GRAFAPEX Drug Patent Profile

Name: GRAFAPEX Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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When do Grafapex patents expire, and what generic alternatives are available?

Grafapex is a drug marketed by Medexus and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-six patent family members in fifteen countries.

The generic ingredient in GRAFAPEX is treosulfan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the treosulfan profile page.

DrugPatentWatch^® Generic Entry Outlook for Grafapex

Grafapex will be eligible for patent challenges on January 21, 2029. 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 January 21, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for GRAFAPEX

International Patents:	26
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3,117
What excipients (inactive ingredients) are in GRAFAPEX?	GRAFAPEX excipients list
DailyMed Link:	GRAFAPEX at DailyMed

Drug patent expirations by year for GRAFAPEX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GRAFAPEX

Generic Entry Date for GRAFAPEX^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH ACUTE MYELOID LEUKEMIA (AML) NDA: 214759 Dosage: POWDER;INTRAVENOUS

^*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.

US Patents and Regulatory Information for GRAFAPEX

GRAFAPEX is protected by one US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GRAFAPEX is ⤷ Start Trial.

This potential generic entry date is based on AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH ACUTE MYELOID LEUKEMIA (AML).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-001	Jan 21, 2025		RX	Yes	Yes	7,199,162	⤷ Start Trial				⤷ Start Trial
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-002	Jan 21, 2025		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-001	Jan 21, 2025		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-001	Jan 21, 2025		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759-002	Jan 21, 2025		RX	Yes	Yes	⤷ 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 GRAFAPEX

See the table below for patents covering GRAFAPEX around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	E251455		⤷ Start Trial
Australia	1391801	Use of treosulfan for patient conditioning before bone marrow or blood stem cell transplantation	⤷ Start Trial
Australia	777527		⤷ Start Trial
Bulgaria	106772	ПРИЛОЖЕНИЕ НА ТРЕОСУЛФАН ЗА ПОДДЪРЖАНЕ СЪСТОЯНИЕТО НА ПАЦИЕНТИ ПРЕДИ ТРАНСПЛАНТАЦИЯ НА КОСТЕН МОЗЪКИЛИ КРЪВНИ СТВОЛОВИ КЛЕТКИ (USE OF TREOSULFAN FOR PATIENT CONDITIONING BEFORE BONE MARROW OR BLOOD STEM CELL TRANSPLANTATION)	⤷ Start Trial
Bulgaria	65845		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for GRAFAPEX

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1227808	301002	Netherlands	⤷ Start Trial	PRODUCT NAME: TREOSULFAN; REGISTRATION NO/DATE: EU/1/18/1351 20190620
1227808	122019000073	Germany	⤷ Start Trial	PRODUCT NAME: TREOSULFAN; REGISTRATION NO/DATE: EU/1/18/1351 20190620
1227808	1990039-8	Sweden	⤷ Start Trial	PRODUCT NAME: TREOSULFAN; REG. NO/DATE: EU/1/18/1351 20190624
1227808	132019000000108	Italy	⤷ Start Trial	PRODUCT NAME: TREOSULFAN(TRECONDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1351, 20190624
1227808	SPC/GB19/052	United Kingdom	⤷ Start Trial	PRODUCT NAME: TREOSULFAN; REGISTERED: UK EU/1/18/1351 20190624
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Summary for GRAFAPEX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GRAFAPEX

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GRAFAPEX