Fresenius Kabi Company Profile
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What is the competitive landscape for FRESENIUS KABI
FRESENIUS KABI has three hundred and thirty-four approved drugs.
There are twenty-four US patents protecting FRESENIUS KABI drugs. There are two tentative approvals on FRESENIUS KABI drugs.
Summary for Fresenius Kabi
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 | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | AP | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Fresenius Kabi Usa | LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 088586-002 | Approved Prior to Jan 1, 1982 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Fresenius Kabi Usa | CEFUROXIME SODIUM | cefuroxime sodium | INJECTABLE;INJECTION | 065001-002 | May 30, 2001 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| Fresenius Kabi Usa | HALOPERIDOL | haloperidol lactate | INJECTABLE;INJECTION | 075689-001 | Mar 9, 2001 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Fresenius Kabi Usa | MORPHINE SULFATE | morphine sulfate | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 204223-003 | Oct 30, 2013 | DISCN | Yes | No | 9,192,608 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Fresenius Kabi Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 065122-002 | Nov 29, 2002 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start 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 | 4,695,576 | ⤷ Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | 7,828,787 | ⤷ Start Trial |
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589-001 | Jul 27, 2018 | 10,350,186 | ⤷ Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | 5,834,489 | ⤷ Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | 4,695,576 | ⤷ Start Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | 4,870,086 | ⤷ Start 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 | 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 |
| ➤ 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 |
International Patents for Fresenius Kabi Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2011312264 | ⤷ Start Trial |
| Spain | 2405262 | ⤷ Start Trial |
| Japan | 6215970 | ⤷ Start Trial |
| Denmark | 1673135 | ⤷ Start Trial |
| Norway | 20062091 | ⤷ Start Trial |
| European Patent Office | 2243477 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Fresenius Kabi Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2701720 | SPC/GB23/004 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTERED: UK EU/1/22/1669/001(NI) 20220818; UK MORE ON HISTORY TAB 20220818 |
| 0984957 | 300483 | Netherlands | ⤷ Start Trial | PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105 |
| 0484186 | CR 2011 00031 | Denmark | ⤷ Start Trial | PRODUCT NAME: 4-AMINOPYRIDIN ELLER ET SALT DERAF, HERUNDER FAMPRIDIN; REG. NO/DATE: EU/1/11/699/001-002 20110720 |
| 0321122 | SPC/GB96/057 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112 |
| 3752510 | 2025C/547 | Belgium | ⤷ Start Trial | PRODUCT NAME: VANZACAFTOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR EEN CALCIUMZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1943 20250701 |
| 2768484 | 301016 | Netherlands | ⤷ Start Trial | PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: NOT AVAILABLE |
| >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.
Here is a list of applicants with similar names.
