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-three supplementary protection certificates in seventeen countries.
Summary for Fresenius Kabi
| International Patents: | 129 |
| US Patents: | 23 |
| Tradenames: | 253 |
| Ingredients: | 187 |
| NDAs: | 309 |
| Patent Litigation for Fresenius Kabi: | See patent lawsuits for Fresenius Kabi |
| PTAB Cases with Fresenius Kabi as petitioner: | See PTAB cases with Fresenius Kabi as petitioner |
| PTAB Cases with Fresenius Kabi as patent owner: | See PTAB cases with Fresenius Kabi as patent owner |
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 Oncol | MITOXANTRONE HYDROCHLORIDE | mitoxantrone hydrochloride | INJECTABLE;INJECTION | 078606-001 | May 14, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Fresenius Kabi Usa | OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 090030-003 | Jan 31, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Fresenius Kabi Usa | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 211269-003 | Apr 5, 2024 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 213523-001 | Mar 9, 2021 | AP | RX | No | No | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | 6,589,960 | ⤷ Try a Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | 8,118,802 | ⤷ Try a Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-006 | Sep 24, 1996 | 8,118,802 | ⤷ Try a Trial |
| Fresenius Kabi Usa | DIPRIVAN | propofol | INJECTABLE;INJECTION | 019627-002 | Jun 11, 1996 | 5,908,869*PED | ⤷ Try a 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 | 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 Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3424547 | ⤷ Try a Trial |
| Spain | 2343456 | ⤷ Try a Trial |
| Slovenia | 1605891 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2014081443 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Fresenius Kabi Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1273292 | C01273292/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009 |
| 2701720 | 3/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818 |
| 1304992 | 2013C/060 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 1183240 | C 2010 011 | Romania | ⤷ Try a Trial | PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...] |
| >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.
