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Generated: September 24, 2017

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 sixteen approved drugs.

There are thirteen US patents protecting FRESENIUS KABI USA drugs and there have been two 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 six patent family members on FRESENIUS KABI USA drugs in twenty-three countries.

Summary for Applicant: Fresenius Kabi Usa

Patents:13
Tradenames:171
Ingredients:140
NDAs:216
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
FLUMAZENIL
flumazenil
INJECTABLE;INJECTION076955-002Oct 12, 2004APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
XYLOCAINE 4% PRESERVATIVE FREE
lidocaine hydrochloride
INJECTABLE;INJECTION010417-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
AZTREONAM
aztreonam
INJECTABLE;INJECTION065439-002Jun 18, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
XYLOCAINE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION006488-018Nov 13, 1986APRXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
MITOXANTRONE HYDROCHLORIDE
mitoxantrone hydrochloride
INJECTABLE;INJECTION077496-002Apr 11, 2006APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
IFOSFAMIDE
ifosfamide
INJECTABLE;INJECTION090181-001Sep 22, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION040278-001Sep 30, 1998APRXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
MANNITOL 25%
mannitol
INJECTABLE;INJECTION080677-001Approved Prior to Jan 1, 1982APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
MIDAZOLAM HYDROCHLORIDE
midazolam hydrochloride
INJECTABLE;INJECTION075154-001Jun 20, 2000APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride
INJECTABLE;INJECTION062663-003Jun 3, 1988APRXNoYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Fresenius Kabi Usa

Paragraph IV activity for FRESENIUS KABI USA drugs

Drugname Dosage Strength Tradename Submissiondate
levothyroxine sodium
for Injection200 mcg/vial
LEVOTHYROXINE SODIUM
5/1/2015
levothyroxine sodium
for Injection100 mcg/vial and 500 mcg/vial
LEVOTHYROXINE SODIUM
4/14/2015
hydromorphone hydrochloride
Tablets2 mg, 4 mg, and 8 mg
DILAUDID
8/5/2013
argatroban in sodium chloride
Injection1 mg/mL, 50 mL vials
ARGATROBAN
12/16/2011
hydromorphone hydrochloride
Injection10 mg/mL
DILAUDID-HP
11/4/2011
hydromorphone hydrochloride
Injection2 mg/mL
DILAUDID
6/22/2011
hydromorphone hydrochloride
Oral Solution5 mg/5mL
DILAUDID
2/25/2011
argatroban
Injection100 mg/mL, 2.5 mL vials
ARGATROBAN
9/24/2007
ropivacaine hydrochloride
Injection2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials
NAROPIN
11/13/2006

Non-Orange Book 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
9,545,473Packaging 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 Usa Drugs

Country Document Number Estimated Expiration
European Patent Office2301622► Subscribe
Hong Kong1215668► Subscribe
European Patent Office1233966► Subscribe
China104528165► Subscribe
European Patent Office2968729► Subscribe
Australia2004281535► Subscribe
Poland212919► Subscribe
Canada2487551► Subscribe
World Intellectual Property Organization (WIPO)03099191► Subscribe
Australia2014230836► 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 Usa Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90026-1Sweden► SubscribePRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT ELLER SOLVAT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720
2016 00019Denmark► SubscribePRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCATBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOSYRE, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ELLER ET ESTERPRODRUG DERAF; REG. NO/DATE: EU/1/15/1059 20151124
01C/030Belgium► SubscribePRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
60031Netherlands► SubscribePRODUCT NAME: DOXORUBICINESULFAAT VERKREGEN UIT DOXORUBICINEHYDROCHLORIDE EN AMMONIUMSULFAAT; REGISTRATION NO/DATE: EU/1/96/011/001 - EU/1/96/011/002 19960621
90064-1Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
06/030Ireland► SubscribePRODUCT NAME: TIGECYCLINE OR A PHARMACOLOGICALLY ACCEPTABLE ORGANIC OR INORGANIC SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/06/336/001 20060424
923Luxembourg► SubscribePRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
C/GB02/037United Kingdom► SubscribePRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
2004012,C0780390Lithuania► SubscribePRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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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 500+ biopharmaceutical companies globally:

Baxter
Citi
US Army
US Department of Justice
Covington
Merck
Queensland Health
Argus Health
Fish and Richardson
Daiichi Sankyo

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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ISSN: 2162-2639

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