Fresenius Company Profile

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FRESENIUS has three hundred and thirty-one approved drugs.

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

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

International Patents:	150
US Patents:	26
Tradenames:	284
Ingredients:	195
NDAs:	331
Patent Litigation for Fresenius:	See patent lawsuits for Fresenius
PTAB Cases with Fresenius as petitioner:	See PTAB cases with Fresenius as petitioner
PTAB Cases with Fresenius as patent owner:	See PTAB cases with Fresenius 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	VINBLASTINE SULFATE	vinblastine sulfate	INJECTABLE;INJECTION	089515-001	Apr 29, 1987		RX	No	Yes		⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	POLOCAINE	mepivacaine hydrochloride	INJECTABLE;INJECTION	089407-001	Dec 1, 1986	AP	RX	No	No		⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	MORPHINE SULFATE	morphine sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	204223-004	Oct 30, 2013		DISCN	Yes	No	9,192,608	⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	017029-020	Mar 31, 2011		RX	Yes	Yes		⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	SUMATRIPTAN SUCCINATE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	079242-001	Mar 2, 2009	AP	RX	No	No		⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	LEVOTHYROXINE SODIUM	levothyroxine sodium	SOLUTION;INTRAVENOUS	210632-002	Apr 11, 2019		RX	Yes	Yes	10,398,669	⤷ Subscribe	Y			⤷ Subscribe
>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	020533-001	May 1, 1998	4,870,086	⤷ Subscribe
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994	6,589,960	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	4,695,576	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	8,118,802	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	4,695,576	⤷ Subscribe
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627-002	Jun 11, 1996	5,908,869*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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	Capsules	EQ 169 mg calcium	➤ Subscribe	2005-05-31
➤ 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	Oral Solution	667 mg/5 mL	➤ Subscribe	2013-12-05
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Injection	2 mg/mL	➤ Subscribe	2011-06-22

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Country	Patent Number	Estimated Expiration
European Patent Office	2968132	⤷ Subscribe
San Marino	T201600452	⤷ Subscribe
European Patent Office	2922530	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2008011126	⤷ Subscribe
Brazil	112015022171	⤷ Subscribe
Norway	331003	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	2018/031	Ireland	⤷ Subscribe	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1827461	300930	Netherlands	⤷ Subscribe	PRODUCT NAME: CLADRIBINE; REGISTRATION NO/DATE: EU/1/17/1212 20170824
1259550	08C0052	France	⤷ Subscribe	PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
3347352	2290051-8	Sweden	⤷ Subscribe	PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
1635783	C300653	Netherlands	⤷ Subscribe	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2785706	LUC00158	Luxembourg	⤷ Subscribe	PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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