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-five 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-three supplementary protection certificates in seventeen countries.

Summary for Fresenius

International Patents:	150
US Patents:	26
Tradenames:	281
Ingredients:	192
NDAs:	325
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	NAFCILLIN SODIUM	nafcillin sodium	INJECTABLE;INJECTION	206761-001	Jun 2, 2020	AP	RX	No	No
Fresenius Kabi Usa	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	INJECTABLE;INTRAVENOUS	208619-003	Jan 31, 2023		DISCN	No	No
Fresenius Kabi Usa	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040583-002	Jul 30, 2004	AP	RX	No	No
Fresenius Kabi Usa	POLOCAINE-MPF	mepivacaine hydrochloride	INJECTABLE;INJECTION	089409-001	Dec 1, 1986	AP	RX	No	No
Fresenius Kabi Usa	TIGECYCLINE	tigecycline	POWDER;INTRAVENOUS	205645-001	Dec 1, 2016	AP	RX	Yes	Yes
Fresenius Kabi Usa	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	090799-002	Jul 25, 2011	AP	RX	No	No

Expired US Patents for Fresenius

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994	6,589,960
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	8,118,802
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-006	Sep 24, 1996	8,118,802
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	5,908,869*PED
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	5,670,524
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
	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
	Injection	2 mg/mL, 100 mL		2015-01-30

International Patents for Fresenius Drugs

Country	Patent Number	Estimated Expiration
Hong Kong	1208015
Hong Kong	1166957
Spain	2343456
Australia	2014230834
Slovenia	1605891
Poland	373496

Supplementary Protection Certificates for Fresenius Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1273292	C01273292/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
2701720	3/2023	Austria		PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1183240	C 2010 011	Romania		PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...]
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204

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