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 six branded drugs marketed by Amryt, Fresenius Kabi Usa, Heritage Pharms, Sagent Pharms Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, and Novartis, and is included in twenty-one NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Octreotide acetate has sixty-two patent family members in twenty-five countries.
There are nineteen drug master file entries for octreotide acetate. Nine suppliers are listed for this compound.
Summary for octreotide acetate
International Patents: | 62 |
US Patents: | 9 |
Tradenames: | 6 |
Applicants: | 10 |
NDAs: | 21 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 44 |
Patent Applications: | 6,723 |
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 |
---|---|
Debiopharm International SA | Phase 1 |
National Institute for Health Research, United Kingdom | Phase 2 |
University College, London | Phase 2 |
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 | 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 octreotide acetate
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 | 021008-002 | Nov 25, 1998 | See Plans and Pricing | See Plans and Pricing |
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-001 | Nov 25, 1998 | See Plans and Pricing | See Plans and Pricing |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | See Plans and Pricing | See Plans and Pricing |
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-003 | Nov 25, 1998 | See Plans and Pricing | See Plans and Pricing |
Novartis | SANDOSTATIN LAR | octreotide acetate | INJECTABLE;INJECTION | 021008-002 | Nov 25, 1998 | See Plans and Pricing | See Plans and Pricing |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-001 | Oct 21, 1988 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for octreotide acetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 591810 | PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY THE COMPOSITION COMPRISES A MEDIUM CHAIN FATTY ACID | See Plans and Pricing |
Russian Federation | 2552324 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И СООТВЕТСТВУЮЩИЕ СПОСОБЫ ДОСТАВКИ (PHARMACEUTICAL COMPOSITIONS AND RESPECTIVE DELIVERY METHODS) | See Plans and Pricing |
Brazil | PI0918652 | Composições farmacêuticas e métodos de libração relacionadas. | See Plans and Pricing |
South Korea | 101683314 | See Plans and Pricing | |
China | 106974888 | 药物组合物和相关的给药方法 (Pharmaceutical compositions and related methods of delivery) | See Plans and Pricing |
Hong Kong | 1243597 | 包含多肽的藥物組合物和相關的遞送方法 (PHARMACEUTICAL COMPOSITIONS COMPRISING POLYPEPTIDES AND RELATED METHODS OF DELIVERY) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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