OCTREOTIDE ACETATE - Generic Drug Details

What are the generic sources for octreotide acetate and what is the scope of patent protection?

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:	7,387
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
Columbia University	Phase 1
Albert Einstein College of Medicine	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

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
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991		DISCN	Yes	No
Wockhardt Usa	OCTREOTIDE ACETATE PRESERVATIVE FREE	octreotide acetate	INJECTABLE;INJECTION	090985-002	May 11, 2011		DISCN	No	No
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-004	Jun 12, 1991		DISCN	Yes	No
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes			Y
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes
Gland Pharma Ltd	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	216807-002	Jun 13, 2023	AP	RX	No	No

Expired US Patents for OCTREOTIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998

International Patents for OCTREOTIDE ACETATE

Country	Patent Number	Title	Estimated Expiration
Israel	211799	תכשירי רוקחות ושיטות להעברתם הקשורות להן (Pharmaceutical compositions and related methods of delivery)
South Africa	202301198	METHOD OF TREATING DISEASES
South Korea	101683314
China	102176900
Mexico	2011002836	COMPOSICIONES FARMACEÚTICAS Y MÉTODOS DE ADMINISTRACIÓN RELACIONADOS. (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY.)
Canada	3080587	UTILISATION DE COMPOSITIONS ORALES D'OCTREOTRIDE (USE OF ORAL OCTREOTRIDE COMPOSITIONS)
European Patent Office	3210474	COMPOSITIONS PHARMACEUTIQUES COMPRENANT DES POLYPEPTIDES ET PROCÉDÉS ASSOCIÉS D'ADMINISTRATION (PHARMACEUTICAL COMPOSITIONS COMPRISING POLYPEPTIDES AND RELATED METHODS OF DELIVERY)

OCTREOTIDE ACETATE Market Analysis and Financial Projection Experimental

Octreotide Acetate Market Dynamics and Financial Trajectory

Market Overview

The octreotide acetate market is experiencing significant growth, driven by the increasing prevalence of endocrine and neuroendocrine disorders. Octreotide, a synthetic analog of the hormone somatostatin, is crucial in managing conditions such as acromegaly, carcinoid syndrome, and other neuroendocrine tumors (NETs)[3][4].

Market Size and Forecast

As of 2023, the global octreotide acetate market was valued at approximately USD 3.08 billion and is projected to reach USD 3.81 billion by 2031, growing at a compound annual growth rate (CAGR) of 3.1% during the forecast period from 2024 to 2031[1].

Another forecast indicates that the global octreotide market was valued at USD 2.1 billion in 2023 and is anticipated to reach USD 3.4 billion by 2033, growing at a CAGR of 4.9% from 2024 to 2033[3].

Geographic Segmentation

The octreotide acetate market is segmented geographically into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

• North America: This region holds a significant share of the market due to advanced healthcare systems, high prevalence of neuroendocrine tumors, and robust research funding. The United States and Canada are key contributors, with strong adoption of octreotide in treatments and clinical settings[1][4].
• Europe: The market in Europe is driven by high incidences of endocrine disorders and supportive governmental health policies. Major countries such as the United Kingdom, Germany, and France demonstrate increasing investments in healthcare[1].
• Asia-Pacific: This region is the fastest-growing market, driven by increasing healthcare expenditures, rising chronic disease rates, and an expanding patient pool. Countries like China, India, and Japan are emerging as significant markets due to their large populations and improving healthcare infrastructure[1][3][4].
• Middle East and Africa: Market growth in this region faces challenges such as limited healthcare access and varying regulatory environments. However, there is an increasing focus on improving healthcare services that could boost the segment[1].
• Latin America: This region represents a smaller market share but shows potential growth driven by increasing healthcare reforms and awareness about treatments for rare diseases[1].

Key Players

The major players in the octreotide acetate market include:

• Novartis AG
• Sun Pharmaceutical Industries Ltd
• China National Pharmaceutical Group Corporation
• Sihuan Pharmaceutical Holdings Group Ltd
• Shanghai Soho-Yiming Pharmaceuticals Co., Ltd
• JB Pharma
• Samarth Life Sciences Pvt. Ltd[1].

