Fresenius Kabi Company Profile

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What is the competitive landscape for FRESENIUS KABI

FRESENIUS KABI has three hundred and thirty-four approved drugs.

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

Summary for Fresenius Kabi

US Patents:	24
Tradenames:	270
Ingredients:	203
NDAs:	334
Patent Litigation for Fresenius Kabi:	See patent lawsuits for Fresenius Kabi
PTAB Cases with Fresenius Kabi as petitioner:	See PTAB cases with Fresenius Kabi as petitioner
PTAB Cases with Fresenius Kabi as patent owner:	See PTAB cases with Fresenius Kabi as patent owner

Drugs and US Patents for Fresenius Kabi

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	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	213573-002	Apr 2, 2024	AP	RX	No	No
Fresenius Kabi Usa	CARBOPLATIN	carboplatin	INJECTABLE;INJECTION	076235-002	Oct 14, 2004		DISCN	No	No
Fresenius Kabi Usa	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040612-001	Aug 12, 2004	AP	RX	No	No
Fresenius Kabi Usa	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077247-001	Oct 21, 2004		DISCN	No	No
Fresenius Kabi Usa	XYLOCAINE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	016801-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Fresenius Kabi Usa	DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	078718-002	Sep 15, 2009	AP	RX	No	No
Fresenius Kabi Usa	NEBUPENT	pentamidine isethionate	FOR SOLUTION;INHALATION	019887-001	Jun 15, 1989	AN	RX	Yes	Yes

Expired US Patents for Fresenius Kabi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998	5,670,524
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	7,828,787
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	4,870,086
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-002	Jul 27, 2018	10,350,186
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998	4,695,576
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	8,162,915
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	5,834,489

Paragraph IV (Patent) Challenges for FRESENIUS KABI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Oral Solution	5 mg/5mL		2011-02-25

International Patents for Fresenius Kabi Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014140095
China	100577234
Slovenia	1673135
Australia	2014230836
Cyprus	1120016
World Intellectual Property Organization (WIPO)	2012047845
China	107820421

Supplementary Protection Certificates for Fresenius Kabi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0383579	SZ 34/1996	Austria		PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
1948158	122016000038	Germany		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2768484	19C1063	France		PRODUCT NAME: COMBINAISON DE DAUNORUBICINE ET CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1425001	SPC/GB14/034	United Kingdom		PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
3752510	PA2025542	Lithuania		PRODUCT NAME: VANZACAFTOR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY ACALCIUM SALT THEREOF; REGISTRATION NO/DATE: EU/1/25/1943 20250630
0296749	09C0055	France		PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811

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
• Fresenius Medcl Care