Fresenius Kabi Company Profile

What is the competitive landscape for FRESENIUS KABI, and when can generic versions of FRESENIUS KABI drugs launch?

FRESENIUS KABI has three hundred and nine approved drugs.

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

There are one hundred and twenty-nine patent family members on FRESENIUS KABI drugs in twenty-five countries and four hundred and sixty-three supplementary protection certificates in seventeen countries.

Summary for Fresenius Kabi

International Patents:	129
US Patents:	23
Tradenames:	253
Ingredients:	187
NDAs:	309
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	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	209476-001	Mar 13, 2019	AP	RX	No	No
Fresenius Kabi Usa	XYLOCAINE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	016801-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	dextrose; sodium chloride	INJECTABLE;INJECTION	211211-001	Sep 14, 2020	AP	RX	No	No
Fresenius Kabi Usa	CIPROFLOXACIN	ciprofloxacin	INJECTABLE;INJECTION	076484-001	Aug 28, 2006		DISCN	No	No
Fresenius Kabi Usa	LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	207226-001	Jul 27, 2018		RX	No	Yes
Fresenius Kabi Usa	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077266-004	Feb 15, 2006	AP	RX	No	No
Fresenius Kabi Usa	SMOFLIPID 20%	fish oil; medium chain triglycerides; olive oil; soybean oil	EMULSION;INTRAVENOUS	207648-002	Jul 13, 2016		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	5,834,489
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
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	5,670,524
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009	6,589,960
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	5,670,524
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	4,870,086

Paragraph IV (Patent) Challenges for FRESENIUS KABI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Fresenius Kabi Drugs

Country	Patent Number	Estimated Expiration
Denmark	2626068
European Patent Office	2191807
European Patent Office	2243477
Denmark	1507502
Canada	2542408
Mexico	PA06004241
Brazil	PI1011630

Supplementary Protection Certificates for Fresenius Kabi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	132014902271575	Italy		PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
2666774	CA 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
0748320	SPC/GB08/021	United Kingdom		PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111
0658161	SPC/GB01/003	United Kingdom		PRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
1853250	37/2014	Austria		PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
0287150	96C0038	Belgium		PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406

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