Cotellic is a drug owned by Genentech Inc. It is protected by 13 US drug patents filed from 2015 to 2023 out of which none have expired yet. Cotellic's patents will be open to challenges from 28 January, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 30, 2036. Details of Cotellic'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. | |||
| US11254649 | Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone |
Jun, 2036
(11 years from now) | Active |
| US10590102 | Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone |
Jun, 2036
(11 years from now) | Active |
| US10478400 | Immediate-release tablets containing combimetinib and methods of making and using the same |
Jun, 2036
(11 years from now) | Active |
| US7803839 | Azetidines as MEK inhibitors for the treatment of proliferative diseases |
Nov, 2029
(4 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). | |||
|
US10590102 (Pediatric) | Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone |
Dec, 2036
(12 years from now) | Active |
|
US11254649 (Pediatric) | Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone |
Dec, 2036
(12 years from now) | Active |
|
US10478400 (Pediatric) | Immediate-release tablets containing combimetinib and methods of making and using the same |
Dec, 2036
(12 years from now) | Active |
|
US11087354 (Pediatric) | Combination therapies |
Dec, 2034
(10 years from now) | Active |
| US11087354 | Combination therapies |
Jun, 2034
(9 years from now) | Active |
|
US7803839 (Pediatric) | Azetidines as MEK inhibitors for the treatment of proliferative diseases |
May, 2030
(5 years from now) | Active |
|
US8362002 (Pediatric) | Azetidines as MEK inhibitors for the treatment of proliferative diseases |
Apr, 2027
(2 years from now) | Active |
| US8362002 | Azetidines as MEK inhibitors for the treatment of proliferative diseases |
Oct, 2026
(1 year, 9 months from now) | Active |
| US11597699 | MEK inhibitors and methods of their use |
Oct, 2026
(1 year, 9 months 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 Cotellic's patents.
Latest Legal Activities on Cotellic's Patents
Given below is the list of recent legal activities going on the following patents of Cotellic.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jul, 2024 | US8362002 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Aug, 2023 | US10590102 |
| Post Issue Communication - Certificate of Correction | 16 Aug, 2023 | US11087354 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2023 | US10478400 |
| Recordation of Patent Grant Mailed Critical | 07 Mar, 2023 | US11597699 |
| Sequence Moved to Public Database | 07 Mar, 2023 | US11597699 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Mar, 2023 | US11597699 |
| Email Notification Critical | 23 Feb, 2023 | US11597699 |
| Issue Notification Mailed Critical | 15 Feb, 2023 | US11597699 |
| Dispatch to FDC | 06 Feb, 2023 | US11597699 |
FDA has granted several exclusivities to Cotellic. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cotellic, 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 Cotellic.
Exclusivity Information
Cotellic holds 7 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Cotellic's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 10, 2020 |
| Orphan Drug Exclusivity(ODE) | Nov 10, 2022 |
| Orphan Drug Exclusivity(ODE-101) | Nov 10, 2022 |
| M(M-278) | Jul 28, 2025 |
| New Indication(I-902) | Oct 28, 2025 |
| Pediatric Exclusivity(PED) | Jan 28, 2026 |
| Orphan Drug Exclusivity(ODE-416) | Oct 28, 2029 |
Several oppositions have been filed on Cotellic'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 Cotellic's generic, the next section provides detailed information on ongoing and past EP oppositions related to Cotellic patents.
Cotellic's Oppositions Filed in EPO
Cotellic has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 05, 2012, by Eip Limited. This opposition was filed on patent number EP06825554A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13753131A | Mar, 2020 | Sandoz AG | Opposition rejected |
| EP06825554A | Jan, 2012 | EIP Limited | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Cotellic 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 Cotellic's family patents as well as insights into ongoing legal events on those patents.
Cotellic's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cotellic's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 30, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cotellic Generics:
There are no approved generic versions for Cotellic as of now.
About Cotellic
Cotellic is a drug owned by Genentech Inc. It is used for the treatment of adult patients with histiocytic neoplasms and melanoma. Cotellic uses Cobimetinib Fumarate as an active ingredient. Cotellic was launched by Genentech Inc in 2015.
Approval Date:
Cotellic was approved by FDA for market use on 10 November, 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 Cotellic is 10 November, 2015, its NCE-1 date is estimated to be 28 January, 2025.
Active Ingredient:
Cotellic uses Cobimetinib Fumarate as the active ingredient. Check out other Drugs and Companies using Cobimetinib Fumarate ingredient
Treatment:
Cotellic is used for the treatment of adult patients with histiocytic neoplasms and melanoma.
Dosage:
Cotellic is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |