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Details for Patent: 5,922,338

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Patent 5,922,338 protects SANDOSTATIN LAR and is included in one NDA.

Protection for SANDOSTATIN LAR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 5,922,338

Title: Polyol esters, their preparation and use in depot forms of pharmacologically active agents
Abstract:This invention provides a polyester of a polyol, said polyol containing at least 3 hydroxyl groups and having a molecular weight of up to 20,000 at least 1 hydroxyl group in said polyol being in the form of an ester, with a poly- or co-poly-lactic acid residue, each having a molecular weight of at least from 5,000. These are useful for parenteral depot formulations.
Inventor(s): Brich; Zdenek (Binningen, CH), Kissel; Thomas (Ehrenkirchen, DE)
Assignee: Novartis AG (Basel, CH)
Application Number:08/471,304
Patent Claim Types:
see list of patent claims
Formulation; Device; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 1998RXNo5,922,338*PED► subscribeY
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 1998RXNo5,922,338*PED► subscribeY
Novartis
SANDOSTATIN LAR
octreotide acetate
INJECTABLE;INJECTION021008-003Nov 25, 1998RXYes5,922,338*PED► subscribeY
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Foreign Priority and PCT Information for Patent: 5,922,338

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Switzerland4671/83Aug 26, 1983

Non-Orange Book Patents for Patent: 5,922,338

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
5,922,682 Polyol esters, their preparation and use in depot forms of pharmacologically active agents► subscribe
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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 Patent: 5,922,338

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria395584► subscribe
AustriaA271384► subscribe
Australia3234884► 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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