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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Argus Health
QuintilesIMS
UBS
Johnson and Johnson
Cipla
Farmers Insurance
Chinese Patent Office
Boehringer Ingelheim

Generated: October 15, 2018

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Fresenius Kabi Company Profile

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What is the competitive landscape for FRESENIUS KABI, and when can generic versions of FRESENIUS KABI drugs launch?

FRESENIUS KABI has two hundred and fifty-three approved drugs.

There are seventeen US patents protecting FRESENIUS KABI drugs. There are two tentative approvals on FRESENIUS KABI drugs.

Drugs and US Patents for Fresenius Kabi

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 HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 087329-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 018304-005 Sep 2, 1983 AP RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE midazolam hydrochloride INJECTABLE;INJECTION 203460-001 Aug 22, 2014 AP RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 203629-001 Jan 8, 2015 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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Expired US Patents for Fresenius Kabi

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 4,695,576 ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 4,695,576 ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 5,670,524 ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 4,695,576 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for FRESENIUS KABI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 2 mg/mL, 100 mL ➤ Subscribe 2015-01-30

Supplementary Protection Certificates for Fresenius Kabi Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0673 Netherlands ➤ Sign Up PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
C/GB09/024 United Kingdom ➤ Sign Up PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
2016000038 Germany ➤ Sign Up PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
00117 Netherlands ➤ Sign Up PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
Julphar
Teva
US Department of Justice
Chinese Patent Office
Argus Health
AstraZeneca
Fish and Richardson

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