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Last Updated: March 28, 2020

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Albumin human - Generic Drug Details

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What are the generic sources for albumin human and what is the scope of freedom to operate?

Albumin human is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Albumin human has forty patent family members in twenty-seven countries.

There are seven drug master file entries for albumin human. One supplier is listed for this compound.

Recent Clinical Trials for albumin human

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
BioMarin PharmaceuticalPhase 4
Dr. Graeme SmithEarly Phase 1
Beijing Friendship HospitalPhase 2

See all albumin human clinical trials

Recent Litigation for albumin human

Identify potential future generic entrants

District Court Litigation
Case NameDate
ABRAXIS BIOSCIENCE, LLC v. SUN PHARMA ADVANCED RESEARCH COMPANY, LTD.2019-08-08
Genentech, Inc. v. Pfizer Inc.2019-04-05
Genentech, Inc. v. Immunex Rhode Island Corp.2019-03-29

See all albumin human litigation

PTAB Litigation
PetitionerDate
2017-11-09
Cipla Ltd.2017-11-09
Actavis LLC2017-04-04

See all albumin human litigation

Pharmacology for albumin human

US Patents and Regulatory Information for albumin human

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare OPTISON albumin human INJECTABLE;INJECTION 020899-001 Dec 31, 1997 RX Yes Yes   Start Trial   Start Trial Y   Start 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 albumin human

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare OPTISON albumin human INJECTABLE;INJECTION 020899-001 Dec 31, 1997   Start Trial   Start Trial
Ge Healthcare OPTISON albumin human INJECTABLE;INJECTION 020899-001 Dec 31, 1997   Start Trial   Start Trial
Ge Healthcare OPTISON albumin human INJECTABLE;INJECTION 020899-001 Dec 31, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for albumin human

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1853250 CA 2014 00034 Denmark   Start Trial PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230
0961612 C00961612/01 Switzerland   Start Trial PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
0961612 09C0050 France   Start Trial PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
1853250 C300673 Netherlands   Start Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250 37/2014 Austria   Start Trial PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
1853250 300673 Netherlands   Start Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
AstraZeneca
Johnson and Johnson
Moodys
Boehringer Ingelheim

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