Fresenius Medcl Company Profile

What is the competitive landscape for FRESENIUS MEDCL, and when can generic versions of FRESENIUS MEDCL drugs launch?

FRESENIUS MEDCL has nine approved drugs.

There are three US patents protecting FRESENIUS MEDCL drugs.

There are twenty-one patent family members on FRESENIUS MEDCL drugs in sixteen countries and ninety-three supplementary protection certificates in thirteen countries.

Summary for Fresenius Medcl

International Patents:	21
US Patents:	3
Tradenames:	22
Ingredients:	5
NDAs:	9

Drugs and US Patents for Fresenius Medcl

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Medcl	DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018883-002	Nov 30, 1984	AT	RX	Yes	Yes
Fresenius Medcl	DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018379-007	Jun 24, 1988		DISCN	No	No
Fresenius Medcl	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	078177-001	Apr 12, 2007	AP	RX	No	No
Fresenius Medcl	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075766-001	Feb 20, 2003		DISCN	No	No
Fresenius Medcl	DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018379-004	Jul 7, 1982		DISCN	No	No
Fresenius Medcl	DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018379-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Medcl	DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018379-008	Jun 24, 1988		DISCN	No	No

Expired US Patents for Fresenius Medcl

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	6,576,665
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	6,576,665
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001	4,870,105
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	4,870,105
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	6,875,445
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	4,870,105
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	4,870,105

Paragraph IV (Patent) Challenges for FRESENIUS MEDCL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	EQ 169 mg calcium		2005-05-31
	Oral Solution	667 mg/5 mL		2013-12-05

International Patents for Fresenius Medcl Drugs

Country	Patent Number	Estimated Expiration
Canada	2658465
Japan	5335674
Spain	2382993
South Korea	20090040340
European Patent Office	2048948
Russian Federation	2463060
World Intellectual Property Organization (WIPO)	2008011126

Supplementary Protection Certificates for Fresenius Medcl Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2365988	LUC00061	Luxembourg		PRODUCT NAME: PATIROMER SORBITEX CALCIUM ET TOUS LES SELS ET DERIVES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
2673237	1990016-6	Sweden		PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Fresenius
• Fresenius Kabi
• Fresenius Kabi Oncol
• Fresenius Kabi Usa
• Fresenius Medcl