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Albumin human - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for albumin human?

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 thirty-nine patent family members in twenty-seven countries.

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

Summary for Generic Name: albumin human

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packagers: see list1
Clinical Trials: see list3,297
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:albumin human at DailyMed

Pharmacology for Ingredient: albumin human

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 1997RXYesYes6,723,303► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: albumin human

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 19975,529,766► Subscribe
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 19975,558,094► Subscribe
Ge Healthcare
OPTISON
albumin human
INJECTABLE;INJECTION020899-001Dec 31, 19975,573,751► Subscribe
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Non-Orange Book Patents for Generic Ingredient: albumin human

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,393,524 Methods for selecting and using gases as ultrasound contrast media► Subscribe
6,620,404 Gaseous ultrasound contrast media and method for selecting gases for use as ultrasound contrast media► Subscribe
5,573,751 Persistent gaseous bubbles as ultrasound contrast media► Subscribe
6,156,292 Gaseous ultrasound contrast media and method for selecting gases for use as ultrasound contrast media► Subscribe
6,875,420 Method of ultrasound imaging► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: albumin human

Country Document Number Estimated Expiration
Greece3033908► Subscribe
Spain2145011► Subscribe
South Africa9207114► Subscribe
Finland119466► Subscribe
Denmark0605477► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ALBUMIN HUMAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8 50005-2014Slovakia► SubscribePRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
2014 00034Denmark► SubscribePRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
00673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
/2014Austria► SubscribePRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
0673Netherlands► SubscribePRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
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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 verifification 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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