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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Questions you can ask:
- What is the 5 year forecast for VELTASSA?
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Summary for VELTASSA
International Patents: | 198 |
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 |
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
Sponsor | Phase |
---|---|
University of California, Irvine | Phase 4 |
NHS Greater Glasgow and Clyde | Phase 4 |
University of Glasgow | Phase 4 |
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 and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VELTASSA is ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 205739-002 | Oct 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-002 | Oct 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-004 | Oct 2, 2023 | ⤷ Subscribe | ⤷ Subscribe |
Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-002 | Oct 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-002 | Oct 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-002 | Oct 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
>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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 2202670
Patent: Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia
Estimated Expiration: ⤷ Subscribe
Patent: 3919792
Patent: Crosslinked Cation Exchange Polymers, Compositions And Use In Treating Hyperkalemia
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0150955
Estimated Expiration: ⤷ Subscribe
Patent: 0181961
Estimated Expiration: ⤷ Subscribe
Patent: 0230091
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 16850
Estimated Expiration: ⤷ Subscribe
Patent: 20930
Estimated Expiration: ⤷ Subscribe
Patent: 18002
Estimated Expiration: ⤷ Subscribe
Patent: 19002
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 65988
Estimated Expiration: ⤷ Subscribe
Patent: 57286
Estimated Expiration: ⤷ Subscribe
Patent: 31094
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Finland
Patent: 31094
Estimated Expiration: ⤷ Subscribe
Germany
Patent: 2009002063
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 84675
Patent: CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 25934
Estimated Expiration: ⤷ Subscribe
Patent: 61320
Estimated Expiration: ⤷ Subscribe
Patent: 800004
Estimated Expiration: ⤷ Subscribe
Patent: 900003
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 56403
Estimated Expiration: ⤷ Subscribe
Patent: 83471
Estimated Expiration: ⤷ Subscribe
Patent: 32468
Estimated Expiration: ⤷ Subscribe
Patent: 33583
Estimated Expiration: ⤷ Subscribe
Patent: 90116
Estimated Expiration: ⤷ Subscribe
Patent: 12500806
Estimated Expiration: ⤷ Subscribe
Patent: 14144977
Patent: CATION-EXCHANGE CROSS-LINKED POLYMER AND COMPOSITION AND THE USE THEREOF IN TREATMENT OF HYPERKALEMIA
Estimated Expiration: ⤷ Subscribe
Patent: 14144978
Patent: CATION-EXCHANGE CROSS-LINKED POLYMER AND COMPOSITION AND THE USE THEREOF IN TREATMENT OF HYPERKALEMIA
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Lithuania
Patent: 957286
Estimated Expiration: ⤷ Subscribe
Patent: 2018004
Estimated Expiration: ⤷ Subscribe
Patent: 2018016
Estimated Expiration: ⤷ Subscribe
Patent: 57286
Estimated Expiration: ⤷ Subscribe
Patent: 31094
Estimated Expiration: ⤷ Subscribe
Luxembourg
Patent: 0094
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Netherlands
Patent: 0962
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 18004
Estimated Expiration: ⤷ Subscribe
Patent: 18041
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 65988
Estimated Expiration: ⤷ Subscribe
Patent: 57286
Estimated Expiration: ⤷ Subscribe
Patent: 31094
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 65988
Estimated Expiration: ⤷ Subscribe
Patent: 57286
Estimated Expiration: ⤷ Subscribe
Patent: 31094
Estimated Expiration: ⤷ Subscribe
San Marino
Patent: 01500207
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 65988
Estimated Expiration: ⤷ Subscribe
Patent: 57286
Estimated Expiration: ⤷ Subscribe
Patent: 31094
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1825113
Estimated Expiration: ⤷ Subscribe
Patent: 1928973
Estimated Expiration: ⤷ Subscribe
Patent: 2150184
Estimated Expiration: ⤷ Subscribe
Patent: 2178208
Estimated Expiration: ⤷ Subscribe
Patent: 2300471
Estimated Expiration: ⤷ Subscribe
Patent: 110063647
Patent: CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA
Estimated Expiration: ⤷ Subscribe
Patent: 180014845
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷ Subscribe
Patent: 180133561
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷ Subscribe
Patent: 200029614
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷ Subscribe
Patent: 200128600
Patent: 가교결합된 양이온교환 폴리머, 조성물 및 고칼륨혈증 치료 용도 (CROSSLINKED CATION EXCHANGE POLYMERS COMPOSITIONS AND USE IN TREATING HYPERKALEMIA)
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 45887
Estimated Expiration: ⤷ Subscribe
Patent: 99494
Estimated Expiration: ⤷ Subscribe
Patent: 39021
Estimated Expiration: ⤷ Subscribe
United Kingdom
Patent: 75657
Patent: Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia
Estimated Expiration: ⤷ Subscribe
Patent: 95426
Patent: Use of a crosslinked cation exchange polymer in removing potassium from the gastrointestinal tract of an animal
Estimated Expiration: ⤷ Subscribe
Patent: 95427
Patent: Use of a crosslinked cation exchange polymer in removing potassium from the gastrointestinal tract of an animal
Estimated Expiration: ⤷ Subscribe
Patent: 95428
Patent: Use of a crosslinked cation exchange polymer in removing potassium from the gastrointestinal tract of an animal
Estimated Expiration: ⤷ Subscribe
Patent: 1104561
Estimated Expiration: ⤷ Subscribe
Patent: 1222749
Estimated Expiration: ⤷ Subscribe
Patent: 1222750
Estimated Expiration: ⤷ Subscribe
Patent: 1222752
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Finland | 3431094 | ⤷ Subscribe | |
Spain | 2720612 | ⤷ Subscribe | |
Portugal | 2269589 | ⤷ Subscribe | |
San Marino | T201500207 | ⤷ Subscribe | |
Japan | 2007531774 | ⤷ Subscribe | |
Australia | 2012254879 | Ion binding polymers and uses thereof | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VELTASSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1732523 | 122018000011 | Germany | ⤷ Subscribe | PRODUCT NAME: PATIROMER UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
2957286 | LUC00094 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
2957286 | 2018/046 | Ireland | ⤷ Subscribe | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
2957286 | PA2018016 | Lithuania | ⤷ Subscribe | PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
2957286 | SPC/GB19/003 | United Kingdom | ⤷ Subscribe | 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 | C 2019 004 | Romania | ⤷ Subscribe | PRODUCT NAME: PATIROMER SORBITEX SARE DE CALCIU; NATIONAL AUTHORISATION NUMBER: EU/1/17/1179/001-009; DATE OF NATIONAL AUTHORISATION: 20170719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1179/001-009; DATE OF FIRST AUTHORISATION IN EEA: 20170719 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
VELTASSA Market Analysis and Financial Projection Experimental
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