Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Medtronic
Boehringer Ingelheim
Moodys
Merck

Last Updated: February 3, 2023

Octreotide acetate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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
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
Debiopharm International SAPhase 1
National Institute for Health Research, United KingdomPhase 2
University College, LondonPhase 2

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
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
Heritage Pharms OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 203765-002 Sep 7, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
West-ward Pharms Int OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 076313-001 Mar 28, 2005 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077372-002 Aug 14, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Heritage Pharms OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 204669-003 Dec 27, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-004 Jun 12, 1991 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 075957-003 Oct 3, 2005 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021008-002 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

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

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Express Scripts
Medtronic
AstraZeneca
Johnson and Johnson

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.