FRESENIUS KABI USA Company Profile

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FRESENIUS KABI USA has three hundred and nine approved drugs.

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

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

International Patents:	129
US Patents:	23
Tradenames:	255
Ingredients:	189
NDAs:	309
Patent Litigation for FRESENIUS KABI USA:	See patent lawsuits for FRESENIUS KABI USA
PTAB Cases with FRESENIUS KABI USA as petitioner:	See PTAB cases with FRESENIUS KABI USA as petitioner
PTAB Cases with FRESENIUS KABI USA as patent owner:	See PTAB cases with FRESENIUS KABI USA 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	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	208418-001	Jun 15, 2017	AP	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	GENTAMICIN SULFATE	gentamicin sulfate	INJECTABLE;INJECTION	062366-002	Feb 6, 1986	AP	RX	No	Yes		⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	dextrose; sodium chloride	INJECTABLE;INJECTION	211276-001	Sep 15, 2020	AP	RX	No	No		⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	090181-001	Sep 22, 2009		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>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	020533-004	Sep 24, 1996	5,670,524	⤷ Sign Up
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009	6,589,960	⤷ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	8,162,915	⤷ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	5,834,489	⤷ Sign Up
>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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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004084793	⤷ Sign Up
Germany	10223560	⤷ Sign Up
Australia	2004224795	⤷ Sign Up
European Patent Office	1507502	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	13C0055	France	⤷ Sign Up	PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
2203431	15C0013	France	⤷ Sign Up	PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2203431	1590018-6	Sweden	⤷ Sign Up	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2768484	CR 2019 00051	Denmark	⤷ Sign Up	PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.