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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VELTASSA?
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- What is Average Wholesale Price for VELTASSA?
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
*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 ⤷ 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 | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-002 | 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | DISCN | Yes | No | ⤷ 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 | 205739-002 | Oct 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-001 | 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 | 205739-003 | Oct 21, 2015 | ⤷ 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 |
|---|---|---|---|
| Spain | 2453048 | ⤷ Sign Up | |
| United Kingdom | 0621242 | ⤷ Sign Up | |
| Portugal | 3431094 | ⤷ Sign Up | |
| Japan | 2007531758 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VELTASSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2957286 | 300962 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721 |
| 2957286 | CR 2018 00043 | Denmark | ⤷ Sign Up | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179/001-009 20170721 |
| 2957286 | 6/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721 |
| 2957286 | 18C1053 | France | ⤷ Sign Up | PRODUCT NAME: PATIROMER; NAT. REGISTRATION NO/DATE: EU/1/17/1179 20170721; FIRST REGISTRATION: - 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.
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