DrugPatentWatch Database Preview
COTELLIC Drug Profile
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Which patents cover Cotellic, and what generic alternatives are available?
Cotellic is a drug marketed by Genentech Inc and is included in one NDA. There are four patents protecting this drug.
This drug has ninety patent family members in forty countries.
The generic ingredient in COTELLIC is cobimetinib fumarate. One supplier is listed for this compound. Additional details are available on the cobimetinib fumarate profile page.
US ANDA Litigation and Generic Entry Outlook for Cotellic
Cotellic was eligible for patent challenges on November 10, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 30, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for COTELLIC
| International Patents: | 90 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 16 |
| Patent Applications: | 92 |
| Drug Prices: | Drug price information for COTELLIC |
| DailyMed Link: | COTELLIC at DailyMed |
Generic Entry Opportunity Date for COTELLIC
Generic Entry Date for COTELLIC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for COTELLIC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Uppsala University Hospital | Phase 2 |
| Texas Children's Hospital | Phase 2 |
| Carl Allen | Phase 2 |
Pharmacology for COTELLIC
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors |
US Patents and Regulatory Information for COTELLIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192-001 | Nov 10, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192-001 | Nov 10, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Genentech Inc | COTELLIC | cobimetinib fumarate | TABLET;ORAL | 206192-001 | Nov 10, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for COTELLIC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 104892582 | Start Trial |
| Mexico | 2017016163 | Start Trial |
| Israel | 189900 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for COTELLIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1934174 | 2016/022 | Ireland | Start Trial | PRODUCT NAME: COBIMETINIB, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES, IN PARTICULAR COBIMETINIB HEMIFUMARATE.; REGISTRATION NO/DATE: EU/1/15/1048/001 20151120 |
| 1934174 | 22/2016 | Austria | Start Trial | PRODUCT NAME: COBIMETINIB ALS EIN EINZELNES STEREOISOMER ODER ALS EINE MISCHUNG VON STEROISOMEREN DAVON, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE UND SOLVATE, INSBESONDERE COMBIMETINIB HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 (MITTEILUNG) 20151124 |
| 1934174 | C20160012 00193 | Estonia | Start Trial | PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
