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	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	207310-001	Sep 19, 2017	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	206485-001	Mar 15, 2016	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	NESACAINE-MPF	chloroprocaine hydrochloride	INJECTABLE;INJECTION	009435-004	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	CALCITRIOL	calcitriol	INJECTABLE;INJECTION	075836-002	Dec 31, 2002		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	076887-001	May 26, 2004	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	017029-004	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes		⤷ 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	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	4,695,576	⤷ Try a Trial
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998	5,834,489	⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-002	Aug 4, 1994	6,589,960	⤷ Try a Trial
Fresenius Kabi Usa	DILAUDID-HP	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-001	Jan 11, 1984	6,589,960	⤷ 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	4,870,086	⤷ 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
2822954	1890030-8	Sweden	⤷ Try a Trial	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
1853250	37/2014	Austria	⤷ Try a Trial	PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
0383579	97C0029	Belgium	⤷ Try a Trial	PRODUCT NAME: REMIFENTANILUM HYDROCHLORIDUM (= REMIFENTANILUM BASIS); NAT. REGISTRATION NO/DATE: 725 IS 146 F 12 19970408; FIRST REGISTRATION: DE 36.335.00.00 19960517
0350733	SPC/GB03/034	United Kingdom	⤷ Try a Trial	PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313
2822954	18C1035	France	⤷ Try a Trial	PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0480717	98C0025	Belgium	⤷ Try a Trial	PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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