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Last Updated: July 16, 2024

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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 ninety-eight 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, 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

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Drug ClassPotassium Binder
Mechanism of ActionPotassium 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 and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VELTASSA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Methods and compositions for treatment of ion imbalances
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Ion binding polymers and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Ion binding polymers and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Linear polyol stabilized polyfluoroacrylate compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Ion binding polymers and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HYPERKALEMIA

FDA Regulatory Exclusivity protecting VELTASSA

NEW STRENGTH
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

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 205739-002 Oct 21, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-002 Oct 21, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 205739-004 Oct 2, 2023 ⤷  Sign Up ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-002 Oct 21, 2015 ⤷  Sign Up ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 ⤷  Sign Up ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-004 Oct 2, 2023 ⤷  Sign Up ⤷  Sign Up
Vifor Pharma VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-004 Oct 2, 2023 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
Patent: Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0917853
Patent: composição farmacêutica, polímero reticulado de troca catiônica ou uma composição farmacêutica para remover potássio do trato gastrointestinal, polímetro carboxílico alifático reticulado estabilizado de poliol linear, e, método para fazer um polímetro reticulado de troca catiônica
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 35058
Patent: POLYMERES RETICULES ECHANGEURS CATIONIQUES, COMPOSITIONS ET UTILISATION DANS LE TRAITEMENT DE L'HYPERKALIEMIE (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2202670
Patent: Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia
Estimated Expiration: ⤷  Sign Up

Patent: 3919792
Patent: Crosslinked Cation Exchange Polymers, Compositions And Use In Treating Hyperkalemia
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150955
Estimated Expiration: ⤷  Sign Up

Patent: 0181961
Estimated Expiration: ⤷  Sign Up

Patent: 0230091
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16850
Estimated Expiration: ⤷  Sign Up

Patent: 20930
Estimated Expiration: ⤷  Sign Up

Patent: 18002
Estimated Expiration: ⤷  Sign Up

Patent: 19002
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 65988
Estimated Expiration: ⤷  Sign Up

Patent: 57286
Estimated Expiration: ⤷  Sign Up

Patent: 31094
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 65988
Patent: POLYMÈRES RÉTICULÉS ÉCHANGEURS CATIONIQUES, COMPOSITIONS ET UTILISATION DANS LE TRAITEMENT DE L'HYPERKALIÉMIE (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Patent: 57286
Patent: COMPOSITIONS COMPRENANT DES POLYMERES RETICULES ECHANGEURS CATIONIQUES ET UTILISATION DANS LE TRAITEMENT DE L'HYPERKALIEMIE (COMPOSITIONS COMPRISING CROSSLINKED CATION EXCHANGE POLYMERS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Patent: 31094
Patent: POLYMÈRES D'ÉCHANGE DE CATIONS RÉTICULÉS, COMPOSITIONS ET UTILISATION DANS LE TRAITEMENT DE L'HYPERKALIÉMIE (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Patent: 01408
Patent: POLYMÈRES RÉTICULÉS ÉCHANGEURS DE CATIONS, COMPOSITIONS ET UTILISATION DANS LE TRAITEMENT DE L'HYPERKALIÉMIE (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 31094
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2009002063
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 84675
Patent: CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 25934
Estimated Expiration: ⤷  Sign Up

Patent: 61320
Estimated Expiration: ⤷  Sign Up

Patent: 800004
Estimated Expiration: ⤷  Sign Up

Patent: 900003
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 56403
Estimated Expiration: ⤷  Sign Up

Patent: 83471
Estimated Expiration: ⤷  Sign Up

Patent: 32468
Estimated Expiration: ⤷  Sign Up

Patent: 33583
Estimated Expiration: ⤷  Sign Up

Patent: 90116
Estimated Expiration: ⤷  Sign Up

Patent: 12500806
Estimated Expiration: ⤷  Sign Up

Patent: 14144977
Patent: CATION-EXCHANGE CROSS-LINKED POLYMER AND COMPOSITION AND THE USE THEREOF IN TREATMENT OF HYPERKALEMIA
Estimated Expiration: ⤷  Sign Up

Patent: 14144978
Patent: CATION-EXCHANGE CROSS-LINKED POLYMER AND COMPOSITION AND THE USE THEREOF IN TREATMENT OF HYPERKALEMIA
Estimated Expiration: ⤷  Sign Up

Patent: 16145256
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 17218454
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 19065030
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 20172537
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 957286
Estimated Expiration: ⤷  Sign Up

