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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 forty patent family members in twenty-three 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.

Summary for VELTASSA

International Patents:	140
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELTASSA
DailyMed Link:	VELTASSA at DailyMed

Generic Entry Opportunity Date for VELTASSA

NDA:

205739

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.

Pharmacology for VELTASSA

Drug Class	Potassium Binder
Mechanism of Action	Potassium Ion Binding Activity

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
Relypsa Inc	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes
Relypsa Inc	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes
Relypsa Inc	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes

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Non-Orange Book US Patents for VELTASSA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,192,758	Ion binding compositions
8,282,960	Ion binding compositions
7,429,394	Ion binding compositions
8,409,561	Methods and compositions for treatment of ion imbalances

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International Patents for VELTASSA

Country	Document Number	Estimated Expiration
Portugal	2269589
European Patent Office	2184059
South Korea	101399238
China	102133196

Supplementary Protection Certificates for VELTASSA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2018004	Lithuania		PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS IR JO DRUSKOS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2018 00003	Denmark		PRODUCT NAME: PATIROMER AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179 20170721
2018 00006	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
0924	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721