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Last Updated: December 7, 2019

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ALBUMIN HUMAN - Generic Drug Details

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What are the generic drug 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.

Summary for ALBUMIN HUMAN
International Patents:40
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 7
Suppliers / Packagers: 1
Clinical Trials: 994
Formulation / Manufacturing:see details
DailyMed Link:ALBUMIN HUMAN at DailyMed
Recent Clinical Trials for ALBUMIN HUMAN

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

SponsorPhase
Yan'an Affiliated Hospital of Kunming Medical UniversityEarly Phase 1
Karolinska University HospitalPhase 3
University of California, Los AngelesEarly Phase 1

See all ALBUMIN HUMAN clinical trials

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 2014C/037 Belgium   Start Trial PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
1853250 238 50005-2014 Slovakia   Start Trial PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
1853250 122014000065 Germany   Start Trial PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1853250 300673 Netherlands   Start Trial PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612 CA 2009 00036 Denmark   Start Trial PRODUCT NAME: PACLITAXELALBUMIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Boehringer Ingelheim
Baxter
McKinsey
Colorcon

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