DrugPatentWatch Database Preview
XOFLUZA Drug Profile
When do Xofluza patents expire, and when can generic versions of Xofluza launch?
Xofluza is a drug marketed by Genentech Inc and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-four patent family members in twenty-two countries.
The generic ingredient in XOFLUZA is baloxavir marboxil. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.
Summary for XOFLUZA
| International Patents: | 64 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for XOFLUZA |
| DailyMed Link: | XOFLUZA at DailyMed |
Generic Entry Opportunity Date for XOFLUZA
Generic Entry Date for XOFLUZA*:
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 XOFLUZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shionogi | N/A |
| Hoffmann-La Roche | N/A |
| Hoffmann-La Roche | Phase 3 |
US Patents and Regulatory Information for XOFLUZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-001 | Oct 24, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-001 | Oct 24, 2018 | RX | Yes | No | Start Trial | Start Trial | 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 XOFLUZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2620436 | Start Trial |
| Serbia | 57244 | Start Trial |
| Serbia | 57490 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
