SANDOSTATIN Drug Patent Profile
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Which patents cover Sandostatin, and when can generic versions of Sandostatin launch?
Sandostatin is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in SANDOSTATIN is octreotide acetate. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sandostatin
A generic version of SANDOSTATIN was approved as octreotide acetate by WEST-WARD PHARMS INT on April 8th, 2005.
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Questions you can ask:
- What is the 5 year forecast for SANDOSTATIN?
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Summary for SANDOSTATIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 78 |
| Patent Applications: | 3,592 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SANDOSTATIN |
| What excipients (inactive ingredients) are in SANDOSTATIN? | SANDOSTATIN excipients list |
| DailyMed Link: | SANDOSTATIN at DailyMed |
Recent Clinical Trials for SANDOSTATIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Clinica Universidad de Navarra, Universidad de Navarra | Phase 2 |
| ZonMw: The Netherlands Organisation for Health Research and Development | Phase 4 |
| Belgium Health Care Knowledge Centre | Phase 4 |
Pharmacology for SANDOSTATIN
| Drug Class | Somatostatin Analog |
| Mechanism of Action | Somatostatin Receptor Agonists |
Paragraph IV (Patent) Challenges for SANDOSTATIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SANDOSTATIN | Injection | octreotide acetate | 0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative-free) | 019667 | 1 | 2008-01-17 |
US Patents and Regulatory Information for SANDOSTATIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-001 | Oct 21, 1988 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-002 | Nov 25, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-003 | Oct 21, 1988 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-003 | Nov 25, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SANDOSTATIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-001 | Oct 21, 1988 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-005 | Jun 12, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SANDOSTATIN
See the table below for patents covering SANDOSTATIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 3822557 | Arzneimittel, enthaltend Somatostatine | ⤷ Sign Up |
| Australia | 543198 | ⤷ Sign Up | |
| Malaysia | 8500072 | NOVEL POLYPEPTIDES, PROCESSES FOR THEIR PRODUCTION, PHARMACEUTICAL COMPOSITIONS COMPRISING SAID POLYPEPTIDES AND THEIR USE | ⤷ Sign Up |
| Greece | 880100458 | ⤷ Sign Up | |
| Luxembourg | 88344 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SANDOSTATIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0029579 | SPC/GB93/097 | United Kingdom | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 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 verification 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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