Fresenius Kabi Usa Company Profile
✉ Email this page to a colleague
What is the competitive landscape for FRESENIUS KABI USA, and when can generic versions of FRESENIUS KABI USA drugs launch?
FRESENIUS KABI USA has three hundred and one approved drugs.
There are twenty-three US patents protecting FRESENIUS KABI USA drugs. There are two 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-two supplementary protection certificates in seventeen countries.
Summary for Fresenius Kabi Usa
| International Patents: | 129 |
| US Patents: | 23 |
| Tradenames: | 247 |
| Ingredients: | 184 |
| NDAs: | 301 |
| 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 | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-009 | Jan 4, 2011 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065408-001 | Oct 15, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Fresenius Kabi Usa | GENTAMICIN SULFATE | gentamicin sulfate | INJECTABLE;INJECTION | 062366-001 | Aug 4, 1983 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | SENSORCAINE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070553-001 | May 21, 1986 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | SENSORCAINE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070552-001 | May 21, 1986 | 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 Usa
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | 4,695,576 | ⤷ Try a Trial |
| Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-003 | May 1, 1998 | 5,834,489 | ⤷ Try a Trial |
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-002 | Aug 4, 1994 | 6,589,960 | ⤷ Try a Trial |
| Fresenius Kabi Usa | DILAUDID-HP | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-001 | Jan 11, 1984 | 6,589,960 | ⤷ Try a Trial |
| Fresenius Kabi Usa | DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-004 | Apr 30, 2009 | 6,589,960 | ⤷ Try a Trial |
| >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 | 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 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | Injection | 2 mg/mL | ➤ Subscribe | 2011-06-22 |
International Patents for Fresenius Kabi Usa Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2011312264 | ⤷ Try a Trial |
| European Patent Office | 2750664 | ⤷ Try a Trial |
| Japan | 2012524738 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2014140097 | ⤷ Try a Trial |
| European Patent Office | 2191807 | ⤷ Try a 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 |
|---|---|---|---|---|
| 0720599 | CR 2014 00050 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910 |
| 0888289 | SPC/GB09/007 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LACOSAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE FORMS; REGISTERED: UK EU/1/08/470/001 20080829; UK EU/1/08/470/002 20080829; UK EU/1/08/470/003 20080829; UK EU/1/08/470/004 20080829; UK EU/1/08/470/005 20080829; UK EU/1/08/470/006 20080829; UK EU/1/08/470/014 20080829; UK EU/1/08/470/015 20080829; UK EU/1/08/470/016 20080829; UK EU/1/08/470/007 20080829; UK EU/1/08/470/008 20080829; UK EU/1/08/470/009 20080829; UK EU/1/08/470/010 20080829; UK EU/1/08/470/012 20080829; UK EU/1/08/470/013 20080829 |
| 1744764 | 46/2018 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827 |
| 1307486 | C 2012 018 | Romania | ⤷ Try a Trial | PRODUCT NAME: PASIREOTIDA SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTEIACICLO[(4R)-4-(2-AMINOETILCARBAMOILOXI)-L-PROLIL-L-FENILGLICIL-D-TRIPTOFIL-L-LISIL-4-O-BENZIL-L-TIROSIL-L-FENILALANIL-); NATIONAL AUTHORISATION NUMBER: RO EU/1/12/753/001 - RO EU/1/12/753/012; DATE OF NATIONAL AUTHORISATION: 20120424; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/753/001 - EMEA EU/1/12/753/012; DATE OF FIRST AUTHORISATION IN EEA: 20120424 |
| 1304992 | SPC/GB13/061 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
| >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.
