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Last Updated: February 28, 2021

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VELTASSA Drug Profile

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Which patents cover Veltassa, and when can generic versions of Veltassa launch?

Veltassa is a drug marketed by Relypsa Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and seventy-nine 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.

US ANDA Litigation and 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.

Indicators of Generic Entry

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Drug patent expirations by year for VELTASSA
Drug Prices for VELTASSA

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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
NHS Greater Glasgow and ClydePhase 4
University of GlasgowPhase 4

See all VELTASSA clinical trials

Pharmacology for VELTASSA
Paragraph IV (Patent) Challenges for VELTASSA
Tradename Dosage Ingredient NDA Submissiondate
VELTASSA POWDER;ORAL patiromer sorbitex calcium 205739 2019-10-21

US Patents and Regulatory Information for VELTASSA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Relypsa Inc VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Relypsa Inc VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Relypsa Inc VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Relypsa Inc VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-003 Oct 21, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Relypsa Inc VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-001 Oct 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Relypsa Inc VELTASSA patiromer sorbitex calcium POWDER;ORAL 205739-002 Oct 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VELTASSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2957286 LUC00094 Luxembourg   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
1732523 122018000011 Germany   Start Trial PRODUCT NAME: PATIROMER UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 2018C/047 Belgium   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 6/2019 Austria   Start Trial PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721
2269589 CA 2018 00003 Denmark   Start Trial PRODUCT NAME: PATIROMER AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179 20170721
2365988 2018C/006 Belgium   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER 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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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.