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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Accenture
QuintilesIMS
Baxter
Chinese Patent Office
Healthtrust
Moodys
Medtronic
Merck
Argus Health

Generated: November 19, 2017

DrugPatentWatch Database Preview

Pramlintide acetate - Generic Drug Details

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What are the generic sources for pramlintide acetate and what is the scope of pramlintide acetate freedom to operate?

Pramlintide acetate
is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pramlintide acetate has fifty-nine patent family members in twenty-three countries.

There are two drug master file entries for pramlintide acetate. One supplier is listed for this compound.

Summary for pramlintide acetate

Pharmacology for pramlintide acetate

Drug ClassAmylin Analog
Mechanism of ActionAmylin Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005DISCNNoNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007RXYesNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pramlintide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: pramlintide acetate

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
7,407,934Methods for regulating postprandial blood glucose► Subscribe
5,424,394 Synthetic preparation of amylin and amylin analogues► Subscribe
7,271,238Amylin agonist peptides and uses therefor► Subscribe
6,608,029 Methods for regulating gastrointestinal motility► Subscribe
6,610,824 Amylin agonist peptides and uses therefor► Subscribe
5,998,367 Pramlintide pro H-amylin salts and compositions► Subscribe
5,795,861 Methods for regulating gastrointestinal motility► 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: pramlintide acetate

Country Document Number Estimated Expiration
Brazil9407424► Subscribe
Australia673147► Subscribe
Slovakia31496► Subscribe
Japan3821839► Subscribe
European Patent Office1162207► Subscribe
European Patent Office0717635► Subscribe
Denmark0717635► Subscribe
Hungary9302061► Subscribe
Japan2902115► Subscribe
Russian Federation2177331► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Julphar
Teva
Chubb
Medtronic
Mallinckrodt
Healthtrust
Boehringer Ingelheim
Chinese Patent Office
Federal Trade Commission

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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