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Octreotide acetate - Generic Drug Details
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What are the generic drug sources for octreotide acetate and what is the scope of freedom to operate?
Octreotide acetate
is the generic ingredient in seven branded drugs marketed by Chiasma, Fresenius Kabi Usa, Heritage Pharms Inc, Sagent Pharms Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, Novartis, and Sun Pharm, and is included in twenty-two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Octreotide acetate has fifty-nine patent family members in twenty-four countries.
There are twenty drug master file entries for octreotide acetate. Nine suppliers are listed for this compound.
Summary for octreotide acetate
| International Patents: | 59 |
| US Patents: | 7 |
| Tradenames: | 7 |
| Applicants: | 11 |
| NDAs: | 22 |
| Drug Master File Entries: | 20 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 31 |
| Patent Applications: | 2,936 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for octreotide acetate |
| DailyMed Link: | octreotide acetate at DailyMed |
Recent Clinical Trials for octreotide acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NeuroEndocrine Tumor Research Foundation (NETRF) | Phase 1 |
| Roswell Park Cancer Institute | Phase 1 |
| Ono Pharmaceutical Co. Ltd | Phase 1 |
Pharmacology for octreotide acetate
| Drug Class | Somatostatin Analog |
| Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for octreotide acetate
Paragraph IV (Patent) Challenges for OCTREOTIDE ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SANDOSTATIN | INJECTABLE;INJECTION | octreotide acetate | 019667 | 2008-01-17 |
US Patents and Regulatory Information for octreotide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Institutional | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | octreotide acetate | INJECTABLE;INJECTION | 079198-002 | Feb 10, 2011 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Wockhardt Usa | OCTREOTIDE ACETATE PRESERVATIVE FREE | octreotide acetate | INJECTABLE;INJECTION | 090985-001 | May 11, 2011 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Heritage Pharms Inc | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 203765-001 | Sep 7, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Inds | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 077329-003 | Mar 4, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Inds | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 077372-001 | Aug 14, 2007 | DISCN | No | No | Start Trial | Start Trial | Start 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 octreotide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-003 | Oct 21, 1988 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-003 | Nov 25, 1998 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-003 | Nov 25, 1998 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-002 | Nov 25, 1998 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for octreotide acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2011115060 | Start Trial |
| Spain | 2629131 | Start Trial |
| Hong Kong | 1243597 | Start Trial |
| South Korea | 20200003923 | Start Trial |
| Israel | 245172 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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