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XOFLUZA Drug Profile
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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 four patents protecting this drug.
This drug has ninety-six patent family members in thirty 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.
US ANDA Litigation and Generic Entry Outlook for Xofluza
Xofluza will be eligible for patent challenges on October 24, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 27, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XOFLUZA
| International Patents: | 96 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 3 |
| 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 |
|---|---|
| University of Washington | Phase 4 |
| Hoffmann-La Roche | N/A |
| Shionogi | N/A |
Pharmacology for XOFLUZA
| Drug Class | Polymerase Acidic Endonuclease Inhibitor |
| Mechanism of Action | Polymerase Acidic Endonuclease Inhibitors Chelating Activity |
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 | Y | Y | Start Trial | ||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | 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 XOFLUZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | 2444400 | Start Trial |
| Slovenia | 2444400 | Start Trial |
| Russian Federation | 2013114189 | Start Trial |
| Japan | WO2012039414 | Start Trial |
| China | 102482219 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
