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Profile for Tradename: SANDOSTATIN LAR

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Sandostatin Lar is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug.

The generic ingredient in SANDOSTATIN LAR is octreotide acetate. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

Summary for Tradename: SANDOSTATIN LAR

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list7
2013 Sales:$697,961,000

Clinical Trials for: SANDOSTATIN LAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 1998RXNo5,922,682*PED<disabled>Y<disabled>
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 1998RXNo5,688,530*PED<disabled>Y<disabled>
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 1998RXNo5,639,480*PED<disabled><disabled>
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-003Nov 25, 1998RXYes5,639,480*PED<disabled><disabled>
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 1998RXNo5,639,480*PED<disabled><disabled>
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Non-Orange Book Patents for Tradename: SANDOSTATIN LAR

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
5,538,739 Sustained release formulations of water soluble peptides<disabled in preview>
6,353,030 Relating to organic compounds<disabled in preview>
5,876,761 Sustained release formulations of water soluble peptides<disabled in preview>
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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 information. There is no warranty that the information contained herein is error free. 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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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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