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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Fish and Richardson
Chubb
Fuji
US Army
Colorcon
Covington
Healthtrust
Medtronic

Generated: February 22, 2018

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 fifty-four approved drugs.

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

There are one hundred and thirty-four patent family members on FRESENIUS drugs in twenty-seven countries and two hundred and thirty-five supplementary protection certificates in twelve countries.

Summary for Fresenius
International Patents:134
US Patents:19
Tradenames:211
Ingredients:156
NDAs:254

Drugs and US Patents for Fresenius

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 MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 208878-001 Mar 28, 2017 RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Oncol LETROZOLE letrozole TABLET;ORAL 090491-001 Jun 3, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 088400-001 Jan 16, 1984 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa VINBLASTINE SULFATE vinblastine sulfate INJECTABLE;INJECTION 089515-001 Apr 29, 1987 RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018379-003 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa POLOCAINE-MPF mepivacaine hydrochloride INJECTABLE;INJECTION 089408-001 Dec 1, 1986 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 076145-001 Jul 29, 2004 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Medcl DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018883-002 Nov 30, 1984 AT RX No No ➤ Try a Free Trial ➤ Try a Free Trial
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) 200656-001 Aug 25, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089003-001 May 31, 1985 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Fresenius

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 4,870,086 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 4,870,086 ➤ Try a Free Trial
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,714,520*PED ➤ Try a Free Trial
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,908,869*PED ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 4,695,576 ➤ Try a Free Trial
Fresenius Medcl PHOSLO calcium acetate CAPSULE;ORAL 021160-002 Apr 2, 2001 4,870,105 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 5,670,524 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 4,695,576 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 4,695,576 ➤ Try a Free Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 5,670,524 ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for FRESENIUS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 2 mg/mL, 200 mL ➤ Subscribe 9/3/2015
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 5/1/2015
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 4/14/2015
➤ Subscribe Injection 2 mg/mL, 100 mL ➤ Subscribe 1/30/2015
➤ Subscribe Oral Solution 667 mg/5 mL ➤ Subscribe 12/5/2013
➤ Subscribe Tablets 2 mg, 4 mg, and 8 mg ➤ Subscribe 8/5/2013
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 12/16/2011
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 11/4/2011
➤ Subscribe Injection 2 mg/mL ➤ Subscribe 6/22/2011
➤ Subscribe Oral Solution 5 mg/5mL ➤ Subscribe 2/25/2011
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 9/24/2007
➤ Subscribe Injection 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials ➤ Subscribe 11/13/2006
➤ Subscribe Capsules EQ 169 mg calcium ➤ Subscribe 5/31/2005

Non-Orange Book US 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 ➤ Try a Free Trial
9,545,473 Packaging system for oxygen-sensitive drugs ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for Fresenius Drugs

Supplementary Protection Certificates for Fresenius Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1999 Austria ➤ Try a Free Trial PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204
2010 00036 Denmark ➤ Try a Free Trial PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
01C/030 Belgium ➤ Try a Free Trial PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
C0055 France ➤ Try a Free Trial PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811
00482 Netherlands ➤ Try a Free Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
C0002 France ➤ Try a Free Trial PRODUCT NAME: MANNITOL; NAT. REGISTRATION NO/DATE: NL 34557 20080819; FIRST REGISTRATION: SE - 22708 20061020
1997 Austria ➤ Try a Free Trial PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016
13/044 Ireland ➤ Try a Free Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Teva
Boehringer Ingelheim
Colorcon
Moodys
Farmers Insurance
QuintilesIMS
Julphar
Fuji

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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