Fresenius Kabi Company Profile

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	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	040278-002	Sep 30, 1998	AP	RX	No	Yes
Fresenius Kabi Usa	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	074893-002	Dec 19, 1997	AO	RX	No	No
Fresenius Kabi Usa	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065245-001	Feb 15, 2006		DISCN	No	No
Fresenius Kabi Usa	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	079240-002	Sep 18, 2009		DISCN	No	No
Fresenius Kabi Usa	MITOXANTRONE HYDROCHLORIDE	mitoxantrone hydrochloride	INJECTABLE;INJECTION	077496-003	Apr 11, 2006	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	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	4,695,576
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	5,834,489
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	5,834,489
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	8,118,802

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
Spain	2693123
European Patent Office	3143988
Hong Kong	1208015
China	1867375
Canada	2902346

Supplementary Protection Certificates for Fresenius Kabi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748228	SPC/GB11/004	United Kingdom		PRODUCT NAME: MANNITOL; REGISTERED: SE 22708 20061020; UK PL 27944/0001-0001 20071218
0321122	2/1997	Austria		PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
2785706	2020C/516	Belgium		PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
1746976	2017/029	Ireland		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
1392714	23/2017	Austria		PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; REGISTRATION NO/DATE: EU/1/16/1139 20161212

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