Fresenius Kabi Company Profile

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FRESENIUS KABI has three hundred and seven approved drugs.

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

There are one hundred and twenty-nine patent family members on FRESENIUS KABI drugs in twenty-five countries and four hundred and sixty-two supplementary protection certificates in seventeen countries.

International Patents:	129
US Patents:	23
Tradenames:	248
Ingredients:	185
NDAs:	307
Patent Litigation for Fresenius Kabi:	See patent lawsuits for Fresenius Kabi
PTAB Cases with Fresenius Kabi as petitioner:	See PTAB cases with Fresenius Kabi as petitioner
PTAB Cases with Fresenius Kabi as patent owner:	See PTAB cases with Fresenius Kabi 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	MORPHINE SULFATE	morphine sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	204223-002	Oct 30, 2013		RX	Yes	Yes	9,072,781	⤷ Try a Trial	Y			⤷ Try a Trial
Fresenius Kabi Usa	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ondansetron hydrochloride	INJECTABLE;INJECTION	076972-001	Dec 26, 2006	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	213523-002	Mar 9, 2021	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	XYLOCAINE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	016801-003	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	POLOCAINE-MPF	mepivacaine hydrochloride	INJECTABLE;INJECTION	089409-001	Dec 1, 1986	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	NEBUPENT	pentamidine isethionate	FOR SOLUTION;INHALATION	019887-001	Jun 15, 1989	AN	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	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
Fresenius Kabi Usa	DILAUDID	hydromorphone hydrochloride	INJECTABLE;INJECTION	019034-003	Apr 30, 2009	6,589,960	⤷ 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
2158901	122018000044	Germany	⤷ Try a Trial	PRODUCT NAME: AZTREONAMIYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
2805723	LUC00064	Luxembourg	⤷ Try a Trial	PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
2785706	122020000046	Germany	⤷ Try a Trial	PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
2957286	300962	Netherlands	⤷ Try a Trial	PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
0473687	SPC/GB98/030	United Kingdom	⤷ Try a Trial	PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
2340828	122021000003	Germany	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIPHENYL-4-YL)-METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA 3 * X H 2 0, WORIN X 0 BIS 3 IST; REGISTRATION NO/DATE: EU/1/15/1058 20151119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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