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OSIMERTINIB MESYLATE - Generic Drug Details
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What are the generic drug sources for osimertinib mesylate and what is the scope of freedom to operate?
Osimertinib mesylate
is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Osimertinib mesylate has one hundred and forty patent family members in forty-two countries.
There are two drug master file entries for osimertinib mesylate. One supplier is listed for this compound.
Summary for OSIMERTINIB MESYLATE
| International Patents: | 140 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 60 |
| Patent Applications: | 6 |
| DailyMed Link: | OSIMERTINIB MESYLATE at DailyMed |
Pharmacology for OSIMERTINIB MESYLATE
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inducers Cytochrome P450 1A2 Inducers Breast Cancer Resistance Protein Inhibitors |
Paragraph IV (Patent) Challenges for OSIMERTINIB MESYLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TAGRISSO | TABLET;ORAL | osimertinib mesylate | 208065 | 2019-11-13 |
US Patents and Regulatory Information for OSIMERTINIB MESYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Pharms | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Astrazeneca Pharms | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Astrazeneca Pharms | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | 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 OSIMERTINIB MESYLATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Singapore | 11201605339Q | Start Trial |
| China | 104109161 | Start Trial |
| Hong Kong | 1221216 | Start Trial |
| Hungary | E049060 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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