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Serving leading biopharmaceutical companies globally:

Citi
Julphar
Boehringer Ingelheim
McKinsey
Colorcon
QuintilesIMS
Cipla
Teva
Novartis
Harvard Business School

Generated: January 19, 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 nineteen approved drugs.

There are thirteen US patents protecting FRESENIUS KABI USA drugs and there have been four Paragraph IV challenges on FRESENIUS KABI USA drugs in the past three years. There are two tentative approvals on FRESENIUS KABI USA drugs.

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

Summary for Fresenius Kabi Usa
International Patents:108
US Patents:13
Tradenames:173
Ingredients:142
NDAs:219

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 CYTARABINE cytarabine INJECTABLE;INJECTION 076512-001 Jan 15, 2004 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa CHLORAMPHENICOL SODIUM SUCCINATE chloramphenicol sodium succinate INJECTABLE;INJECTION 062365-001 Aug 25, 1982 RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071050-001 Oct 7, 1986 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride INJECTABLE;INJECTION 075826-001 Aug 31, 2001 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa VIBISONE cyanocobalamin INJECTABLE;INJECTION 080557-003 Approved Prior to Jan 1, 1982 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa MAGNESIUM SULFATE magnesium sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 019316-003 Jan 29, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-001 Oct 30, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Fresenius Kabi Usa CALCITRIOL calcitriol INJECTABLE;INJECTION 075836-001 Dec 31, 2002 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 088400-001 Jan 16, 1984 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride INJECTABLE;SPINAL 071202-001 Apr 15, 1987 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 ➤ Subscribe ➤ Subscribe
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 2 mg/mL, 200 mL ➤ Subscribe 9/3/2015
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 5/1/2015
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 4/14/2015
➤ Subscribe Injection 2 mg/mL, 100 mL ➤ Subscribe 1/30/2015
➤ Subscribe Tablets 2 mg, 4 mg, and 8 mg ➤ Subscribe 8/5/2013
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 12/16/2011
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 11/4/2011
➤ Subscribe Injection 2 mg/mL ➤ Subscribe 6/22/2011
➤ Subscribe Oral Solution 5 mg/5mL ➤ Subscribe 2/25/2011
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 9/24/2007
➤ Subscribe Injection 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials ➤ Subscribe 11/13/2006

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
6,512,117 Hydromorphone and hydrocodone compositions and methods for their synthesis ➤ Subscribe
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Fresenius Kabi Usa Drugs

Supplementary Protection Certificates for Fresenius Kabi Usa Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0162 Netherlands ➤ Subscribe PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
2011 00031 Denmark ➤ Subscribe PRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720
C0038 Belgium ➤ Subscribe PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
C/GB03/034 United Kingdom ➤ Subscribe PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313
C0008 Belgium ➤ Subscribe PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
C0041 France ➤ Subscribe PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
80016 Netherlands ➤ Subscribe PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
90018-5 Sweden ➤ Subscribe PRODUCT NAME: 3-6-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5- YL)CYCLOPROPANECARBONYLAMINO-3-METHYLPYRIDIN-2-YLBENZOIC ACID, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER THEREOF.; REG. NO/DATE: EU/1/15/1059 20151124
C0005 Belgium ➤ Subscribe PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
00071 Netherlands ➤ Subscribe 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 leading biopharmaceutical companies globally:

Covington
Julphar
Teva
McKesson
Fuji
Argus Health
McKinsey
Federal Trade Commission
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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