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Serving leading biopharmaceutical companies globally:

Cerilliant
QuintilesIMS
Deloitte
AstraZeneca
Covington
Cantor Fitzgerald
US Army
Fish and Richardson
Chinese Patent Office
Dow

Generated: December 13, 2017

DrugPatentWatch Database Preview

Fresenius Company Profile

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What is the competitive landscape for FRESENIUS, and what generic alternatives to FRESENIUS drugs are available?

FRESENIUS has two hundred and forty-seven approved drugs.

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

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

Summary for Fresenius

International Patents:129
US Patents:18
Tradenames:205
Ingredients:151
NDAs:247
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 MedclSODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERsodium chlorideINJECTABLE;INJECTION078177-001Apr 12, 2007APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi OncolMITOXANTRONE HYDROCHLORIDEmitoxantrone hydrochlorideINJECTABLE;INJECTION078606-002May 14, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-007Sep 24, 1996RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Fresenius Kabi UsaLEVOTHYROXINE SODIUMlevothyroxine sodiumPOWDER;INTRAVENOUS202231-001Jun 24, 2011APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Fresenius Kabi UsaEPIRUBICIN HYDROCHLORIDEepirubicin hydrochlorideINJECTABLE;INJECTION065408-001Oct 15, 2007APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaPAMIDRONATE DISODIUMpamidronate disodiumINJECTABLE;INJECTION076207-001May 17, 2002APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaMORPHINE SULFATEmorphine sulfateSOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-004Oct 30, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Fresenius Kabi UsaCARBOPLATINcarboplatinINJECTABLE;IV (INFUSION)077247-003Oct 21, 2004APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaMAGNESIUM SULFATE IN PLASTIC CONTAINERmagnesium sulfateINJECTABLE;INJECTION206485-003Mar 15, 2016APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaARGATROBANargatrobanINJECTABLE;INJECTION201811-001Mar 23, 2015APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Fresenius

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 MedclPHOSLOcalcium acetateCAPSULE;ORAL021160-001Apr 2, 2001► 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 MedclPHOSLO GELCAPScalcium acetateCAPSULE;ORAL021160-003Apr 2, 2001► Subscribe► Subscribe
Fresenius MedclPHOSLOcalcium acetateTABLET;ORAL019976-001Dec 10, 1990► Subscribe► Subscribe
Fresenius Kabi UsaNAROPINropivacaine hydrochlorideSOLUTION;INJECTION020533-001May 1, 1998► Subscribe► Subscribe
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Paragraph IV activity for FRESENIUS 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
calcium acetateOral Solution667 mg/5 mLPHOSLYRA12/5/2013
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
calcium acetateCapsulesEQ 169 mg calciumPHOSLO5/31/2005

Non-Orange Book Patents for Fresenius

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 Drugs

Country Document Number Estimated Expiration
Spain2309491► Subscribe
Japan2016512210► Subscribe
Norway328168► Subscribe
South Korea20090040340► Subscribe
Denmark1673135► Subscribe
Poland2922530► Subscribe
Australia2014230834► Subscribe
Japan2005527301► Subscribe
Hong Kong1081430► Subscribe
China204798475► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/031United Kingdom► SubscribePRODUCT NAME: GEMCITABINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY- ACCEPTABLE SALT; REGISTERED: NL RVG17854 19950327; UK 00006/0301 19951026; UK 00006/0302 19951026
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
0492Netherlands► SubscribePRODUCT NAME: AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
01/029Ireland► SubscribePRODUCT NAME: CASPOFUNGIN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024; PAEDIATRIC INV. PLAN: P/30/2008
C/GB08/018United Kingdom► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
C0052France► SubscribePRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
C/GB98/043United Kingdom► SubscribePRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512
00111Netherlands► SubscribePRODUCT NAME: MOXIFLOXACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER MOXIFLOXACINEHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 28118 RVG 28119 20021017; FIRST REGISTRATION: DE 45263.00.00 19990621
2015000111Germany► SubscribePRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728
C0041Belgium► SubscribePRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
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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 plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Covington
Cipla
Chubb
Healthtrust
Deloitte
Farmers Insurance
US Department of Justice
Dow

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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