Market Dynamics

Drivers of Market Growth

• Rising Prevalence of Endocrine Disorders: The increasing global burden of diseases like acromegaly and carcinoid tumors is fueling demand for octreotide due to its efficacy in symptom management[3][4].
• Innovations in Drug Formulations: The development and approval of novel octreotide formulations, including long-acting and extended-release products, offer more effective and convenient treatment options, improving patient adherence and outcomes[3][4].
• Expanding Healthcare Infrastructure: Emerging economies, particularly in the Asia-Pacific region, are enhancing their healthcare capabilities, increasing access to specialty drugs like octreotide[3][4].

Market Restraints

• High Costs: The high costs associated with octreotide therapies impact affordability, especially in low-income regions, creating barriers to access for some patients[4].
• Regulatory Challenges: Stringent clinical trial requirements can delay the entry of new formulations, impacting growth. Potential side effects, such as gastrointestinal disturbances and metabolic alterations, can also deter usage[4].

Cost-Effectiveness

Octreotide acetate has been shown to be cost-effective in treating certain conditions. For instance, using octreotide in treating carcinoid tumors and VIPoma was associated with doubled survival time and was found to be cost-effective, with costs of $752 per additional year of life for carcinoid tumors[2].

Future Outlook

The global octreotide acetate market is expected to continue its growth trajectory, driven by the rising prevalence of acromegaly and neuroendocrine tumors, the increasing demand for effective and safe treatments, and the ongoing advancements in drug development and delivery technologies. The Asia-Pacific region is anticipated to be the fastest-growing market, with countries like China and India leading the way[3][4].

Technological Advancements

Technological innovations in drug delivery systems, such as subcutaneous and sustained-release formulations, implantable devices, and transdermal patches, are enhancing patient convenience and adherence to treatment. These advancements are expected to further drive market growth and improve patient outcomes[3][4].

Market Opportunities

• Expanding Therapeutic Applications: Research into octreotide’s efficacy in treating additional conditions, such as certain gastrointestinal and liver disorders, presents new market avenues[4].
• Emerging Economies: Increasing healthcare spending and infrastructure investments in emerging economies are likely to boost demand for octreotide[4].
• Digital Health Integration: Pharmaceutical companies are exploring partnerships with digital health providers to integrate monitoring technologies that optimize dosage and improve patient outcomes, underscoring the market's potential for growth[4].

Key Takeaways

• The octreotide acetate market is projected to grow significantly, driven by the increasing prevalence of endocrine and neuroendocrine disorders.
• North America and Europe are currently leading the market, but the Asia-Pacific region is expected to be the fastest-growing segment.
• Innovations in drug formulations and expanding healthcare infrastructure are key drivers of market growth.
• High costs and regulatory challenges are significant restraints to market growth.
• The market is expected to continue growing, driven by advancements in drug delivery technologies and increasing demand for effective treatments.

Frequently Asked Questions

What is the current market size of the octreotide acetate market?

The global octreotide acetate market was valued at approximately USD 3.08 billion in 2023[1].

What is the projected growth rate of the octreotide acetate market?

The market is projected to grow at a CAGR of 3.1% from 2024 to 2031[1].

Which region is expected to be the fastest-growing market for octreotide acetate?

The Asia-Pacific region is anticipated to be the fastest-growing market, driven by increasing healthcare expenditures and rising chronic disease rates[1][3][4].

What are the key drivers of growth in the octreotide acetate market?

The key drivers include the rising prevalence of endocrine and neuroendocrine disorders, innovations in drug formulations, and expanding healthcare infrastructure in emerging economies[3][4].

What are the major restraints to the growth of the octreotide acetate market?

The major restraints include high costs associated with octreotide therapies, regulatory challenges, and potential side effects[4].

Cited Sources

1. Verified Market Research - Octreotide Acetate Market Size, Share, Scope, Trends & Forecast[1].
2. PubMed - The cost-effectiveness of octreotide acetate in the treatment of carcinoid syndrome and VIPoma[2].
3. Data Horizon Research - Octreotide Market Size, Share & Forecast 2033[3].
4. Global Growth Insights - Octreotide Market Share, Forecast [2032][4].
5. DrugBank Online - Octreotide: Uses, Interactions, Mechanism of Action[5].