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Serving leading biopharmaceutical companies globally:

Novartis
US Department of Justice
Teva
Cipla
US Army
Mallinckrodt
Argus Health
Citi
Cerilliant
Colorcon

Generated: October 18, 2017

DrugPatentWatch Database Preview

Fresenius Company Profile

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What is the competitive landscape for FRESENIUS, and what generic alternatives to FRESENIUS drugs are available?

FRESENIUS has two hundred and forty-five approved drugs.

There are eighteen US patents protecting FRESENIUS drugs and there have been two Paragraph IV challenges on FRESENIUS drugs in the past three years. There are two tentative approvals on FRESENIUS drugs.

There are one hundred and twenty-eight patent family members on FRESENIUS drugs in twenty-six countries and two hundred and twenty-two supplementary protection certificates in twelve countries.

Summary for Applicant: Fresenius

International Patents:128
US Patents:18
Tradenames:203
Ingredients:149
NDAs:245
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
LEVOTHYROXINE SODIUM
levothyroxine sodium
POWDER;INTRAVENOUS202231-001Jun 24, 2011APRXYesYes► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
TIGECYCLINE
tigecycline
POWDER;IV (INFUSION)205645-001Dec 1, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
lidocaine hydrochloride
INJECTABLE;INJECTION088586-001Jul 24, 1985APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
lidocaine hydrochloride
INJECTABLE;INJECTION080404-003Approved 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
CHORIONIC GONADOTROPIN
gonadotropin, chorionic
INJECTABLE;INJECTION017067-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
DILAUDID-HP
hydromorphone hydrochloride
INJECTABLE;INJECTION019034-002Aug 4, 1994DISCNNoNo► Subscribe► SubscribeY ► 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
Fresenius Kabi Usa
FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride
INJECTABLE;INJECTION089556-001Apr 16, 1987RXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
HEPARIN SODIUM
heparin sodium
INJECTABLE;INJECTION017029-004Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Fresenius

Paragraph IV activity for FRESENIUS 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
calcium acetate
Oral Solution667 mg/5 mL
PHOSLYRA
12/5/2013
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
calcium acetate
CapsulesEQ 169 mg calcium
PHOSLO
5/31/2005

Non-Orange Book Patents for Fresenius

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 Drugs

Country Document Number Estimated Expiration
Hong Kong1202815► Subscribe
Slovenia1507502► Subscribe
China204798475► Subscribe
CroatiaP20161703► Subscribe
Poland2922530► Subscribe
Austria547099► Subscribe
Mexico2009000722► Subscribe
Denmark1507502► Subscribe
Russian Federation2009104774► Subscribe
China104042565► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/018United Kingdom► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
/2004Austria► SubscribePRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920
C0054France► SubscribePRODUCT NAME: CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001 20011024
11/024Ireland► SubscribePRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
C/GB06/032United Kingdom► SubscribePRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626
C/GB11/004United Kingdom► SubscribePRODUCT NAME: MANNITOL; REGISTERED: SE 22708 20061020; UK PL 27944/0001-0001 20071218
666Luxembourg► SubscribePRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
C0053Belgium► SubscribePRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072
C0041France► SubscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
2012000051Germany► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
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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:

Cerilliant
AstraZeneca
Covington
Cipla
Moodys
Argus Health
Dow
Accenture
Queensland Health
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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