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Octreotide acetate - Generic Drug Details
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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 list | 15 |
| Suppliers / Packaging: see list | 9 |
| Therapeutic Class: | Hormonal Agents, Suppressant (Pituitary) |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: octreotide acetate
| Drug Class | Somatostatin Analog |
| Mechanism of Action | Somatostatin Receptor Agonists |
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;INJECTION | 077450-001 | Feb 10, 2006 | RX | No | ||||||||||||||||||||||
Teva Pharms Usa | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 075957-002 | Oct 3, 2005 | RX | No | ||||||||||||||||||||||
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-001 | Nov 25, 1998 | RX | No | 5,922,682*PED | Jan 13, 2017 | Y | |||||||||||||||||||
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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;INJECTION | 021008-002 | Nov 25, 1998 | 5,688,530*PED | <disabled> | ||||||||||||||||||||||
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | 4,395,403 | <disabled> | ||||||||||||||||||||||
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-003 | Nov 25, 1998 | 5,538,739*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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sweden | 503191 | <disabled in preview> | |||||||||||||||||||||||||||
| Hungary | T38265 | <disabled in preview> | |||||||||||||||||||||||||||
| Germany | 3845000 | <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.
Export unavailable in trial.
Subscribe for complete access.
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How are People Using DrugPatentWatch?
To get Information about drug patent expiry for drugs approved in Germany and UK since 1990
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To find Australian patent expiry dates for pharmaceutical products
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To know patent expirations 8-15 years from now and formulation information
— Generic drug importer, Japan
To be informed abut patent protection and patent challenges
— Business development / Licensing / Marketing & sales, Italy
To prepare patent landscapes and give IP clearance for APIs
— Analyst, India
To monitor patent expirations/loss of exclusivity
— Pharmacy director, USA
To identify producers of specific APIs
— Market research, Germany
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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