PATIROMER SORBITEX CALCIUM - Generic Drug Details

What are the generic drug sources for patiromer sorbitex calcium and what is the scope of patent protection?

Patiromer sorbitex calcium is the generic ingredient in one branded drug marketed by Vifor Pharma and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Patiromer sorbitex calcium has one hundred and ninety-eight patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for PATIROMER SORBITEX CALCIUM

International Patents:	198
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PATIROMER SORBITEX CALCIUM
DailyMed Link:	PATIROMER SORBITEX CALCIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PATIROMER SORBITEX CALCIUM

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 PATIROMER SORBITEX CALCIUM

Drug Class	Potassium Binder
Mechanism of Action	Potassium Ion Binding Activity

Paragraph IV (Patent) Challenges for PATIROMER SORBITEX CALCIUM

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 PATIROMER SORBITEX CALCIUM

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	205739-003	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	No			Y
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		RX	Yes	Yes
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	No			Y
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		DISCN	Yes	No

Expired US Patents for PATIROMER SORBITEX CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015

International Patents for PATIROMER SORBITEX CALCIUM

Country	Patent Number	Title	Estimated Expiration
Japan	5883471
European Patent Office	2957286	COMPOSITIONS COMPRENANT DES POLYMERES RETICULES ECHANGEURS CATIONIQUES ET UTILISATION DANS LE TRAITEMENT DE L'HYPERKALIEMIE (COMPOSITIONS COMPRISING CROSSLINKED CATION EXCHANGE POLYMERS AND USE IN TREATING HYPERKALEMIA)
European Patent Office	1732524	PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DE DESEQUILIBRES IONIQUES (METHODS AND COMPOSITIONS FOR TREATMENT OF ION IMBALANCES)
Hungary	E061320
Australia	2009282721	Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia
United Kingdom	2430368	Methods and compositions for treatment of ion imbalances
South Korea	20110063647	CROSSLINKED CATION EXCHANGE POLYMERS, COMPOSITIONS AND USE IN TREATING HYPERKALEMIA

Supplementary Protection Certificates for PATIROMER SORBITEX CALCIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	6/2019	Austria		PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721
1732523	300924	Netherlands		PRODUCT NAME: PATIROMER EN ALLE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/17/1179/001-009 20170721
2957286	CA 2018 00043	Denmark		PRODUCT NAME: PATIROMER SORBITEX CALCIUM AND ANY SALTS AND DERIVATIVES THEREOF; REG. NO/DATE: EU/1/17/1179/001-009 20170721
2957286	C201930008	Spain		PRODUCT NAME: PATIROMERO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1179; DATE OF AUTHORISATION: 20170719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1179; DATE OF FIRST AUTHORISATION IN EEA: 20170719
2957286	PA2018016	Lithuania		PRODUCT NAME: PATIROMERO, SORBITOLIO IR KALCIO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	132019000000021	Italy		PRODUCT NAME: PATIROMER SORBITEX CALCIUM E QUALSIASI SUO SALE O DERIVATO(VELTASSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1179, 20170721