By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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XOFLUZA Drug Profile
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Which patents cover Xofluza, and what generic alternatives are available?
Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. There are six patents protecting this drug.
This drug has one hundred and twenty-nine patent family members in thirty-one 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.
DrugPatentWatch® 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 August 9, 2037. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XOFLUZA
| International Patents: | 129 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 4 |
| Drug Prices: | Drug price information for XOFLUZA |
| What excipients (inactive ingredients) are in XOFLUZA? | XOFLUZA excipients list |
| DailyMed Link: | XOFLUZA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XOFLUZA
Generic Entry Dates for XOFLUZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
Generic Entry Dates for XOFLUZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;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 |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| University of Washington | Phase 4 |
| Hoffmann-La Roche | N/A |
Pharmacology for XOFLUZA
| Drug Class | Polymerase Acidic Endonuclease Inhibitor |
| Mechanism of Action | Polymerase Acidic Endonuclease Inhibitors Chelating Activity |
ATC Classes for XOFLUZA
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 | 210854-003 | Mar 18, 2021 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Genentech Inc | XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410-001 | Nov 23, 2020 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854-002 | Oct 24, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Genentech Inc | XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410-001 | Nov 23, 2020 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| >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 |
|---|---|---|
| Russian Federation | 2608519 | Try Before You Buy |
| Japan | WO2012039414 | Try Before You Buy |
| Chile | 2017002711 | Try Before You Buy |
| Australia | 2011307087 | Try Before You Buy |
| Peru | 20190662 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
