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	LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	202231-001	Jun 24, 2011	AP	RX	Yes	Yes	9,168,239	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203183-001	Feb 26, 2015	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	210632-002	Apr 11, 2019		RX	Yes	Yes	11,135,190	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-006	Jan 16, 2020	AP	RX	Yes	Yes	9,248,229	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	MESNA	mesna	INJECTABLE;INTRAVENOUS	075811-001	Apr 26, 2001	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	065374-001	Aug 9, 2007	AP	RX	No	Yes		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075836-001	Dec 31, 2002		DISCN	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
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	5,834,489	⤷ Try a Trial
>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
2701720	CR 2022 00054	Denmark	⤷ Try a Trial	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
0186405	SPC/GB00/021	United Kingdom	⤷ Try a Trial	PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
1769785	C300521	Netherlands	⤷ Try a Trial	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1746976	C01746976/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
0430190	18/2005	Austria	⤷ Try a Trial	PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
0236940	97C0053	Belgium	⤷ Try a Trial	PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072
0275821	SPC/GB01/039	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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