Fresenius Company Profile
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What is the competitive landscape for FRESENIUS, and what generic alternatives to FRESENIUS drugs are available?
FRESENIUS has three hundred and twenty-three approved drugs.
There are twenty-six US patents protecting FRESENIUS drugs. There are two tentative approvals on FRESENIUS drugs.
There are one hundred and fifty patent family members on FRESENIUS drugs in twenty-seven countries and four hundred and sixty-two supplementary protection certificates in seventeen countries.
Summary for Fresenius
| International Patents: | 150 |
| US Patents: | 26 |
| Tradenames: | 276 |
| Ingredients: | 190 |
| NDAs: | 323 |
| Patent Litigation for Fresenius: | See patent lawsuits for Fresenius |
| PTAB Cases with Fresenius as petitioner: | See PTAB cases with Fresenius as petitioner |
| PTAB Cases with Fresenius as patent owner: | See PTAB cases with Fresenius as patent owner |
Drugs and US Patents for Fresenius
Expired US Patents for Fresenius
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fresenius Medcl | PHOSLO | calcium acetate | CAPSULE;ORAL | 021160-002 | Apr 2, 2001 | 4,870,105 | ⤷ Try a Trial |
| 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 drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ 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 | Capsules | EQ 169 mg calcium | ➤ Subscribe | 2005-05-31 |
| ➤ 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 | Oral Solution | 667 mg/5 mL | ➤ Subscribe | 2013-12-05 |
International Patents for Fresenius Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2009000722 | ⤷ Try a Trial |
| Australia | 2010238854 | ⤷ Try a Trial |
| Japan | 2012510330 | ⤷ Try a Trial |
| Russian Federation | 2009104774 | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2008011126 | ⤷ Try a Trial |
| Hong Kong | 1202815 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Fresenius 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 |
| 2158901 | 122018000042 | Germany | ⤷ Try a Trial | PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921 |
| >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.
