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Last Updated: April 16, 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 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 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
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

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
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
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-001	Oct 21, 1988	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
West-ward Pharms Int	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	076330-002	Apr 8, 2005	AP	RX	No	Yes	⤷ 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	019667-002	Oct 21, 1988	⤷ Try a Trial	⤷ Try a Trial
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	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	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
Poland	2343982		⤷ Try a Trial
Russian Federation	2552324	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И СООТВЕТСТВУЮЩИЕ СПОСОБЫ ДОСТАВКИ (PHARMACEUTICAL COMPOSITIONS AND RESPECTIVE DELIVERY METHODS)	⤷ Try a Trial
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)	⤷ Try a Trial
Denmark	2343982		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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