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Last Updated: September 24, 2023

Octreotide acetate - Generic Drug Details

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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, Gland Pharma Ltd, 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-three NDAs. There are ten 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

International Patents:	62
US Patents:	10
Tradenames:	6
Applicants:	11
NDAs:	23
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	45
Patent Applications:	7,491
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for octreotide acetate
What excipients (inactive ingredients) are in octreotide acetate?	octreotide acetate excipients list
DailyMed Link:	octreotide acetate at DailyMed

See drug prices for octreotide acetate

Recent Clinical Trials for octreotide acetate

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

Sponsor	Phase
Columbia University	Phase 1
Albert Einstein College of Medicine	Phase 1
Debiopharm International SA	Phase 1

See all octreotide acetate clinical trials

Pharmacology for octreotide acetate

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Medical Subject Heading (MeSH) Categories for octreotide acetate

Antineoplastic Agents, Hormonal
Gastrointestinal Agents

Anatomical Therapeutic Chemical (ATC) Classes for octreotide acetate

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	075957-002	Oct 3, 2005	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amryt	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	AP	RX	Yes	Yes	⤷ 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

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

International Patents for octreotide acetate

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Country	Patent Number	Title	Estimated Expiration
Japan	2017088625	医薬組成物および関連する送達方法 (PHARMACEUTICAL COMPOSITION, AND RELATED DELIVERY METHOD)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2016126830		⤷ Try a Trial
Japan	6771528		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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.