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Last Updated: October 24, 2021

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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 two hundred and eighty-nine approved drugs.

There are twenty-three US patents protecting FRESENIUS KABI drugs. There are three 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 five 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 TOPOTECAN HYDROCHLORIDE topotecan hydrochloride INJECTABLE;INJECTION 091089-001 Nov 29, 2010 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 070966-001 Oct 13, 1987 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 018304-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa IFOSFAMIDE ifosfamide INJECTABLE;INJECTION 076078-002 May 28, 2002 AP RX No Yes ⤷  Free Forever Trial ⤷  Free Forever 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996 4,870,086 ⤷  Free Forever Trial
Fresenius Kabi Usa DILAUDID hydromorphone hydrochloride INJECTABLE;INJECTION 019034-005 Apr 30, 2009 6,589,960 ⤷  Free Forever Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 5,670,524 ⤷  Free Forever Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998 4,695,576 ⤷  Free Forever Trial
>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 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
➤ 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

Supplementary Protection Certificates for Fresenius Kabi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 132014902271575 Italy ⤷  Free Forever Trial PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
2447254 2018015 Norway ⤷  Free Forever Trial PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
0961612 300417 Netherlands ⤷  Free Forever Trial PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
0933372 13/2008 Austria ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Moodys
McKinsey
Medtronic
Baxter

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