Fresenius Kabi Usa Company Profile
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What is the competitive landscape for FRESENIUS KABI USA, and what generic alternatives to FRESENIUS KABI USA drugs are available?
FRESENIUS KABI USA has three hundred and nine 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 sixty-seven supplementary protection certificates in seventeen countries.
Summary for Fresenius Kabi Usa
| International Patents: | 129 |
| US Patents: | 23 |
| Tradenames: | 255 |
| Ingredients: | 189 |
| NDAs: | 309 |
| Patent Litigation for Fresenius Kabi Usa: | See patent lawsuits for Fresenius Kabi Usa |
| PTAB Cases with Fresenius Kabi Usa as petitioner: | See PTAB cases with Fresenius Kabi Usa as petitioner |
| PTAB Cases with Fresenius Kabi Usa as patent owner: | See PTAB cases with Fresenius Kabi Usa as patent owner |
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 | 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 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 017651-008 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Fresenius Kabi Usa | LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 208619-001 | Jan 31, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ 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 Usa
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | DIPRIVAN | propofol | INJECTABLE;INJECTION | 019627-002 | Jun 11, 1996 | 5,714,520*PED | ⤷ Sign Up |
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | 6,589,960 | ⤷ Sign Up |
| Fresenius Kabi Usa | DIPRIVAN | propofol | INJECTABLE;INJECTION | 019627-002 | Jun 11, 1996 | 5,731,356*PED | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for FRESENIUS KABI USA drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ 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 |
| ➤ 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 |
International Patents for Fresenius Kabi Usa Drugs
Supplementary Protection Certificates for Fresenius Kabi Usa Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | CA 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710 |
| 0480717 | 98C0022 | France | ⤷ Sign Up | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
| 2782584 | LUC00245 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701 |
| >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.
