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Last Updated: July 13, 2024


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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, 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. 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.

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Drug patent expirations by year for OCTREOTIDE ACETATE

See drug prices for OCTREOTIDE ACETATE

Recent Clinical Trials for OCTREOTIDE ACETATE

Identify potential brand extensions & 505(b)(2) entrants

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 1
Albert Einstein College of MedicinePhase 1
Columbia UniversityPhase 1

See all OCTREOTIDE ACETATE clinical trials

Medical Subject Heading (MeSH) Categories 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
Sagent Pharms Inc OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 090834-003 Nov 12, 2013 AP RX 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

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