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XOSPATA Drug Patent Profile
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Which patents cover Xospata, and what generic alternatives are available?
Xospata is a drug marketed by Astellas and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-one patent family members in twenty-nine countries.
The generic ingredient in XOSPATA is gilteritinib fumarate. One supplier is listed for this compound. Additional details are available on the gilteritinib fumarate profile page.
DrugPatentWatch® Generic Entry Outlook for Xospata
Xospata will be eligible for patent challenges on November 28, 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 July 1, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XOSPATA
| International Patents: | 61 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 6 |
| Patent Applications: | 200 |
| Drug Prices: | Drug price information for XOSPATA |
| What excipients (inactive ingredients) are in XOSPATA? | XOSPATA excipients list |
| DailyMed Link: | XOSPATA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XOSPATA
Generic Entry Date for XOSPATA*:
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 XOSPATA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
| Jazz Pharmaceuticals | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for XOSPATA
US Patents and Regulatory Information for XOSPATA
XOSPATA is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOSPATA is ⤷ Sign up for a Free Trial.
This potential generic entry date is based on patent ⤷ Sign up for a Free Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting XOSPATA
Stable pharmaceutical composition for oral administration
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Diamino heterocyclic carboxamide compound
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Diamino heterocyclic carboxamide compound
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
Patented Use: TREATMENT OF ACUTE MYELOID LEUKEMIA (AML)
FDA Regulatory Exclusivity protecting XOSPATA
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WHO HAVE RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A FMS-LIKE TYROSINE KINASE 3 (FLT3) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Sign up for a Free Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign up for a Free Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | ||||
| Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign up for a Free Trial | ⤷ Sign up for a Free Trial | Y | Y | ⤷ Sign up for a Free 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 XOSPATA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2010245545 | ⤷ Sign up for a Free Trial |
| World Intellectual Property Organization (WIPO) | 2010128659 | ⤷ Sign up for a Free Trial |
| San Marino | T201600075 | ⤷ Sign up for a Free Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XOSPATA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2428508 | LUC00147 | Luxembourg | ⤷ Sign up for a Free Trial | PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028 |
| 2428508 | PA2020002 | Lithuania | ⤷ Sign up for a Free Trial | PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
| 2428508 | PA2020002,C2428508 | Lithuania | ⤷ Sign up for a Free Trial | PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
