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	LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	210632-001	Apr 11, 2019		RX	Yes	Yes	9,782,376		Y
Fresenius Kabi Usa	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	040279-002	Sep 30, 1998	AP	RX	No	No
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439-001	Jun 18, 2010		RX	No	No
Fresenius Kabi Usa	NESACAINE-MPF	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	064170-002	Mar 18, 1998		DISCN	No	No
Fresenius Kabi Usa	MAGNESIUM SULFATE	magnesium sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	019316-004	Jan 29, 2016		RX	Yes	Yes
Fresenius Kabi Usa	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080618-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for Fresenius

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	5,731,356*PED
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009	6,589,960
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	4,870,086
Fresenius Medcl	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001	4,870,105
Fresenius Medcl	PHOSLO	calcium acetate	TABLET;ORAL	019976-001	Dec 10, 1990	4,870,105
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	4,695,576
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	4,695,576

Paragraph IV (Patent) Challenges for FRESENIUS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	2 mg/mL, 100 mL		2015-01-30
	Capsules	EQ 169 mg calcium		2005-05-31
	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

International Patents for Fresenius Drugs

Country	Patent Number	Estimated Expiration
Denmark	2626068
European Patent Office	2301622
Poland	1673135
Australia	2004281535
Spain	2415354
Spain	2693123
World Intellectual Property Organization (WIPO)	2004084793

Supplementary Protection Certificates for Fresenius Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0321122	SPC/GB96/057	United Kingdom		PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
0620232	C300076	Netherlands		PRODUCT NAME: CASPOFUNGINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER CASPOFUNGINE ACETAAT; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024
1532149	2011C/038	Belgium		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2--YLMETHYL)-3,7-DIHYDROPURIN-2,6-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
1224170	SPC/GB15/018	United Kingdom		PRODUCT NAME: NINTEDANIB*, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE. *NINTEDANIB IS 3-Z-(1-(4-N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-A; REGISTERED: UK EU/1/14/954/001 20141125; UK EU/1/14/954/002 20141125; UK EU/1/14/954/003 20141125; UK EU/1/14/954/004 20141125
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
0268956	SPC/GB98/040	United Kingdom		PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508

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