Fresenius Company Profile

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

FRESENIUS has three hundred and twenty-three approved drugs.

There are twenty-six US patents protecting FRESENIUS drugs. There are two tentative approvals on FRESENIUS drugs.

There are one hundred and fifty patent family members on FRESENIUS drugs in twenty-seven countries and four hundred and sixty-two supplementary protection certificates in seventeen countries.

Summary for Fresenius

International Patents:	150
US Patents:	26
Tradenames:	276
Ingredients:	190
NDAs:	323
Patent Litigation for Fresenius:	See patent lawsuits for Fresenius
PTAB Cases with Fresenius as petitioner:	See PTAB cases with Fresenius as petitioner
PTAB Cases with Fresenius as patent owner:	See PTAB cases with Fresenius as patent owner

Drugs and US Patents for Fresenius

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488-018	Nov 13, 1986		RX	Yes	Yes
Fresenius Medcl	DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	SOLUTION;INTRAPERITONEAL	018883-003	Nov 30, 1984	AT	RX	Yes	Yes
Fresenius	INTRALIPID 20%	soybean oil	INJECTABLE;INJECTION	020248-001	Aug 7, 1996	AP	RX	Yes	Yes
Fresenius Kabi Usa	TRANEXAMIC ACID	tranexamic acid	INJECTABLE;INJECTION	091596-001	Mar 2, 2012	AP	RX	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 Kabi Usa	MORPHINE SULFATE	morphine sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	204223-003	Oct 30, 2013		RX	Yes	Yes	9,248,229		Y

Expired US Patents for Fresenius

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	4,870,105
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	4,695,576
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998	5,834,489
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994	6,589,960
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984	6,589,960
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	6,589,960

Paragraph IV (Patent) Challenges for FRESENIUS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Oral Solution	5 mg/5mL		2011-02-25
	Tablets	2 mg, 4 mg, and 8 mg		2013-08-05
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Injection	2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials		2006-11-13
	Injection	2 mg/mL, 200 mL		2015-09-03
	Oral Solution	667 mg/5 mL		2013-12-05
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Injection	2 mg/mL		2011-06-22
	Injection	10 mg/mL		2011-11-04
	for Injection	200 mcg/vial		2015-05-01
	Injection	2 mg/mL, 100 mL		2015-01-30
	Capsules	EQ 169 mg calcium		2005-05-31

International Patents for Fresenius Drugs

Country	Patent Number	Estimated Expiration
Australia	2011201893
Brazil	PI0415438
Hungary	E026823
China	104095838
Cyprus	1120016
Brazil	PI0408780

Supplementary Protection Certificates for Fresenius Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
1020461	C300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
2785706	LUC00158	Luxembourg		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2701720	23C1000	France		PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221

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