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.
Summary for SANDOSTATIN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 76 |
Patent Applications: | 5,094 |
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 |
---|---|
ZonMw: The Netherlands Organisation for Health Research and Development | Phase 4 |
Belgium Health Care Knowledge Centre | Phase 4 |
University Hospital, Antwerp | Phase 4 |
Pharmacology for SANDOSTATIN
Drug Class | Somatostatin Analog |
Mechanism of Action | Somatostatin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SANDOSTATIN
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-002 | Nov 25, 1998 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-003 | Oct 21, 1988 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-003 | Nov 25, 1998 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | 019667-003 | Oct 21, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-001 | Oct 21, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Denmark | 174476 | ⤷ Try a Trial | |
Spain | 8305701 | ⤷ Try a Trial | |
Singapore | 3592 | ⤷ Try a Trial | |
Germany | 3845000 | Anwendung von Octreotid zur Behandlung von Brustkrebs (Compsn. contg. somatostatin analogues for treating breast cancer) | ⤷ Try a Trial |
Hong Kong | 30686 | POLYPEPTIDES,PROCESSES FOR THEIR PRODUCTION,PHARMACEUTICAL COMPOSITIONS COMPRISING SAID POLYPEPTIDES AND THEIR USE | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |