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Octreotide acetate - Generic Drug Details

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

Octreotide acetate is the generic ingredient in five branded drugs marketed by Novartis, West-ward Pharms Int, Sun Pharm Inds, Sagent Pharms, Fresenius Kabi Usa, Teva Pharms Usa, Wockhardt Usa, and Mylan Institutional, and is included in eighteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-seven patent family members in twenty-five countries.

There are eighteen drug master file entries for octreotide acetate. Eight suppliers are listed for this compound.

Summary for Generic Name: octreotide acetate

Tradenames:5
Patents:3
Applicants:8
NDAs:18
Drug Master File Entries: see list18
Suppliers / Packagers: see list8
Bulk Api Vendors: see list70
Clinical Trials: see list515
Patent Applications: see list7,395
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:octreotide acetate at DailyMed

Pharmacology for Ingredient: octreotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wockhardt Usa
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION090986-001May 11, 2011DISCNNoNo► Subscribe► Subscribe
Sagent Pharms
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION091041-002Nov 12, 2013RXNoNo► Subscribe► Subscribe
Mylan Institutional
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
octreotide acetate
INJECTABLE;INJECTION079198-002Feb 10, 2011RXNoNo► Subscribe► Subscribe
Sagent Pharms
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
octreotide acetate
INJECTABLE;INJECTION090834-001Nov 12, 2013RXNoNo► Subscribe► Subscribe
Sun Pharm Inds
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION077373-001Aug 14, 2007RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: octreotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-004Jun 12, 19914,395,403► Subscribe
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 19984,395,403► Subscribe
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-002Oct 21, 19885,753,618*PED► Subscribe
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 19984,395,403► Subscribe
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 19985,922,682*PED► Subscribe
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International Patent Family for Ingredient: octreotide acetate

Country Document Number Estimated Expiration
South Africa8406634► Subscribe
Hong Kong67390► Subscribe
United Kingdom2145422► Subscribe
Netherlands190415► Subscribe
Germany3430852► 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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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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