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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
QuintilesIMS
Moodys
US Department of Justice
Farmers Insurance
Dow
Harvard Business School
Baxter
Argus Health

Generated: June 22, 2018

DrugPatentWatch Database Preview

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-one approved drugs.

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

There are one hundred and seventeen patent family members on FRESENIUS KABI USA drugs in twenty-four countries and two hundred and thirty-seven supplementary protection certificates in twelve countries.

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 PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080618-001 Approved Prior to Jan 1, 1982 AP RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa MILRINONE LACTATE milrinone lactate INJECTABLE;INJECTION 075936-001 May 28, 2002 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa ARGATROBAN argatroban INJECTABLE;INJECTION 201811-001 Mar 23, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa XYLOCAINE lidocaine hydrochloride INJECTABLE;INJECTION 006488-010 Approved Prior to Jan 1, 1982 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for Fresenius Kabi Usa

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,908,869*PED ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 5,670,524 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 4,870,086 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 5,670,524 ➤ Try a Free Trial
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 Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Oral Solution 5 mg/5mL ➤ Subscribe 2011-02-25
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Tablets 2 mg, 4 mg, and 8 mg ➤ Subscribe 2013-08-05
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 2 mg/mL, 200 mL ➤ Subscribe 2015-09-03
➤ 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 10 mg/mL ➤ Subscribe 2011-11-04
➤ Subscribe Injection 2 mg/mL ➤ Subscribe 2011-06-22
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 2 mg/mL, 100 mL ➤ Subscribe 2015-01-30

Non-Orange Book US Patents for Fresenius Kabi Usa

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,072,656 Propofol formulations with non-reactive container closures ➤ Try a Free Trial
6,512,117 Hydromorphone and hydrocodone compositions and methods for their synthesis ➤ Try a Free Trial
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Try a Free Trial
9,072,655 Propofol formulations with non-reactive container closures ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Fresenius Kabi Usa Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
16/018 Ireland ➤ Try a Free Trial 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
C0038 Belgium ➤ Try a Free Trial PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
C0033 France ➤ Try a Free Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
0482 Netherlands ➤ Try a Free Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
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.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Dow
Express Scripts
Chubb
Merck
Fish and Richardson
Deloitte
Argus Health
Healthtrust

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