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Albumin human - Generic Drug Details
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.
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: | 1,033 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for albumin human |
| DailyMed Link: | albumin human at DailyMed |
Recent Clinical Trials for albumin human
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| BioMarin Pharmaceutical | Phase 4 |
| Dr. Graeme Smith | Early Phase 1 |
| Beijing Friendship Hospital | Phase 2 |
Recent Litigation for albumin human
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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
| Petitioner | Date |
|---|---|
| 2017-11-09 | |
| Cipla Ltd. | 2017-11-09 |
| Actavis LLC | 2017-04-04 |
Pharmacology for albumin human
| Drug Class | Contrast Agent for Ultrasound Imaging |
| Mechanism of Action | Ultrasound Contrast Activity |
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 |
International Patents for albumin human
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2273140 | Start Trial |
| Singapore | 54121 | Start Trial |
| Norway | 313577 | Start Trial |
| Israel | 103120 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9305819 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for albumin human
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 |
| 0961612 | SZ 41/2009 | Austria | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMIN |
| 1853250 | 122014000065 | Germany | Start Trial | PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220 |
| 0961612 | CA 2009 00036 | Denmark | Start Trial | PRODUCT NAME: PACLITAXELALBUMIN |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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