LAZERTINIB MESYLATE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for lazertinib mesylate and what is the scope of freedom to operate?
Lazertinib mesylate
is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lazertinib mesylate has one hundred and one patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for LAZERTINIB MESYLATE
| International Patents: | 101 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | LAZERTINIB MESYLATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LAZERTINIB MESYLATE
Generic Entry Date for LAZERTINIB MESYLATE*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Anatomical Therapeutic Chemical (ATC) Classes for LAZERTINIB MESYLATE
US Patents and Regulatory Information for LAZERTINIB MESYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Biotech | LAZCLUZE | lazertinib mesylate | TABLET;ORAL | 219008-002 | Aug 19, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Biotech | LAZCLUZE | lazertinib mesylate | TABLET;ORAL | 219008-001 | Aug 19, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Biotech | LAZCLUZE | lazertinib mesylate | TABLET;ORAL | 219008-002 | Aug 19, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 LAZERTINIB MESYLATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 106795144 | 用于调节EGFR突变体激酶活性的化合物和组合物 (Compounds and compositions for modulating EGFR mutant kinase activities) | ⤷ Sign Up |
| Lithuania | 3604294 | ⤷ Sign Up | |
| South Africa | 201907687 | SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
