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Last Updated: May 28, 2022

VELTASSA Drug Patent Profile


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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

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Drug patent expirations by year for VELTASSA
Drug Prices for VELTASSA

See drug prices for VELTASSA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VELTASSA
Generic Entry Date for VELTASSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of California, IrvinePhase 4
University of GlasgowPhase 4
NHS Greater Glasgow and ClydePhase 4

See all VELTASSA clinical trials

Pharmacology for VELTASSA
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VELTASSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Methods and compositions for treatment of ion imbalances
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Linear polyol stabilized polyfluoroacrylate compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERKALEMIA

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

Patent: 09282721
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0917853
Estimated Expiration: See Plans and Pricing

Canada

Patent: 35058
Estimated Expiration: See Plans and Pricing

China

Patent: 2202670
Estimated Expiration: See Plans and Pricing

Patent: 3919792
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150955
Estimated Expiration: See Plans and Pricing

Patent: 0181961
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16850
Estimated Expiration: See Plans and Pricing

Patent: 20930
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 65988
Estimated Expiration: See Plans and Pricing

Patent: 57286
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 65988
Estimated Expiration: See Plans and Pricing

Patent: 57286
Estimated Expiration: See Plans and Pricing

Patent: 31094
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2009002063
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 84675
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25934
Estimated Expiration: See Plans and Pricing

Patent: 800004
Estimated Expiration: See Plans and Pricing

Patent: 900003
Estimated Expiration: See Plans and Pricing

Japan

Patent: 56403
Estimated Expiration: See Plans and Pricing

Patent: 83471
Estimated Expiration: See Plans and Pricing

Patent: 32468
Estimated Expiration: See Plans and Pricing

Patent: 33583
Estimated Expiration: See Plans and Pricing

Patent: 90116
Estimated Expiration: See Plans and Pricing

Patent: 12500806
Estimated Expiration: See Plans and Pricing

Patent: 14144977
Estimated Expiration: See Plans and Pricing

Patent: 14144978
Estimated Expiration: See Plans and Pricing

Patent: 16145256
Estimated Expiration: See Plans and Pricing

Patent: 17218454
Estimated Expiration: See Plans and Pricing

Patent: 19065030
Estimated Expiration: See Plans and Pricing

Patent: 20172537
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 957286
Estimated Expiration: See Plans and Pricing

Patent: 2018004
Estimated Expiration: See Plans and Pricing

Patent: 2018016
Estimated Expiration: See Plans and Pricing

Patent: 57286
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0094
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 4398
Estimated Expiration: See Plans and Pricing

Patent: 11001893
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0962
Estimated Expiration: See Plans and Pricing

Norway

Patent: 18004
Estimated Expiration: See Plans and Pricing

Patent: 18041
Estimated Expiration: See Plans and Pricing

Poland

Patent: 65988
Estimated Expiration: See Plans and Pricing

Patent: 57286
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 65988
Estimated Expiration: See Plans and Pricing

Patent: 57286
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500207
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 65988
Estimated Expiration: See Plans and Pricing

Patent: 57286
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1825113
Estimated Expiration: See Plans and Pricing

Patent: 1928973
Estimated Expiration: See Plans and Pricing

Patent: 2150184
Estimated Expiration: See Plans and Pricing

Patent: 2178208
Estimated Expiration: See Plans and Pricing

Patent: 2300471
Estimated Expiration: See Plans and Pricing

Patent: 110063647
Estimated Expiration: See Plans and Pricing

Patent: 180014845
Estimated Expiration: See Plans and Pricing

Patent: 180133561
Estimated Expiration: See Plans and Pricing

Patent: 200029614
Estimated Expiration: See Plans and Pricing

Patent: 200128600
Estimated Expiration: See Plans and Pricing

Spain

Patent: 45887
Estimated Expiration: See Plans and Pricing

Patent: 99494
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 75657
Estimated Expiration: See Plans and Pricing

Patent: 95426
Estimated Expiration: See Plans and Pricing

Patent: 95427
Estimated Expiration: See Plans and Pricing

Patent: 95428
Estimated Expiration: See Plans and Pricing

Patent: 1104561
Estimated Expiration: See Plans and Pricing

Patent: 1222749
Estimated Expiration: See Plans and Pricing

Patent: 1222750
Estimated Expiration: See Plans and Pricing

Patent: 1222752
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
United Kingdom 2456256 POTASSIUM ION BINDING POLYMERS FOR PHARMACEUTICAL COMPOSITIONS See Plans and Pricing
Japan 5756403 See Plans and Pricing
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) See Plans and Pricing
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) See Plans and Pricing
Japan 5883471 See Plans and Pricing
Japan 4974882 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VELTASSA

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
McKesson
Moodys
Mallinckrodt
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.