OCTREOTIDE ACETATE - Generic Drug Details
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What are the generic sources for octreotide acetate and what is the scope of patent protection?
Octreotide acetate
is the generic ingredient in six branded drugs marketed by Chiesi, Fresenius Kabi Usa, Gland Pharma Ltd, Heritage Pharms, Meitheal, Sagent Pharms Inc, Shuangcheng, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, and Novartis, and is included in twenty-five NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Octreotide acetate has sixty-three patent family members in twenty-five countries.
There are nineteen drug master file entries for octreotide acetate. Ten suppliers are listed for this compound.
Summary for OCTREOTIDE ACETATE
International Patents: | 63 |
US Patents: | 13 |
Tradenames: | 6 |
Applicants: | 13 |
NDAs: | 25 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 53 |
Clinical Trials: | 46 |
Patent Applications: | 7,433 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for OCTREOTIDE ACETATE |
What excipients (inactive ingredients) are in OCTREOTIDE ACETATE? | OCTREOTIDE ACETATE excipients list |
DailyMed Link: | OCTREOTIDE ACETATE at DailyMed |
Recent Clinical Trials for OCTREOTIDE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1 |
Albert Einstein College of Medicine | Phase 1 |
Columbia University | Phase 1 |
Pharmacology for OCTREOTIDE ACETATE
Drug Class | Somatostatin Analog |
Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for OCTREOTIDE ACETATE
Anatomical Therapeutic Chemical (ATC) Classes for OCTREOTIDE ACETATE
Paragraph IV (Patent) Challenges for OCTREOTIDE ACETATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MYCAPSSA | Delayed-release Capsules | octreotide acetate | 20 mg | 208232 | 1 | 2023-12-29 |
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 OCTREOTIDE ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | octreotide acetate | INJECTABLE;INJECTION | 077457-002 | Feb 10, 2006 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chiesi | MYCAPSSA | octreotide acetate | CAPSULE, DELAYED RELEASE;ORAL | 208232-001 | Jun 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Shuangcheng | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 217860-001 | May 2, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sagent Pharms Inc | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 091041-002 | Nov 12, 2013 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
West-ward Pharms Int | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | octreotide acetate | INJECTABLE;INJECTION | 076313-001 | Mar 28, 2005 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Wockhardt Usa | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 090986-001 | May 11, 2011 | DISCN | No | No | ⤷ 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 OCTREOTIDE ACETATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-001 | Nov 25, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-002 | Nov 25, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-003 | Nov 25, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-002 | Nov 25, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OCTREOTIDE ACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2021050240 | 医薬組成物および関連する送達方法 (PHARMACEUTICAL COMPOSITION, AND RELATED DELIVERY METHOD) | ⤷ Sign Up |
South Korea | 101814186 | ⤷ Sign Up | |
Hong Kong | 1143072 | ENHANCED BIOAVAILABILITY OF OCTREOTIDE VIS THE GI TRACT USING A SUSPENSION IN A HYDROPHOBIC MEDIUM | ⤷ Sign Up |
New Zealand | 591810 | PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY THE COMPOSITION COMPRISES A MEDIUM CHAIN FATTY ACID | ⤷ Sign Up |
Israel | 276157 | תכשירי רוקחות ושיטות להעברתם הקשורות להן (Pharmaceutical compositions and related methods of delivery) | ⤷ Sign Up |
United Kingdom | 0916349 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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