 2033
(8 years from now) | Active |
| US11298349 | Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds |
Feb, 2032
(7 years from now) | Active |
| US10039757 | C-Met modulator pharmaceutical compositions |
Jul, 2031
(6 years from now) | Active |
| US10034873 | C-met modulator pharmaceutical compositions |
Jul, 2031
(6 years from now) | Active |
| US11098015 | Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, and crystalline forms thereof for the treatment of cancer |
Jan, 2030
(5 years from now) | Active |
| US11091440 | Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)- N′-(4-fluorophenyl)cyclopropane-1,1 -dicarboxamide, and crystalline forms thereof for the treatment of cancer |
Jan, 2030
(5 years from now) | Active |
| US8497284 | C-met modulators and method of use |
Sep, 2024
(a month 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 Cabometyx's patents.
Latest Legal Activities on Cabometyx's Patents
Given below is the list of recent legal activities going on the following patents of Cabometyx.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2022 | US8877776 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Apr, 2022 | US11298349 |
| Recordation of Patent Grant Mailed Critical | 12 Apr, 2022 | US11298349 |
| Email Notification Critical | 24 Mar, 2022 | US11298349 |
| Issue Notification Mailed Critical | 23 Mar, 2022 | US11298349 |
| Dispatch to FDC | 18 Mar, 2022 | US11298349 |
| Application Is Considered Ready for Issue Critical | 18 Mar, 2022 | US11298349 |
| Email Notification Critical | 10 Mar, 2022 | US11298349 |
| Mail Response to 312 Amendment (PTO-271) Critical | 10 Mar, 2022 | US11298349 |
| Response to Amendment under Rule 312 Critical | 04 Mar, 2022 | US11298349 |
FDA has granted several exclusivities to Cabometyx. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cabometyx, 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 Cabometyx.
Exclusivity Information
Cabometyx holds 8 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Cabometyx's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 29, 2017 |
| New Product(NP) | Apr 25, 2019 |
| New Indication(I-760) | Dec 19, 2020 |
| New Indication(I-792) | Jan 14, 2022 |
| New Indication(I-854) | Jan 22, 2024 |
| New Indication(I-873) | Sep 17, 2024 |
| Orphan Drug Exclusivity(ODE-227) | Jan 14, 2026 |
| Orphan Drug Exclusivity(ODE-375) | Sep 17, 2028 |
Several oppositions have been filed on Cabometyx'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 Cabometyx's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cabometyx patents.
Cabometyx's Oppositions Filed in EPO
Cabometyx has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 05, 2013, by Actavis Group Ptc Ehf. This opposition was filed on patent number EP10701175A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12704492A | Aug, 2022 | STADA Arzneimittel AG | Revoked |
| EP11740764A | Jul, 2022 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP11740764A | Jul, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP11740764A | Jul, 2022 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP10701175A | Dec, 2013 | Ladendorf, Oliver | Patent maintained as amended |
| EP10701175A | Dec, 2013 | Gallafent, Alison | Patent maintained as amended |
| EP10701175A | Dec, 2013 | Actavis Group PTC ehf | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Cabometyx 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 Cabometyx's family patents as well as insights into ongoing legal events on those patents.
Cabometyx's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cabometyx's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 17, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cabometyx Generics:
There are no approved generic versions for Cabometyx as of now.
How can I launch a generic of Cabometyx before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cabometyx's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cabometyx'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 Cabometyx -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 40 mg and 60 mg | 16 Aug, 2019 | 1 | 09 Jul, 2033 |
Alternative Brands for Cabometyx
Cabometyx which is used for treating advanced renal cell carcinoma, differentiated thyroid cancer, and hepatocellular carcinoma., has several other brand drugs in the same treatment category and using the same active ingredient (Cabozantinib S-malate). 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 | ||
|---|---|---|---|---|
| Bayer Hlthcare |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Cabozantinib S-malate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Exelixis |
|
About Cabometyx
Cabometyx is a drug owned by Exelixis Inc. It is used for treating advanced renal cell carcinoma, differentiated thyroid cancer, and hepatocellular carcinoma. Cabometyx uses Cabozantinib S-Malate as an active ingredient. Cabometyx was launched by Exelixis Inc in 2016.
Can you believe Cabometyx received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Cabometyx was approved by FDA for market use on 25 April, 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 Cabometyx is 25 April, 2016, its NCE-1 date is estimated to be 29 November, 2016.
Active Ingredient:
Cabometyx uses Cabozantinib S-malate as the active ingredient. Check out other Drugs and Companies using Cabozantinib S-malate ingredient
Treatment:
Cabometyx is used for treating advanced renal cell carcinoma, differentiated thyroid cancer, and hepatocellular carcinoma.
Dosage:
Cabometyx is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | TABLET | Prescription | ORAL |
| EQ 60MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |