Fresenius Kabi Usa Company Profile

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FRESENIUS KABI USA has three hundred and one 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-two supplementary protection certificates in seventeen countries.

International Patents:	129
US Patents:	23
Tradenames:	247
Ingredients:	184
NDAs:	301
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	FLUDARABINE PHOSPHATE	fludarabine phosphate	INJECTABLE;INJECTION	078544-001	Oct 15, 2007	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	075936-001	May 28, 2002	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	208418-002	Jun 15, 2017	AP	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	VALPROATE SODIUM	valproate sodium	INJECTABLE;INJECTION	076539-001	Jun 26, 2003	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	065375-001	Aug 9, 2007		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	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-004	Apr 30, 2009	6,589,960	⤷ Try a Trial
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	5,834,489	⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-005	Apr 30, 2009	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	020533-004	Sep 24, 1996	5,670,524	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ Subscribe	Oral Solution	5 mg/5mL	➤ Subscribe	2011-02-25

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	PA2013025,C1304992	Lithuania	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
0957929	SPC/GB06/021	United Kingdom	⤷ Try a Trial	PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
2768484	LUC00135	Luxembourg	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
0748228	11C0002	France	⤷ Try a Trial	PRODUCT NAME: MANNITOL; NAT. REGISTRATION NO/DATE: NL 34557 20080819; FIRST REGISTRATION: SE - 22708 20061020
0620232	44/2001	Austria	⤷ Try a Trial	PRODUCT NAME: CASPOFUNGIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE CASPOFUNGINACETAT; REGISTRATION NO/DATE: EU/01/196/001-003 20011024
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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