Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
QuintilesIMS
Covington
Merck
Cerilliant
AstraZeneca
US Army
Chinese Patent Office
Fish and Richardson
US Department of Justice

Generated: August 16, 2017

DrugPatentWatch Database Preview

Fresenius Company Profile

« Back to Dashboard

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

FRESENIUS has two hundred and forty-four 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.

Summary for Applicant: Fresenius

Patents:18
Tradenames:203
Ingredients:149
NDAs:244
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
PYRIDOXINE HYDROCHLORIDE
pyridoxine hydrochloride
INJECTABLE;INJECTION080618-001Approved Prior to Jan 1, 1982APRXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
MORPHINE SULFATE
morphine sulfate
SOLUTION;INTRAMUSCULAR, INTRAVENOUS204223-002Oct 30, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Fresenius Kabi Usa
IOPAMIDOL-300
iopamidol
INJECTABLE;INJECTION074679-002Apr 2, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Medcl
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate
SOLUTION;INTRAPERITONEAL018379-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
HEPARIN SODIUM
heparin sodium
INJECTABLE;INJECTION017029-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Fresenius

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 Medcl
PHOSLO GELCAPS
calcium acetate
CAPSULE;ORAL021160-003Apr 2, 2001► 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Fresenius Drugs

Country Document Number Estimated Expiration
Portugal1605891► Subscribe
Australia2007275606► Subscribe
Austria547099► Subscribe
China1767799► Subscribe
South Africa200506747► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Fresenius Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004012,C0780390Lithuania► SubscribePRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
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
C0009Belgium► SubscribePRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016
C/GB97/013United Kingdom► SubscribePRODUCT NAME: LETROZOLE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: FR 341 474-2 19960724; FR 341 475-9 19960724; UK PL00001/0224 19961118
C0009Belgium► SubscribePRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
McKinsey
Julphar
Boehringer Ingelheim
Harvard Business School
Moodys
QuintilesIMS
AstraZeneca
Teva
Cipla

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot