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Serving 500+ biopharmaceutical companies globally:

UBS
US Department of Justice
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Fuji
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Generated: July 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
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-005Oct 30, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
DILAUDID
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-005Apr 30, 2009APRXYesYes► Subscribe► SubscribeYY ► Subscribe
Fresenius Kabi Usa
CEFTRIAXONE
ceftriaxone sodium
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS065245-002Feb 15, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION075015-001Apr 30, 1998APRXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
HEPARIN SODIUM
heparin sodium
INJECTABLE;INJECTION206552-001Jun 10, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Fresenius Kabi Usa

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-001May 1, 1998► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-003May 1, 1998► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi Usa
DIPRIVAN
propofol
INJECTABLE;INJECTION019627-002Jun 11, 1996► Subscribe► Subscribe
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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
South Korea20070007248► Subscribe
MexicoPA05010292► Subscribe
Austria500257► Subscribe
Germany502004008025► Subscribe
South Africa200409019► 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
C/GB11/026United Kingdom► SubscribePRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
678Luxembourg► SubscribePRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
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
C/GB96/051United Kingdom► SubscribePRODUCT NAME: (S)-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE MONOHYDRATE (GENERIC NAME: ROPIVACAINE MONOHYDROCHLORIDE MONOHYDRATE); REGISTERED: SE 12319 19950915; SE 12322 19950915; SE 12323 19950915; UK 0017/0375 19960517; UK 0017/0376 19960517; UK 0017/0377 19960517; UK 0017/0378 19960517
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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:

Covington
Cerilliant
McKinsey
Fuji
US Army
Boehringer Ingelheim
Cantor Fitzgerald
Argus Health
Dow
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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