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Last Updated: May 20, 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
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
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
Sagent Pharms Inc	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	091041-002	Nov 12, 2013	AP	RX	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
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Teva Pharms Usa Inc	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	210317-001	Dec 5, 2023	AB	RX	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
>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 LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	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	019667-004	Jun 12, 1991	⤷ 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	021008-003	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 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	2019048871	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
Japan	2019048872	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
Israel	276157	תכשירי רוקחות ושיטות להעברתם הקשורות להן (Pharmaceutical compositions and related methods of delivery)	⤷ Try a Trial
Australia	2022201269	Method of treating diseases	⤷ Try a Trial
Japan	2021050240	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
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
South Korea	20160142408	약제학적 조성물 및 연관된 투여방법 (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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