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Octreotide acetate - Generic Drug Details

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

This ingredient has ninety-four patent family members in thirty countries.

There are fifteen drug master file entries for octreotide acetate. Nine 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 list15
Suppliers / Packaging: see list9
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: octreotide acetate

Clinical Trials for: octreotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION077450-001Feb 10, 2006RXNo
Teva Pharms Usa
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION075957-002Oct 3, 2005RXNo
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 1998RXNo5,922,682*PEDJan 13, 2017Y
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Expired Orange Book Patents for Generic Ingredient: octreotide acetate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 19985,688,530*PED<disabled>
Novartis
SANDOSTATIN
octreotide acetate
INJECTABLE;INJECTION019667-004Jun 12, 19914,395,403<disabled>
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-003Nov 25, 19985,538,739*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: octreotide 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
6,066,616 Somatostatin analogue composition and use in treating breast cancer<disabled in preview>
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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: octreotide acetate

Country Document Number Estimated Expiration
Sweden503191<disabled in preview>
HungaryT38265<disabled in preview>
Germany3845000<disabled in preview>
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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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