Fresenius Kabi Usa Company Profile

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FRESENIUS KABI USA has three hundred and three approved drugs.

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

International Patents:	129
US Patents:	23
Tradenames:	252
Ingredients:	186
NDAs:	303
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	CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	064169-001	Aug 14, 1998		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	VINORELBINE TARTRATE	vinorelbine tartrate	INJECTABLE;INJECTION	076849-001	Apr 18, 2005		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	KANAMYCIN SULFATE	kanamycin sulfate	INJECTABLE;INJECTION	065111-002	Dec 17, 2002		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-010	Jan 4, 2011	AP	RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	XYLOCAINE 1.5% W/ DEXTROSE 7.5%	lidocaine hydrochloride	INJECTABLE;SPINAL	016297-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	208129-002	Nov 29, 2018	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
>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	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994	6,589,960	⤷ Try a Trial
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	8,118,802	⤷ Try a Trial
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-006	Sep 24, 1996	8,118,802	⤷ Try a Trial
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	5,908,869*PED	⤷ Try a Trial
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	5,670,524	⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	6,589,960	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0206283	C980016	Netherlands	⤷ Try a Trial	PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
1441735	2008/010	Ireland	⤷ Try a Trial	PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
2203431	CR 2015 00014	Denmark	⤷ Try a Trial	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2377536	2013/024	Ireland	⤷ Try a Trial	PRODUCT NAME: 4-AMINOPYRIDINE (FAMPRIDINE) OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/11/699/001-EU/1/22/699-002 20110720
1732548	C300515	Netherlands	⤷ Try a Trial	PRODUCT NAME: 4-AMINOPYRIDINE EN DERIVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
2340828	PA2021502	Lithuania	⤷ Try a Trial	PRODUCT NAME: SAKUBITRILAS/VALSARTANAS, KAIP SAKUBITRILO VALSARTANO NATRIO DRUSKOS KOMPLEKSAS, T.Y. (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINAS)((2R,4S)-5-BIFENIL-4-IL-4-(3-KARBOKSI-PROPIONILAMINO)-2-METIL-PENTANO RUGSTIES ETILO ESTERIS)NA3; REGISTRATION NO/DATE: EU/1/15/1058 20151119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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