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Details for Generic Name: technetium tc-99m apcitide

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Technetium tc-99m apcitide is the generic ingredient in one branded drug marketed by Cis Bio Intl Sa and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and forty-five patent family members in twenty-five countries.

There are four drug master file entries for technetium tc-99m apcitide.

Summary for Generic Name: technetium tc-99m apcitide

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list4

Clinical Trials for: technetium tc-99m apcitide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cis Bio Intl Sa
ACUTECT
technetium tc-99m apcitide
INJECTABLE;INJECTION020887-001Sep 14, 1998DISCNNo5,645,815<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: technetium tc-99m apcitide

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
5,811,394 Technetium-99m labeled polypeptides for imaging<disabled in preview>
5,932,189 Cyclic peptide somatostatin analogs<disabled in preview>
5,681,541 Technetium-99m labeled radiopharmaceutical kit for imaging<disabled in preview>
5,993,775 Radioactively labeled peptides comprising a single thiol moiety<disabled in preview>
5,843,401 Radioactively labeled somatostatin-derived peptides for imaging and therapeutic uses<disabled in preview>
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International Patent Family for Ingredient: technetium tc-99m apcitide

Country Document Number Publication Date
JapanH09512555Dec 16, 1997
Spain2204954May 01, 2004
European Patent Office0614379Feb 13, 2002
Austria329624Jul 15, 2006
Norway974494Sep 29, 1997
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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.

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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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