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Pegvisomant - Generic Drug Details

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

Pegvisomant is the generic ingredient in one branded drug marketed by Pharmacia And Upjohn and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for Generic Name: pegvisomant

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Clinical Trials: see list14
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Drug Prices:see low prices
DailyMed Link:pegvisomant at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-004Jul 31, 2014RXYesYes5,849,535► SubscribeY ► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-003Mar 25, 2003RXYesYes5,849,535► SubscribeY ► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-001Mar 25, 2003RXYesYes5,849,535► SubscribeY ► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-005Jul 31, 2014RXYesYes5,849,535► SubscribeY ► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-002Mar 25, 2003RXYesYes5,849,535► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pegvisomant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-003Mar 25, 20035,958,879► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-002Mar 25, 20036,583,115► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-001Mar 25, 20035,350,836► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-002Mar 25, 20035,958,879► Subscribe
Pharmacia And Upjohn
SOMAVERT
pegvisomant
INJECTABLE;SUBCUTANEOUS021106-003Mar 25, 20035,350,836► Subscribe
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Non-Orange Book Patents for Generic Ingredient: pegvisomant

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
5,834,250 Method for identifying active domains and amino acid residues in polypeptides and hormone variants► Subscribe
5,955,346 Variants of human prolactin and human placeatal lactogen► Subscribe
8,637,646Growth hormone variants► Subscribe
6,013,478 Method for identifying active domains and amino acid residues in polypeptides and hormone variants► Subscribe
5,854,026 Human growth hormone variant having enhanced affinity for human growth hormone receptor at site 1► 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: pegvisomant

Country Document Number Estimated Expiration
Netherlands300210► Subscribe
Germany69635026► Subscribe
Australia718439► Subscribe
Japan2004121261► Subscribe
European Patent Office0564531► 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: PEGVISOMANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0043France► SubscribePRODUCT NAME: PEGVISOMANT; REGISTRATION NO/DATE: EU/1/02/240/001-003 20021113
0210Netherlands► Subscribe300210, 20160920, EXPIRES: 20171112
C029/2005Ireland► SubscribeSPC029/2005: 20061023, EXPIRES: 20171112
204Luxembourg► Subscribe91204, EXPIRES: 20171113
0851925/01Switzerland► SubscribeFORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
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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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