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	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990		DISCN	Yes	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	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 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018379-002	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
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	Yes	Yes

Expired US Patents for Fresenius Medcl

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	6,875,445
Fresenius Medcl	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	4,870,105
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
	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
Japan	5335674
Poland	2484352
South Korea	20090040340
European Patent Office	2048948
Hong Kong	1202815
Russian Federation	2463060

Supplementary Protection Certificates for Fresenius Medcl Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0933372	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
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

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