Cometriq is a drug owned by Exelixis Inc. It is protected by 7 US drug patents filed from 2013 to 2022 out of which none have expired yet. Cometriq'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 Feb 10, 2032. Details of Cometriq'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). | |||
| US11298349 | Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds |
Feb, 2032
(7 years from now) | Active |
| US9717720 | Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds |
Feb, 2032
(7 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 |
| 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 |
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 Cometriq's patents.
Latest Legal Activities on Cometriq's Patents
Given below is the list of recent legal activities going on the following patents of Cometriq.
| 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 |
| Application Is Considered Ready for Issue Critical | 18 Mar, 2022 | US11298349 |
| Dispatch to FDC | 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 Cometriq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cometriq, 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 Cometriq.
Exclusivity Information
Cometriq holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Cometriq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 29, 2017 |
| Orphan Drug Exclusivity(ODE) | Nov 29, 2019 |
| Orphan Drug Exclusivity(ODE-33) | Nov 29, 2019 |
Several oppositions have been filed on Cometriq'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 Cometriq's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cometriq patents.
Cometriq's Oppositions Filed in EPO
Cometriq 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 |
| 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 Cometriq 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 Cometriq's family patents as well as insights into ongoing legal events on those patents.
Cometriq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cometriq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 10, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cometriq Generics:
There are no approved generic versions for Cometriq as of now.
Alternative Brands for Cometriq
Cometriq which is used for treating medullary thyroid cancer., has several other brand drugs 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 | |
|---|---|---|
| Exelixis Inc |
|
About Cometriq
Cometriq is a drug owned by Exelixis Inc. It is used for treating medullary thyroid cancer. Cometriq uses Cabozantinib S-Malate as an active ingredient. Cometriq was launched by Exelixis in 2012.
Can you believe Cometriq 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:
Cometriq was approved by FDA for market use on 29 November, 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 Cometriq is 29 November, 2012, its NCE-1 date is estimated to be 29 November, 2016.
Active Ingredient:
Cometriq uses Cabozantinib S-malate as the active ingredient. Check out other Drugs and Companies using Cabozantinib S-malate ingredient
Treatment:
Cometriq is used for treating medullary thyroid cancer.
Dosage:
Cometriq is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | CAPSULE | Prescription | ORAL |
| EQ 80MG BASE | CAPSULE | Prescription | ORAL |