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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Colorcon
Citi
Cipla
Federal Trade Commission
Teva
Medtronic
Argus Health
AstraZeneca

Generated: October 15, 2018

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Fresenius Kabi Usa Company Profile

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What is the competitive landscape for FRESENIUS KABI USA, and what generic alternatives to FRESENIUS KABI USA drugs are available?

FRESENIUS KABI USA has two hundred and thirty-seven approved drugs.

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

Drugs and US Patents for Fresenius Kabi Usa

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 LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 088586-001 Jul 24, 1985 AP RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa CAFFEINE CITRATE caffeine citrate SOLUTION;ORAL 078002-001 Jan 31, 2008 AA RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa XYLOCAINE lidocaine hydrochloride INJECTABLE;INJECTION 006488-007 Approved Prior to Jan 1, 1982 AP RX Yes Yes ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089003-001 May 31, 1985 DISCN No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa TIGECYCLINE tigecycline POWDER;INTRAVENOUS 205645-001 Dec 1, 2016 AP RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa DEFEROXAMINE MESYLATE deferoxamine mesylate INJECTABLE;INJECTION 078718-002 Sep 15, 2009 AP RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa METHOTREXATE SODIUM methotrexate sodium INJECTABLE;INJECTION 040263-002 Feb 26, 1999 DISCN 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 Usa

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
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 5,670,524 ➤ Sign Up
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,714,520*PED ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 5,834,489 ➤ 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 USA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24

International Patents for Fresenius Kabi Usa Drugs

Country Document Number Estimated Expiration
European Patent Office 2376147 ➤ Sign Up
Australia 2004281535 ➤ Sign Up
Australia 1595701 ➤ Sign Up
European Patent Office 2191807 ➤ Sign Up
Canada 2542408 ➤ Sign Up
Germany 10348016 ➤ Sign Up
World Intellectual Property Organization (WIPO) 2014140097 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for Fresenius Kabi Usa Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013000046 Germany ➤ Sign Up PRODUCT NAME: 4-AMINOPYRIDIN ODER EIN DERIVAT DAVON, INSBESONDERE EIN SALZ, EIN SOLVAT ODER EINE PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
C/GB97/010 United Kingdom ➤ Sign Up PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
16/018 Ireland ➤ Sign Up PRODUCT NAME: 3-(6-((1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5- YL)CYCLOPROPANECARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID (LUMACAFTOR), OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER PRODRUG THEREOF; REGISTRATION NO/DATE: EU/1/15/1059 20151119
80045 Netherlands ➤ Sign Up PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
666 Luxembourg ➤ Sign Up PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2011 00031 Denmark ➤ Sign Up PRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720
00617 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
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:

Citi
McKinsey
Fish and Richardson
Cantor Fitzgerald
Johnson and Johnson
UBS
Chubb
Farmers Insurance
Fuji

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