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 seven 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-two supplementary protection certificates in seventeen countries.

Summary for Fresenius Kabi

International Patents:	129
US Patents:	23
Tradenames:	248
Ingredients:	185
NDAs:	307
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	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	203629-003	Sep 18, 2018	AP	RX	Yes	Yes
Fresenius Kabi Usa	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	090799-001	Jul 25, 2011	AP	RX	No	No
Fresenius Kabi Usa	CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	064170-002	Mar 18, 1998		DISCN	No	No
Fresenius Kabi Usa	OXACILLIN SODIUM	oxacillin sodium	INJECTABLE;INJECTION	206198-001	Jul 20, 2020	AP	RX	No	No
Fresenius Kabi Usa	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065012-002	Jul 3, 2000		DISCN	No	No
Fresenius Kabi Usa	MORPHINE SULFATE	morphine sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	204223-003	Oct 30, 2013		RX	Yes	Yes	9,072,781		Y
Fresenius Kabi Usa	SENSORCAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	070968-001	Oct 13, 1987	AP	RX	No	No

Expired US Patents for Fresenius Kabi

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 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
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	6,589,960
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	4,870,086

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
European Patent Office	2301622
Poland	1673135
Australia	2004281535
European Patent Office	2968729
World Intellectual Property Organization (WIPO)	2004084793
Hong Kong	1089080
Japan	2012510330

Supplementary Protection Certificates for Fresenius Kabi 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