Fresenius Kabi Company Profile

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FRESENIUS KABI has three hundred and fifteen approved drugs.

There are twenty-three US patents protecting FRESENIUS KABI drugs. There are three 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-seven supplementary protection certificates in seventeen countries.

International Patents:	129
US Patents:	23
Tradenames:	256
Ingredients:	190
NDAs:	315
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

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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	XYLOCAINE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	016801-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%	potassium chloride; sodium chloride	INJECTABLE;INJECTION	212347-002	Sep 17, 2020	AP	RX	No	No		⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	CAFFEINE CITRATE	caffeine citrate	SOLUTION;INTRAVENOUS	077997-001	Jul 20, 2007	AP	RX	No	No		⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	HEPARIN SODIUM IN PLASTIC CONTAINER	heparin sodium	INJECTABLE;INJECTION	017029-013	Dec 5, 1985	AP	RX	Yes	Yes		⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	4,870,086	⤷ Subscribe
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994	6,589,960	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	4,695,576	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	8,118,802	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ Subscribe	Oral Solution	5 mg/5mL	➤ Subscribe	2011-02-25
➤ Subscribe	Tablets	2 mg, 4 mg, and 8 mg	➤ Subscribe	2013-08-05
➤ Subscribe	for Injection	100 mcg/vial and 500 mcg/vial	➤ Subscribe	2015-04-14
➤ Subscribe	Injection	2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials	➤ Subscribe	2006-11-13
➤ Subscribe	Injection	2 mg/mL, 200 mL	➤ Subscribe	2015-09-03
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Injection	2 mg/mL	➤ Subscribe	2011-06-22
➤ Subscribe	Injection	10 mg/mL	➤ Subscribe	2011-11-04
➤ Subscribe	for Injection	200 mcg/vial	➤ Subscribe	2015-05-01
➤ Subscribe	Injection	2 mg/mL, 100 mL	➤ Subscribe	2015-01-30

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	2018/031	Ireland	⤷ Subscribe	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1827461	300930	Netherlands	⤷ Subscribe	PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1259550	08C0052	France	⤷ Subscribe	PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
3347352	2290051-8	Sweden	⤷ Subscribe	PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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