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Last Updated: October 26, 2021

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Fresenius Kabi Usa Company Profile


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What is the competitive landscape for FRESENIUS KABI USA, and when can generic versions of FRESENIUS KABI USA drugs launch?

FRESENIUS KABI USA has two hundred and eighty-three approved drugs.

There are twenty-three US patents protecting FRESENIUS KABI USA drugs. There are three 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 five 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 OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077450-001 Feb 10, 2006 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa POTASSIUM CHLORIDE 40MEQ potassium chloride INJECTABLE;INJECTION 211087-004 Sep 9, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-002 Oct 30, 2013 RX Yes Yes 9,072,781 ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Fresenius Kabi Usa GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090799-002 Jul 25, 2011 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-003 Oct 30, 2013 RX Yes Yes 9,248,229 ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Fresenius Kabi Usa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078188-001 Feb 27, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial
Fresenius Kabi Usa AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 205604-001 Dec 9, 2015 AP RX No No ⤷  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 Usa

Paragraph IV (Patent) Challenges for FRESENIUS KABI USA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

International Patents for Fresenius Kabi Usa Drugs

Country Patent Number Estimated Expiration
Poland 2626068 ⤷  Free Forever Trial
Denmark 2968729 ⤷  Free Forever Trial
Spain 2343456 ⤷  Free Forever Trial
China 100408013 ⤷  Free Forever Trial
China 100398084 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2005037362 ⤷  Free Forever Trial
Canada 2518617 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Fresenius Kabi Usa Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1870100 122012000047 Germany ⤷  Free Forever Trial PRODUCT NAME: DABIGATRAN ETEXILAT MESILAT = 3-((2-((4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO)-METHYL)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO)-PROPIONSAEURE-ETHYLESTER-METHANSULFONAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
1304992 SPC/GB13/061 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
0694547 2002/028 Ireland ⤷  Free Forever Trial PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
1534313 92923 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
0300652 C300117 Netherlands ⤷  Free Forever Trial PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
1115417 06C0022 France ⤷  Free Forever Trial PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
2785706 122020000046 Germany ⤷  Free Forever Trial PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
>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:

Johnson and Johnson
AstraZeneca
Medtronic
Moodys
Colorcon
McKesson

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.