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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-five patent family members in twenty-six 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, 2030. 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:	185
US Patents:	13
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 Generic Entry Opportunity Date for VELTASSA

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
University of Glasgow	Phase 4
NHS Greater Glasgow and Clyde	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 thirteen US patents.

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 VELTASSA

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		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	No				Y

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

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Hungary

Japan

Lithuania

Luxembourg

Mexico

Netherlands

Norway

Poland

Portugal

San Marino

Slovenia

South Korea

Spain

United Kingdom

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
Spain	2453048
United Kingdom	2456256	POTASSIUM ION BINDING POLYMERS FOR PHARMACEUTICAL COMPOSITIONS
Japan	5756403
Japan	2020172537	架橋陽イオン交換ポリマー、組成物、および高カリウム血症の治療における使用 (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Japan	2019065030	架橋陽イオン交換ポリマー、組成物、および高カリウム血症の治療における使用 (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Japan	5883471
Japan	4974882

Supplementary Protection Certificates for VELTASSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	CA 2018 00043	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2957286	2018C/047	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
1732523	122018000011	Germany		PRODUCT NAME: PATIROMER UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	PA2018016,C2957286	Lithuania		PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	404 50019-2018	Slovakia		PRODUCT NAME: PATIROMER SORBITEX KALCIUM; REGISTRATION NO/DATE: EU/1/17/1179/001 - EU/1/17/1179/009 20170721
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721