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Last Updated: May 19, 2024

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 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 twelve 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

International Patents:	63
US Patents:	12
Tradenames:	6
Applicants:	12
NDAs:	24
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	45
Patent Applications:	7,378
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
Albert Einstein College of Medicine	Phase 1
Columbia University	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
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

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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
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	077329-002	Mar 4, 2008		DISCN	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
Sun Pharm Inds	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	077330-001	Mar 4, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	077450-002	Feb 10, 2006	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
West-ward Pharms Int	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	076313-002	Mar 28, 2005	AP	RX	No	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	019667-003	Oct 21, 1988	⤷ 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	021008-003	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 LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	⤷ Try a Trial	⤷ Try a Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	⤷ 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
United Kingdom	2482810	Enhanced delivery of exenatide using a medium chain fatty acid and salt thereof	⤷ Try a Trial
China	102176900	Pharmaceutical compositions and related methods of delivery	⤷ Try a Trial
United Kingdom	0916349		⤷ Try a Trial
Slovenia	2343982		⤷ Try a Trial
Japan	2016074733	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
European Patent Office	3253401	MÉTHODE DE TRAITEMENT DE MALADIES (METHOD OF TREATING DISEASES)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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