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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Argus Health
Medtronic
Deloitte
Cerilliant
Harvard Business School
Covington
Federal Trade Commission
Fish and Richardson

Generated: February 18, 2018

DrugPatentWatch Database Preview

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 forty approved drugs.

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

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

Summary for Fresenius Kabi
International Patents:112
US Patents:14
Tradenames:184
Ingredients:152
NDAs:240

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 FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040279-002 Sep 30, 1998 AP RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 065374-002 Aug 9, 2007 AP RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa VINCRISTINE SULFATE vincristine sulfate INJECTABLE;INJECTION 076401-001 Oct 28, 2003 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 017029-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa PAMIDRONATE DISODIUM pamidronate disodium INJECTABLE;INJECTION 075773-001 May 6, 2002 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa GANCICLOVIR ganciclovir sodium INJECTABLE;INJECTION 090658-001 Jun 21, 2010 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa CLADRIBINE cladribine INJECTABLE;INJECTION 076571-001 Apr 22, 2004 AP RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa FUROSEMIDE furosemide INJECTABLE;INJECTION 018902-001 May 22, 1984 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa RIFAMPIN rifampin INJECTABLE;INJECTION 091181-001 Aug 21, 2014 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa ASTRAMORPH PF morphine sulfate INJECTABLE;INJECTION 071050-001 Oct 7, 1986 AP RX No No ➤ 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

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 020533-004 Sep 24, 1996 5,670,524 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 5,834,489 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 5,670,524 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 5,834,489 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 4,695,576 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 4,870,086 ➤ Try a Free Trial
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,714,520*PED ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 4,695,576 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 4,870,086 ➤ 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 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

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 ➤ Try a Free Trial
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for Fresenius Kabi Drugs

Supplementary Protection Certificates for Fresenius Kabi Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004017 Lithuania ➤ Try a Free Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
C0026 France ➤ Try a Free Trial PRODUCT NAME: RALTEGRAVIR OU L(UN DE SES SELS PHARMACEUTIQUEMENT ACCCEPTABLES EN PARTICULIER UN SEL DE POTASSIUM; REGISTRATION NO/DATE IN FRANCE: EU/1/07/436/001 DU 20071220; REGISTRATION NO/DATE AT EEC: EU/1/07/436/001 DU 20071220
C0012 France ➤ Try a Free Trial PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
70017 Netherlands ➤ Try a Free Trial PRODUCT NAME: TOPOTECAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, HYDRAAT OF SOLVAAT, IN HET BIJZONDER HET HYDROCHLORI DE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 - EU/1/96/027/002 19961112; FIRST REGISTRATION: CH IKS 53857 19961016
1353647/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
C0009 Belgium ➤ Try a Free Trial PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
99C0030 Belgium ➤ Try a Free Trial PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
2015 00072 Denmark ➤ Try a Free Trial PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
2013025,C1304992 Lithuania ➤ Try a Free Trial PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
073 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ACIDE BENZOIQUE 3-{6-{-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5-YL)CYCLOPROPANECARBONYL AMINO}-3-METHYLPYRIDIN-2-YL}, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN PRO-MEDICAMENT DE TYPE ESTER DE CELUI-CI; FIRST REGISTRATION DATE: 20151124
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:

US Army
Daiichi Sankyo
Citi
US Department of Justice
Chinese Patent Office
Dow
Fuji
Covington
Merck

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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