VELTASSA Drug Patent Profile

Which patents cover Veltassa, and when can generic versions of Veltassa launch?

Veltassa is a drug marketed by Vifor Pharma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seven patent family members in twenty-seven countries.

The generic ingredient in VELTASSA is patiromer sorbitex calcium. One supplier is listed for this compound. Additional details are available on the patiromer sorbitex calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Veltassa

Veltassa was eligible for patent challenges on October 21, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 29, 2027. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VELTASSA

International Patents:	207
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	13
Drug Prices:	Drug price information for VELTASSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELTASSA
What excipients (inactive ingredients) are in VELTASSA?	VELTASSA excipients list
DailyMed Link:	VELTASSA at DailyMed

See drug prices for VELTASSA

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

Constraining patent/regulatory exclusivity:

8,282,913

NDA:

205739

Dosage:

POWDER;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 VELTASSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, Irvine	Phase 4
NHS Greater Glasgow and Clyde	Phase 4
University of Glasgow	Phase 4

See all VELTASSA clinical trials

Pharmacology for VELTASSA

Drug Class	Potassium Binder
Mechanism of Action	Potassium Ion Binding Activity

Paragraph IV (Patent) Challenges for VELTASSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VELTASSA	for Oral Suspension	patiromer sorbitex calcium	8.4 g, 16.8 g and 25.2 g	205739	2	2019-10-21

US Patents and Regulatory Information for VELTASSA

VELTASSA is protected by seven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,282,913.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No	8,216,560
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No	11,123,363
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No	8,216,560
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	Yes	9,492,476
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No	8,282,913		Y

Expired US Patents for VELTASSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015	7,556,799
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023	8,889,115
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015	8,287,847
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015	7,556,799
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023	10,485,821
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015	8,889,115
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015	8,778,324

International Patents for VELTASSA

When does loss-of-exclusivity occur for VELTASSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VELTASSA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	E453383
Austria	E460927
Australia	2005228696	Methods and compositions for treatment of ion imbalances
Australia	2005231383	Ion binding compositions
Australia	2005231424	Ion binding polymers and uses thereof
Australia	2010214729	Ion binding polymers and uses thereof
Australia	2010214732	Ion binding compositions

Supplementary Protection Certificates for VELTASSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1732523	300924	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721
2269589	CA 2018 00003	Denmark		PRODUCT NAME: PATIROMER AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179 20170721
2365988	PA2018004	Lithuania		PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2365988	CA 2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
1732523	300925	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721
1732523	122018000011	Germany		PRODUCT NAME: PATIROMER UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
1732523	2018C/004	Belgium		PRODUCT NAME: PATIROMER OF EENDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721

DrugChatter Q&A for VELTASSA

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