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Last Updated: January 18, 2020

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VELTASSA Drug Profile

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When do Veltassa patents expire, and when can generic versions of Veltassa launch?

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

This drug has one hundred and sixty-nine patent family members in twenty-four 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

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Veltassa was eligible for patent challenges on October 21st, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 29th, 2030. This may change due to patent challenges or generic licensing.

Drug patent expirations by year for VELTASSA
Drug Prices for VELTASSA

See drug prices for VELTASSA

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 GlasgowPhase 4
NHS Greater Glasgow and ClydePhase 4
Vifor PharmaPhase 3

See all VELTASSA clinical trials

Pharmacology for VELTASSA
Synonyms for VELTASSA
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
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
>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
2957286 2018/046 Ireland   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; 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
2365988 PA2018004 Lithuania   Start Trial PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
1732523 C01732523/01 Switzerland   Start Trial PRODUCT NAME: PATIROMER; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
AstraZeneca
Moodys
Dow
Boehringer Ingelheim

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