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 seven branded drugs marketed by Chiesi, Fresenius Kabi Usa, Gland Pharma Ltd, Heritage, Meitheal, Sagent Pharms Inc, Shuangcheng, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, Novartis, and Sun Pharm, and is included in twenty-six NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Octreotide acetate has seventy-one patent family members in twenty-five countries.

There are nineteen drug master file entries for octreotide acetate. Eleven suppliers are listed for this compound.

Summary for octreotide acetate

International Patents:	71
US Patents:	18
Tradenames:	7
Applicants:	14
NDAs:	26
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	46
Patent Applications:	7,421
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1
Albert Einstein College of Medicine	Phase 1
Columbia University	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
Wockhardt Usa	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	090986-002	May 11, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	204669-002	Dec 27, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	210317-002	Dec 5, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Institutional	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	079198-001	Feb 10, 2011	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Shuangcheng	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	217860-001	May 2, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	021008-001	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-004	Jun 12, 1991	⤷ Sign Up	⤷ Sign Up
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998	⤷ Sign Up	⤷ Sign Up
>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	7252934		⤷ Sign Up
Canada	2737456	PREPARATIONS PHARMACEUTIQUES ET METHODES ASSOCIEES D'ADMINISTRATION (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY)	⤷ Sign Up
Poland	2343982		⤷ Sign Up
Japan	6258368		⤷ Sign Up
Canada	2975599	METHODE DE TRAITEMENT DE MALADIES (METHOD OF TREATING DISEASES)	⤷ Sign Up
Denmark	2343982		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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