FRESENIUS KABI USA Company Profile
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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 three 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-six supplementary protection certificates in seventeen countries.
Summary for FRESENIUS KABI USA
International Patents: | 129 |
US Patents: | 23 |
Tradenames: | 253 |
Ingredients: | 187 |
NDAs: | 303 |
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 | DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-005 | Apr 30, 2009 | DISCN | Yes | No | 9,731,082 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Fresenius Kabi Usa | CEFAZOLIN SODIUM | cefazolin sodium | INJECTABLE;INJECTION | 064169-001 | Aug 14, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Fresenius Kabi Usa | VINCRISTINE SULFATE | vincristine sulfate | INJECTABLE;INJECTION | 076296-001 | Dec 20, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-005 | Sep 24, 1996 | AP | RX | Yes | 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 | 5,731,355*PED | ⤷ Sign Up |
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-001 | May 1, 1998 | 8,162,915 | ⤷ Sign Up |
Fresenius Kabi Usa | NAROPIN | ropivacaine hydrochloride | SOLUTION;INJECTION | 020533-004 | Sep 24, 1996 | 4,870,086 | ⤷ Sign Up |
Fresenius Kabi Usa | DILAUDID | hydromorphone hydrochloride | INJECTABLE;INJECTION | 019034-005 | Apr 30, 2009 | 6,589,960 | ⤷ 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 | 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 |
➤ Subscribe | Injection | 2 mg/mL, 200 mL | ➤ Subscribe | 2015-09-03 |
International Patents for FRESENIUS KABI USA Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 2421522 | ⤷ Sign Up |
European Patent Office | 2968132 | ⤷ Sign Up |
Spain | 2343456 | ⤷ Sign Up |
Hong Kong | 1166957 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FRESENIUS KABI USA Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0809498 | 10C0038 | France | ⤷ Sign Up | PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026 |
0206283 | C980016 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606 |
1425001 | SPC/GB14/034 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114 |
3347352 | 2290051-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.