Patent: 2018004
Estimated Expiration: ⤷  Sign Up

Patent: 2018016
Estimated Expiration: ⤷  Sign Up

Patent: 57286
Estimated Expiration: ⤷  Sign Up

Patent: 31094
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0094
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 4398
Patent: POLIMEROS RETICULADOS DE INTERCAMBIO CATIONICO, COMPOSICIONES Y USO EN EL TRATAMIENTO DE LA HIPERCALCEMIA. (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA.)
Estimated Expiration: ⤷  Sign Up

Patent: 11001893
Patent: POLIMEROS RETICULADOS DE INTERCAMBIO CATIONICO, COMPOSICIONES Y USO EN EL TRATAMIENTO DE HIPERCALEMIA. (CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA.)
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0962
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 18004
Estimated Expiration: ⤷  Sign Up

Patent: 18041
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 65988
Estimated Expiration: ⤷  Sign Up

Patent: 57286
Estimated Expiration: ⤷  Sign Up

Patent: 31094
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 65988
Estimated Expiration: ⤷  Sign Up

Patent: 57286
Estimated Expiration: ⤷  Sign Up

Patent: 31094
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01500207
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 65988
Estimated Expiration: ⤷  Sign Up

Patent: 57286
Estimated Expiration: ⤷  Sign Up

Patent: 31094
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1825113
Estimated Expiration: ⤷  Sign Up

Patent: 1928973
Estimated Expiration: ⤷  Sign Up

Patent: 2150184
Estimated Expiration: ⤷  Sign Up

Patent: 2178208
Estimated Expiration: ⤷  Sign Up

Patent: 2300471
Estimated Expiration: ⤷  Sign Up

Patent: 110063647
Patent: CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA
Estimated Expiration: ⤷  Sign Up

Patent: 180014845
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Patent: 180133561
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Patent: 200029614
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Patent: 200128600
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 45887
Estimated Expiration: ⤷  Sign Up

Patent: 99494
Estimated Expiration: ⤷  Sign Up

Patent: 39021
Estimated Expiration: ⤷  Sign Up

United Kingdom

Patent: 75657
Patent: Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia
Estimated Expiration: ⤷  Sign Up

Patent: 95426
Patent: Use of a crosslinked cation exchange polymer in removing potassium from the gastrointestinal tract of an animal
Estimated Expiration: ⤷  Sign Up

Patent: 95427
Patent: Use of a crosslinked cation exchange polymer in removing potassium from the gastrointestinal tract of an animal
Estimated Expiration: ⤷  Sign Up

Patent: 95428
Patent: Use of a crosslinked cation exchange polymer in removing potassium from the gastrointestinal tract of an animal
Estimated Expiration: ⤷  Sign Up

Patent: 1104561
Estimated Expiration: ⤷  Sign Up

Patent: 1222749
Estimated Expiration: ⤷  Sign Up

Patent: 1222750
Estimated Expiration: ⤷  Sign Up

Patent: 1222752
Estimated Expiration: ⤷  Sign Up

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
South Korea 101228233 ⤷  Sign Up
Germany 112005000730 Ionen bindende Polymere und ihre Verwendung ⤷  Sign Up
Spain 2939021 ⤷  Sign Up
Austria E460927 ⤷  Sign Up
United Kingdom 2475657 Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VELTASSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2269589 CA 2018 00003 Denmark ⤷  Sign Up PRODUCT NAME: PATIROMER AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179 20170721
2957286 SPC/GB19/003 United Kingdom ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTERED: UK EU/1/17/1179/001(NI) 20170721; UK EU/1/17/1179/002(NI) 20170721; UK EU/1/17/1179/003(NI) 20170721; UK EU/1/17/1179/004(NI) 20170721; UK EU/1/17/1179/005(NI) 20170721; UK EU/1/17/1179/006(NI) 20170721; UK EU/1/17/1179/007(NI) 20170721; UK EU/1/17/1179/008(NI) 20170721; UK EU/1/17/1179/009(NI) 20170721; UK PLGB 50784/0002-0001 20170721; UK PLGB 50784/0003-0001 20170721; UK PLGB 50784/0004-0001 20170721
2957286 300962 Netherlands ⤷  Sign Up PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
1732523 C01732523/01 Switzerland ⤷  Sign Up PRODUCT NAME: PATIROMER; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
1732523 2018C/004 Belgium ⤷  Sign Up PRODUCT NAME: PATIROMER OF EENDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.