PHOSLO GELCAPS Drug Patent Profile

Which patents cover Phoslo Gelcaps, and what generic alternatives are available?

Phoslo Gelcaps is a drug marketed by Fresenius Medcl and is included in one NDA.

The generic ingredient in PHOSLO GELCAPS is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phoslo Gelcaps

A generic version of PHOSLO GELCAPS was approved as calcium acetate by HIKMA on February 26^th, 2008.

Summary for PHOSLO GELCAPS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	1
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHOSLO GELCAPS
DailyMed Link:	PHOSLO GELCAPS at DailyMed

Recent Clinical Trials for PHOSLO GELCAPS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fresenius Medical Care North America	Phase 1

See all PHOSLO GELCAPS clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PHOSLO GELCAPS

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for PHOSLO GELCAPS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHOSLO GELCAPS	Capsules	calcium acetate	EQ 169 mg calcium	021160	1	2005-05-31

US Patents and Regulatory Information for PHOSLO GELCAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	AB	RX	Yes	Yes

Expired US Patents for PHOSLO GELCAPS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001

International Patents for PHOSLO GELCAPS

See the table below for patents covering PHOSLO GELCAPS around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1333884	FIXATEUR DE PHOSPHORE (PHOSPHOROUS BINDER)

Supplementary Protection Certificates for PHOSLO GELCAPS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2365988	122018000012	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	C02957286/01	Switzerland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
0521471	C300125	Netherlands		PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
2957286	2018C/047	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	6/2019	Austria		PRODUCT NAME: PATIROMER UND SEINE CALCIUM-SALZE; REGISTRATION NO/DATE: EU/1/17/1179 (MITTEILUNG) 20170721