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 Pharms, Meitheal, Sagent Pharms Inc, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, and Mylan Institutional. and is included in twenty-one NDAs.
The generic ingredient in OCTREOTIDE ACETATE 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 Octreotide Acetate
A generic version of OCTREOTIDE ACETATE was approved as octreotide acetate by WEST-WARD PHARMS INT on April 8th, 2005.
Summary for OCTREOTIDE ACETATE
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 45 |
| Patent Applications: | 4,082 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Albert Einstein College of Medicine | Phase 1 |
| Columbia University | Phase 1 |
| Debiopharm International SA | 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 | 079198-003 | Feb 10, 2011 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| West-ward Pharms Int | OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 076330-001 | Apr 8, 2005 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Wockhardt Usa | OCTREOTIDE ACETATE PRESERVATIVE FREE | octreotide acetate | INJECTABLE;INJECTION | 090985-002 | May 11, 2011 | DISCN | No | No | ⤷ 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 |
