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-six 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
Summary for VELTASSA
| International Patents: | 196 |
| 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Ion binding polymers and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Methods and compositions for treatment of ion imbalances
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ion binding polymers and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Ion binding polymers and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ion binding polymers and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Linear polyol stabilized polyfluoroacrylate compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Ion binding polymers and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Ion binding polymers and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Ion binding polymers and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
Potassium-binding agents for treating hypertension and hyperkalemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERKALEMIA
FDA Regulatory Exclusivity protecting VELTASSA
NEW STRENGTH
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-002 | Oct 21, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-004 | Oct 2, 2023 | ⤷ Try a Trial | ⤷ Try a Trial |
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-004 | Oct 2, 2023 | ⤷ Try a Trial | ⤷ Try a Trial |
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-003 | Oct 21, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Vifor Pharma | VELTASSA | patiromer sorbitex calcium | POWDER;ORAL | 205739-004 | Oct 2, 2023 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0917853
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 35058
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2202670
Estimated Expiration: ⤷ Try a Trial
Patent: 3919792
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0150955
Estimated Expiration: ⤷ Try a Trial
Patent: 0181961
Estimated Expiration: ⤷ Try a Trial
Patent: 0230091
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16850
Estimated Expiration: ⤷ Try a Trial
Patent: 20930
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 65988
Estimated Expiration: ⤷ Try a Trial
Patent: 57286
Estimated Expiration: ⤷ Try a Trial
Patent: 31094
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 65988
Estimated Expiration: ⤷ Try a Trial
Patent: 57286
Estimated Expiration: ⤷ Try a Trial
Patent: 31094
Estimated Expiration: ⤷ Try a Trial
Patent: 01408
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 31094
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2009002063
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 84675
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 25934
Estimated Expiration: ⤷ Try a Trial
Patent: 61320
Estimated Expiration: ⤷ Try a Trial
Patent: 800004
Estimated Expiration: ⤷ Try a Trial
Patent: 900003
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 56403
Estimated Expiration: ⤷ Try a Trial
Patent: 83471
Estimated Expiration: ⤷ Try a Trial
Patent: 32468
Estimated Expiration: ⤷ Try a Trial
Patent: 33583
Estimated Expiration: ⤷ Try a Trial
Patent: 90116
Estimated Expiration: ⤷ Try a Trial
Patent: 12500806
Estimated Expiration: ⤷ Try a Trial
Patent: 14144977
Estimated Expiration: ⤷ Try a Trial
Patent: 14144978
Estimated Expiration: ⤷ Try a Trial
Patent: 16145256
Estimated Expiration: ⤷ Try a Trial
Patent: 17218454
Estimated Expiration: ⤷ Try a Trial
Patent: 19065030
Estimated Expiration: ⤷ Try a Trial
Patent: 20172537
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 957286
Estimated Expiration: ⤷ Try a Trial
Patent: 2018004
Estimated Expiration: ⤷ Try a Trial
Patent: 2018016
Estimated Expiration: ⤷ Try a Trial
Patent: 57286
Estimated Expiration: ⤷ Try a Trial
Patent: 31094
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 0094
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 4398
Estimated Expiration: ⤷ Try a Trial
Patent: 11001893
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 0962
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 18004
Estimated Expiration: ⤷ Try a Trial
Patent: 18041
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 65988
Estimated Expiration: ⤷ Try a Trial
Patent: 57286
Estimated Expiration: ⤷ Try a Trial
Patent: 31094
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 65988
Estimated Expiration: ⤷ Try a Trial
Patent: 57286
Estimated Expiration: ⤷ Try a Trial
Patent: 31094
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01500207
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 65988
Estimated Expiration: ⤷ Try a Trial
Patent: 57286
Estimated Expiration: ⤷ Try a Trial
Patent: 31094
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1825113
Estimated Expiration: ⤷ Try a Trial
Patent: 1928973
Estimated Expiration: ⤷ Try a Trial
Patent: 2150184
Estimated Expiration: ⤷ Try a Trial
Patent: 2178208
Estimated Expiration: ⤷ Try a Trial
Patent: 2300471
Estimated Expiration: ⤷ Try a Trial
Patent: 110063647
Estimated Expiration: ⤷ Try a Trial
Patent: 180014845
Estimated Expiration: ⤷ Try a Trial
Patent: 180133561
Estimated Expiration: ⤷ Try a Trial
Patent: 200029614
Estimated Expiration: ⤷ Try a Trial
Patent: 200128600
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 45887
Estimated Expiration: ⤷ Try a Trial
Patent: 99494
Estimated Expiration: ⤷ Try a Trial
Patent: 39021
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 75657
Estimated Expiration: ⤷ Try a Trial
Patent: 95426
Estimated Expiration: ⤷ Try a Trial
Patent: 95427
Estimated Expiration: ⤷ Try a Trial
Patent: 95428
Estimated Expiration: ⤷ Try a Trial
Patent: 1104561
Estimated Expiration: ⤷ Try a Trial
Patent: 1222749
Estimated Expiration: ⤷ Try a Trial
Patent: 1222750
Estimated Expiration: ⤷ Try a Trial
Patent: 1222752
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Brazil | 112015007749 | métodos para tratamento de hipertensão , de hipercaliemia , e de doença renal crônica. | ⤷ Try a Trial |
| South Korea | 20110138300 | ION BINDING COMPOSITIONS | ⤷ Try a Trial |
| China | 1980639 | Ion binding composition | ⤷ Try a Trial |
| Japan | 2014144977 | CATION-EXCHANGE CROSS-LINKED POLYMER AND COMPOSITION AND THE USE THEREOF IN TREATMENT OF HYPERKALEMIA | ⤷ Try a Trial |
| Australia | 2012254879 | Ion binding polymers and uses thereof | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VELTASSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2957286 | 2018/046 | Ireland | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719 |
| 2957286 | LUC00094 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721 |
| 2957286 | C20190015 00286 | Estonia | ⤷ Try a Trial | PRODUCT NAME: KALTSIUMPATIROMEER;REG NO/DATE: EU/1/17/1179 21.07.2017 |
| 2957286 | 6/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721 |
| 2957286 | 132019000000021 | Italy | ⤷ Try a Trial | PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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