You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Octreotide acetate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, and Novartis, and is included in twenty-four NDAs. There are eleven 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
Drug Prices for octreotide acetate

See drug prices for octreotide acetate

Recent Clinical Trials for octreotide acetate

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

SponsorPhase
Columbia UniversityPhase 1
Albert Einstein College of MedicinePhase 1
Debiopharm International SAPhase 1

See all octreotide acetate clinical trials

Pharmacology for octreotide acetate
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
Sun Pharm Inds OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077329-001 Mar 4, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 075957-003 Oct 3, 2005 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
Sagent Pharms Inc OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 091041-001 Nov 12, 2013 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharms OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 203765-001 Sep 7, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt Usa OCTREOTIDE ACETATE PRESERVATIVE FREE octreotide acetate INJECTABLE;INJECTION 090985-001 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

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 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-001 Oct 21, 1988 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-005 Jun 12, 1991 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for octreotide acetate

Country Patent Number Title Estimated Expiration
United Kingdom 201119686 ⤷  Try a Trial
United Kingdom 0916349 ⤷  Try a Trial
Canada 2963659 PREPARATIONS PHARMACEUTIQUES ET METHODES ASSOCIEES D'ADMINISTRATION (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY) ⤷  Try a Trial
Japan 6258368 ⤷  Try a Trial
Spain 2629131 ⤷  Try a Trial
Russian Federation 2019102221 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И СООТВЕТСТВУЮЩИЕ СПОСОБЫ ДОСТАВКИ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.