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 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-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	POLYMYXIN B SULFATE	polymyxin b sulfate	INJECTABLE;INJECTION	065372-001	Jan 10, 2008	AP	RX	No	No		⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-001	Oct 2, 1989		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	040279-001	Sep 30, 1998	AP	RX	No	No		⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	088586-003	Approved Prior to Jan 1, 1982	AP	RX	No	No		⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	215371-001	Jun 8, 2022	AP	RX	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
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	8,118,802	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	2015/071	Ireland	⤷ Sign Up	PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
0496835	C960031	Netherlands	⤷ Sign Up	PRODUCT NAME: DOXORUBICINESULFAAT VERKREGEN UIT DOXORUBICINEHYDROCHLORIDE EN AMMONIUMSULFAAT; REGISTRATION NO/DATE: EU/1/96/011/001 - EU/1/96/011/002 19960621
1304992	2013/044	Ireland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1534313	300784	Netherlands	⤷ Sign Up	PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
0383579	19675028	Germany	⤷ Sign Up	PRODUCT NAME: REMIFENTANIL SOWIE PHARMAZEUTISCH ANNEHMBARE SAEUREADDITIONSSALZE DAVON, EINSCHLIESSLICH REMIFENTANILHYDROCHLORID; REGISTRATION NO/DATE: 36335.00.00 36335.01.00 36335.02.00 19960517
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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