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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

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
Mylan Institutional
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
octreotide acetate
INJECTABLE;INJECTION079198-003Feb 10, 2011RXNo<disabled><disabled>
Sun Pharm Inds
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION077329-002Mar 4, 2008RXNo<disabled><disabled>
Teva Pharms Usa
OCTREOTIDE ACETATE
octreotide acetate
INJECTABLE;INJECTION075959-001Nov 21, 2005RXNo<disabled><disabled>
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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;INJECTION021008-001Nov 25, 19985,688,530*PED<disabled>
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 19984,395,403<disabled>
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 19985,639,480*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
JapanS6431728<disabled in preview>
Germany3822557<disabled in preview>
Portugal87957<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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