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Serving leading biopharmaceutical companies globally:

McKinsey
Cantor Fitzgerald
Express Scripts
Boehringer Ingelheim
Fish and Richardson
UBS
Daiichi Sankyo
Mallinckrodt
Fuji
Medtronic

Generated: December 12, 2017

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 thirty-three approved drugs.

There are thirteen US patents protecting FRESENIUS KABI drugs and there have been four 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 seven patent family members on FRESENIUS KABI drugs in twenty-four countries and two hundred and twenty-four supplementary protection certificates in twelve countries.

Summary for Fresenius Kabi

International Patents:107
US Patents:13
Tradenames:178
Ingredients:147
NDAs:233
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-006Sep 24, 1996APRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Fresenius Kabi UsaCARBOPLATINcarboplatinINJECTABLE;IV (INFUSION)077247-001Oct 21, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaXYLOCAINE W/ EPINEPHRINEepinephrine; lidocaine hydrochlorideINJECTABLE;INJECTION006488-012Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaMORPHINE SULFATEmorphine sulfateSOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-001Oct 30, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Fresenius Kabi UsaFLUCONAZOLE IN SODIUM CHLORIDE 0.9%fluconazoleINJECTABLE;INJECTION076145-002Jul 29, 2004APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaAZTREONAMaztreonamINJECTABLE;INJECTION065439-002Jun 18, 2010APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaCARBOPLATINcarboplatinINJECTABLE;IV (INFUSION)077266-002Feb 15, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaCLINDAMYCIN PHOSPHATEclindamycin phosphateINJECTABLE;INJECTION065347-001May 9, 2007APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaROCURONIUM BROMIDErocuronium bromideINJECTABLE;INJECTION078651-001Dec 29, 2008APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaMIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEmidazolam hydrochlorideINJECTABLE;INJECTION203460-001Aug 22, 2014APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Fresenius Kabi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-004Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-004Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-001May 1, 1998► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-005Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-003May 1, 1998► Subscribe► Subscribe
Fresenius Kabi UsaDIPRIVANpropofolINJECTABLE;INJECTION019627-002Jun 11, 1996► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-001May 1, 1998► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-004Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-005Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-003May 1, 1998► Subscribe► Subscribe
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Paragraph IV activity for FRESENIUS KABI drugs

Drugname Dosage Strength Tradename Submissiondate
ropivacaine hydrochlorideInjection2 mg/mL, 200 mLNAROPIN9/3/2015
levothyroxine sodiumfor Injection200 mcg/vialLEVOTHYROXINE SODIUM5/1/2015
levothyroxine sodiumfor Injection100 mcg/vial and 500 mcg/vialLEVOTHYROXINE SODIUM4/14/2015
ropivacaine hydrochlorideInjection2 mg/mL, 100 mLNAROPIN1/30/2015
hydromorphone hydrochlorideTablets2 mg, 4 mg, and 8 mgDILAUDID8/5/2013
argatroban in sodium chlorideInjection1 mg/mL, 50 mL vialsARGATROBAN12/16/2011
hydromorphone hydrochlorideInjection10 mg/mLDILAUDID-HP11/4/2011
hydromorphone hydrochlorideInjection2 mg/mLDILAUDID6/22/2011
hydromorphone hydrochlorideOral Solution5 mg/5mLDILAUDID2/25/2011
argatrobanInjection100 mg/mL, 2.5 mL vialsARGATROBAN9/24/2007
ropivacaine hydrochlorideInjection2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vialsNAROPIN11/13/2006

Non-Orange Book 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► Subscribe
9,545,473Packaging system for oxygen-sensitive drugs► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Fresenius Kabi Drugs

Country Document Number Estimated Expiration
Japan2006521124► Subscribe
MexicoPA04011784► Subscribe
Poland377727► Subscribe
Spain2309491► Subscribe
Austria407653► Subscribe
MexicoPA05010292► Subscribe
MexicoPA02004678► Subscribe
India1252DEN2012► Subscribe
Japan4684233► Subscribe
Poland373496► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Fresenius Kabi Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
02/028Ireland► SubscribePRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
C/GB98/042United Kingdom► SubscribePRODUCT NAME: 2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT AND/OR OPTIONALLY IN THE FORM OF AN ENANTIOMER, IN PARTICULAR (S)(+)-2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3; REGISTERED: UK EU/1/98/076/001 19980817; UK EU/1/98/076/002 19980817; UK EU/1/98/076/003 19980817; UK EU/1/98/076/004 19980817; UK EU/1/98/076/005 19980817; UK EU/1/98/076/006 19980817; UK EU/1/98/076/019 19980817; UK EU/1/98/076/020 19980817; UK EU/1/98/076/021 19980817; UK EU/1/98/076/013 19980817; UK EU/1/98/076/014 19980817; UK EU/1/98/076/015 19980817; UK EU/1/98/076/016 19980817; UK EU/1/98/076/017 19980817; UK EU/1/98/
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
/2015Austria► SubscribePRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
C/GB01/002United Kingdom► SubscribePRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
C/GB05/042United Kingdom► SubscribePRODUCT NAME: MESYLATE, ESYLATE OR SULFATE SALTS OF N-PROPARGYL-1(R)-AMINOINDAN (RASAGILINE); REGISTERED: UK EU/1/04/304/001 20050221; UK EU/1/04/304/002 20050221; UK EU/1/04/304/003 20050221; UK EU/1/04/304/004 20050221; UK EU/1/04/304/005 20050221; UK EU/1/04/304/006 20050221; UK EU/1/04/304/007 20050221
00244Netherlands► SubscribePRODUCT: TIGECYCLINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX, IN HET BIJZONDER TIGECYCLINE; FIRST REGISTRATION, DATE: EU/1/06/336/001, 20060424
2013025,C1304992Lithuania► SubscribePRODUCT 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
C/GB03/033United Kingdom► SubscribePRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving leading biopharmaceutical companies globally:

McKesson
Julphar
Covington
Boehringer Ingelheim
Fish and Richardson
Chubb
Cantor Fitzgerald
Medtronic
Deloitte
Baxter

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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