OCTREOTIDE ACETATE Drug Patent Profile
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Which patents cover Octreotide Acetate, and what generic alternatives are available?
Octreotide Acetate is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Heritage, Meitheal, Sagent Pharms Inc, Shuangcheng, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, and Mylan Institutional. and is included in twenty-two NDAs.
The generic ingredient in OCTREOTIDE ACETATE is octreotide acetate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Octreotide Acetate
A generic version of OCTREOTIDE ACETATE 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 OCTREOTIDE ACETATE?
- What are the global sales for OCTREOTIDE ACETATE?
- What is Average Wholesale Price for OCTREOTIDE ACETATE?
Summary for OCTREOTIDE ACETATE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 46 |
| Patent Applications: | 3,898 |
| Drug Prices: | Drug price information 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 |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1 |
| Columbia University | Phase 1 |
| Albert Einstein College of Medicine | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Institutional | OCTREOTIDE ACETATE (PRESERVATIVE FREE) | octreotide acetate | INJECTABLE;INJECTION | 079198-002 | Feb 10, 2011 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa Inc | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 210317-003 | Dec 5, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wockhardt Usa | OCTREOTIDE ACETATE PRESERVATIVE FREE | octreotide acetate | INJECTABLE;INJECTION | 090985-001 | 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 |
