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Serving leading biopharmaceutical companies globally:

Moodys
Cerilliant
McKinsey
Cipla
Queensland Health
Julphar
Covington
Chubb
Mallinckrodt
QuintilesIMS

Generated: October 21, 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-one 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 and two hundred and twenty-two supplementary protection certificates in twelve countries.

Summary for Applicant: Fresenius Kabi

International Patents:106
US Patents:13
Tradenames:176
Ingredients:145
NDAs:231
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
LEUCOVORIN CALCIUM PRESERVATIVE FREE
leucovorin calcium
INJECTABLE;INJECTION040286-001Feb 26, 1999RXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
DIPRIVAN
propofol
INJECTABLE;INJECTION019627-001Oct 2, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
PAMIDRONATE DISODIUM
pamidronate disodium
INJECTABLE;INJECTION075773-002May 6, 2002APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
KABIVEN IN PLASTIC CONTAINER
amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil
EMULSION;IV (INFUSION)200656-006Aug 25, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-005Oct 30, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Fresenius Kabi Usa
PENTAM
pentamidine isethionate
INJECTABLE;INJECTION019264-001Oct 16, 1984APRXYesYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
CAFFEINE CITRATE
caffeine citrate
SOLUTION;INTRAVENOUS077997-001Jul 20, 2007APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
METHYLPREDNISOLONE SODIUM SUCCINATE
methylprednisolone sodium succinate
INJECTABLE;INJECTION040612-001Aug 12, 2004APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride
INJECTABLE;INJECTION089556-001Apr 16, 1987RXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FAMOTIDINE PRESERVATIVE FREE
famotidine
INJECTABLE;INJECTION075813-001Apr 16, 2001APRXNoNo► 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
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
DIPRIVAN
propofol
INJECTABLE;INJECTION019627-002Jun 11, 1996► Subscribe► Subscribe
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
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-003May 1, 1998► 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
Hong Kong1085372► Subscribe
China100408013► Subscribe
Norway339635► Subscribe
Slovenia1673135► Subscribe
BrazilPI0408780► Subscribe
Australia1595701► Subscribe
Poland377727► Subscribe
European Patent Office1605891► Subscribe
Hong Kong1081430► Subscribe
South Korea20070007248► 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
C0003France► SubscribePRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
C0076France► SubscribePRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
C/GB09/024United Kingdom► SubscribePRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
0162Netherlands► SubscribePRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
2012000017Germany► SubscribePRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
90020-1Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
00722Netherlands► SubscribePRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
90027-1Sweden► SubscribePRODUCT NAME: AZTREONAMLYSIN; REG. NO/DATE: EU/1/09/543/01 20090921
56/2007Austria► SubscribePRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
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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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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Teva
Deloitte
Harvard Business School
US Department of Justice
McKinsey
Healthtrust
Federal Trade Commission
Novartis

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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