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Serving leading biopharmaceutical companies globally:

Fuji
Julphar
Daiichi Sankyo
Dow
Queensland Health
Baxter
Teva
US Department of Justice
Argus Health
Citi

Generated: October 23, 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 seventeen 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 and two hundred and nine supplementary protection certificates in twelve countries.

Summary for Applicant: Fresenius Kabi Usa

International Patents:106
US Patents:13
Tradenames:171
Ingredients:140
NDAs:217
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
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-006Sep 24, 1996APRXYesNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
TERBUTALINE SULFATE
terbutaline sulfate
INJECTABLE;INJECTION076887-001May 26, 2004APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
lidocaine hydrochloride
INJECTABLE;INJECTION088586-001Jul 24, 1985APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
POLOCAINE
mepivacaine hydrochloride
INJECTABLE;INJECTION089407-001Dec 1, 1986APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
XYLOCAINE W/ EPINEPHRINE
epinephrine; lidocaine hydrochloride
INJECTABLE;INJECTION006488-018Nov 13, 1986APRXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
ASTRAMORPH PF
morphine sulfate
INJECTABLE;INJECTION071051-001Oct 7, 1986APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
PHENYTOIN SODIUM
phenytoin sodium
INJECTABLE;INJECTION089003-001May 31, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
LEVOTHYROXINE SODIUM
levothyroxine sodium
POWDER;INTRAVENOUS202231-002Jun 24, 2011APRXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
DILAUDID-HP
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-002Aug 4, 1994DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
BLEOMYCIN SULFATE
bleomycin sulfate
INJECTABLE;INJECTION065185-001Jan 28, 2008APRXNoYes► 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;INJECTION020533-004Sep 24, 1996► 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
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
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 1996► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 1996► Subscribe► Subscribe
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
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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
Japan4886953► Subscribe
Japan2006521124► Subscribe
Austria469630► Subscribe
Canada2854796► Subscribe
Norway20062091► Subscribe
Australia1595701► Subscribe
Denmark1673135► Subscribe
Spain2405262► Subscribe
European Patent Office2968132► Subscribe
European Patent Office1673135► 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
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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
C0038Belgium► SubscribePRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
C/GB96/057United Kingdom► SubscribePRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112
2015 00072Denmark► SubscribePRODUCT 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
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
C/GB12/028United Kingdom► SubscribePRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
C/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
C0021France► SubscribePRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
C/GB11/045United 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
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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:

Dow
Accenture
US Department of Justice
Healthtrust
Express Scripts
Deloitte
Fish and Richardson
Argus Health
Federal Trade Commission
QuintilesIMS

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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