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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Teva
US Army
Chubb
Moodys
Colorcon
Healthtrust
Federal Trade Commission

Generated: April 20, 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 twenty-eight 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.

Summary for Fresenius Kabi Usa
International Patents:117
US Patents:15
Tradenames:181
Ingredients:148
NDAs:228

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 EPIRUBICIN HYDROCHLORIDE epirubicin hydrochloride INJECTABLE;INJECTION 065408-004 Oct 15, 2007 AP RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa IDARUBICIN HYDROCHLORIDE idarubicin hydrochloride INJECTABLE;INJECTION 065440-001 Aug 4, 2009 AP RX No No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa PERIKABIVEN IN PLASTIC CONTAINER amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil EMULSION;IV (INFUSION) 200656-002 Aug 25, 2014 RX Yes No ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040379-001 Nov 15, 2000 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 DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,731,356*PED ➤ Sign Up
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,908,869*PED ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 4,870,086 ➤ Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 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 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
9,072,655 Propofol formulations with non-reactive container closures ➤ Sign Up
9,072,656 Propofol formulations with non-reactive container closures ➤ Sign Up
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Sign Up
6,512,117 Hydromorphone and hydrocodone compositions and methods for their synthesis ➤ Sign Up
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
401 Luxembourg ➤ Sign Up PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
666 Luxembourg ➤ Sign Up PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
C0037 Belgium ➤ Sign Up PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
00071 Netherlands ➤ Sign Up PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
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:

Chubb
Citi
Express Scripts
Moodys
Healthtrust
Cerilliant
Baxter
McKinsey
UBS

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