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QuintilesIMS
Fuji
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US Department of Justice
US Army
Baxter
Dow
Mallinckrodt
Deloitte
Julphar

Generated: August 17, 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 approved drugs.

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

Summary for Applicant: Fresenius Kabi

Patents:13
Tradenames:176
Ingredients:145
NDAs:230
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
DACARBAZINE
dacarbazine
INJECTABLE;INJECTION075371-002Aug 27, 1999APRXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-002Oct 30, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
SUMATRIPTAN SUCCINATE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS079240-001Sep 18, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
ASTRAMORPH PF
morphine sulfate
INJECTABLE;INJECTION071050-001Oct 7, 1986APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
PERIKABIVEN IN PLASTIC CONTAINER
amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil
EMULSION;IV (INFUSION)200656-003Aug 25, 2014RXYesNo► 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 Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-001May 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
DIPRIVAN
propofol
INJECTABLE;INJECTION019627-002Jun 11, 1996► 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 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

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
Portugal1605891► Subscribe
Germany502004008025► Subscribe
China100408013► Subscribe
Japan2006521124► Subscribe
Canada2389193► 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
C0042France► SubscribePRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917
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
0810Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIURA (3-((LS,3R)-L-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-L-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-ETHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
C0009Belgium► SubscribePRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
/2014Austria► SubscribePRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
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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:

Cipla
Queensland Health
Teva
Merck
Farmers Insurance
Julphar
Dow
Federal Trade Commission
Boehringer Ingelheim
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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