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Last Updated: April 5, 2020

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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-one patent family members in twenty-five 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
NHS Greater Glasgow and ClydePhase 4
University of GlasgowPhase 4
Vifor PharmaPhase 3

See all VELTASSA clinical trials

Pharmacology for VELTASSA
Synonyms for VELTASSA
0LB9J2797D
1415477-49-4
Calcium, hydrolyzed divinylbenzene-Me 2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes
Cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol
Patiromer sorbitex calcium
Patiromer sorbitex calcium [USAN]
RLY5016S
UNII-0LB9J2797D
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 Y   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 Y   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 2018/046 Ireland   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
1732523 132018000000061 Italy   Start Trial PRODUCT NAME: PATIROMER E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721
2957286 1990003-4 Sweden   Start Trial PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
1732523 2018C/004 Belgium   Start Trial PRODUCT NAME: PATIROMER OF EENDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286 PA2018016,C2957286 Lithuania   Start Trial PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 PA2018016 Lithuania   Start Trial PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.