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Fresenius Medcl Company Profile

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What is the competitive landscape for FRESENIUS MEDCL, and what generic alternatives to FRESENIUS MEDCL drugs are available?

FRESENIUS MEDCL has nine approved drugs.

There are five US patents protecting FRESENIUS MEDCL drugs.

There are twenty-two patent family members on FRESENIUS MEDCL drugs in seventeen countries and sixty-five supplementary protection certificates in twelve countries.

Summary for Fresenius Medcl

International Patents:	22
US Patents:	5
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	INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride; dextrose; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	019395-003	Mar 26, 1986		DISCN	No	No
Fresenius Medcl	DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018379-006	Jul 7, 1982		DISCN	No	No
Fresenius Medcl	INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	019395-001	Mar 26, 1986		DISCN	No	No
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	No	No
Fresenius Medcl	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018883-006	Nov 30, 1984	AT	RX	No	No
Fresenius Medcl	DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018883-005	Nov 30, 1984	AT	RX	No	No
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	AB	RX	Yes	Yes	6,576,665

Expired US Patents for Fresenius Medcl

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	4,870,105
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001	4,870,105
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	4,870,105
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	4,870,105

Paragraph IV (Patent) Challenges for FRESENIUS MEDCL drugs

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

International Patents for Fresenius Medcl Drugs

Country	Patent Number	Estimated Expiration
Poland	2484352
Mexico	2009000722
New Zealand	574331
Israel	196584
European Patent Office	2484352
Hong Kong	1202815
Japan	2009544615

Supplementary Protection Certificates for Fresenius Medcl Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
2365988	2018C/006	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM OF EERDER WELK ZOUT OF AFGELEIDE ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
1732523	300925	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM EN ALLE ZOUTEN DAARVAN
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625

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