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Last Updated: March 28, 2024

FRESENIUS KABI USA Company Profile


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

FRESENIUS KABI USA has three hundred and one approved drugs.

There are twenty-three US patents protecting FRESENIUS KABI USA drugs. There are two tentative approvals on FRESENIUS KABI USA drugs.

There are one hundred and twenty-nine patent family members on FRESENIUS KABI USA drugs in twenty-five countries and four hundred and sixty supplementary protection certificates in seventeen countries.

Drugs and US Patents for FRESENIUS KABI USA

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 THIOTEPA thiotepa INJECTABLE;INJECTION 075698-001 Sep 20, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 208129-001 Nov 29, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa KETOROLAC TROMETHAMINE ketorolac tromethamine INJECTABLE;INJECTION 075784-002 Jan 11, 2002 AP RX No No ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065245-003 Feb 15, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 075761-001 Oct 15, 2002 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FRESENIUS KABI USA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 4,870,086 ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 5,834,489 ⤷  Try a Trial
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,731,355*PED ⤷  Try a Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-003 Apr 30, 2009 6,589,960 ⤷  Try a Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996 4,870,086 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for FRESENIUS KABI USA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe Oral Solution 5 mg/5mL ➤ Subscribe 2011-02-25
➤ Subscribe Tablets 2 mg, 4 mg, and 8 mg ➤ Subscribe 2013-08-05
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials ➤ Subscribe 2006-11-13
➤ Subscribe Injection 2 mg/mL, 200 mL ➤ Subscribe 2015-09-03
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Injection 2 mg/mL ➤ Subscribe 2011-06-22
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2011-11-04
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 2 mg/mL, 100 mL ➤ Subscribe 2015-01-30

Supplementary Protection Certificates for FRESENIUS KABI USA Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2768484 301016 Netherlands ⤷  Try a Trial PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1532149 92128 Luxembourg ⤷  Try a Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
0933372 13/2008 Austria ⤷  Try a Trial PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
2666774 LUC00167 Luxembourg ⤷  Try a Trial PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
0287150 96C0038 Belgium ⤷  Try a Trial PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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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 verification 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.