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Last Updated: July 16, 2024

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 three hundred and nine approved drugs.

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

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

Drugs and US Patents for Fresenius Kabi

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 DIAZEPAM diazepam INJECTABLE;INJECTION 214745-001 Nov 10, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa BENZTROPINE MESYLATE benztropine mesylate INJECTABLE;INJECTION 090233-001 Jul 28, 2009 AP RX No No ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091376-001 Nov 29, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa ROMIDEPSIN romidepsin POWDER;INTRAVENOUS 206254-001 Oct 12, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa BORTEZOMIB bortezomib POWDER;INTRAVENOUS 205004-001 Nov 6, 2017 DISCN No No 8,962,572 ⤷  Sign Up Y ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa DIPRIVAN propofol INJECTABLE;INJECTION 019627-002 Jun 11, 1996 5,731,355*PED ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 8,162,915 ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 4,870,086 ⤷  Sign Up
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 6,589,960 ⤷  Sign Up
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998 5,670,524 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for FRESENIUS KABI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

Supplementary Protection Certificates for Fresenius Kabi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 10C0038 France ⤷  Sign Up PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0206283 C980016 Netherlands ⤷  Sign Up PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
1425001 SPC/GB14/034 United Kingdom ⤷  Sign Up PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
3347352 2290051-8 Sweden ⤷  Sign Up PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
1744764 2018/042 Ireland ⤷  Sign Up PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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