MYCAPSSA Drug Patent Profile

When do Mycapssa patents expire, and when can generic versions of Mycapssa launch?

Mycapssa is a drug marketed by Chiesi and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-one patent family members in twenty-nine countries.

The generic ingredient in MYCAPSSA is octreotide acetate. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycapssa

A generic version of MYCAPSSA was approved as octreotide acetate by WEST-WARD PHARMS INT on April 8^th, 2005.

Summary for MYCAPSSA

International Patents:	81
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	2
Drug Prices:	Drug price information for MYCAPSSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYCAPSSA
What excipients (inactive ingredients) are in MYCAPSSA?	MYCAPSSA excipients list
DailyMed Link:	MYCAPSSA at DailyMed

See drug prices for MYCAPSSA

Recent Clinical Trials for MYCAPSSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chiasma, Inc.	Phase 3

See all MYCAPSSA clinical trials

Pharmacology for MYCAPSSA

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Paragraph IV (Patent) Challenges for MYCAPSSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYCAPSSA	Delayed-release Capsules	octreotide acetate	20 mg	208232	1	2023-12-29

US Patents and Regulatory Information for MYCAPSSA

MYCAPSSA is protected by sixteen US patents and one FDA Regulatory Exclusivity.

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	11,338,011
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	10,238,709
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	11,141,457
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	11,986,529
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	11,510,963
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	9,566,246		Y
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	8,329,198		Y

International Patents for MYCAPSSA

See the table below for patents covering MYCAPSSA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2343982	PRÉPARATIONS PHARMACEUTIQUES ET MÉTHODES ASSOCIÉES D'ADMINISTRATION (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY)
Hong Kong	1243597
United Kingdom	0916349
Japan	2014074069	PHARMACEUTICAL COMPOSITION, AND RELATED DELIVERY METHOD
United Kingdom	2482810
Poland	2343982
Lithuania	3253401

Market Dynamics and Financial Trajectory for MYCAPSSA

Last updated: July 28, 2025

Introduction

MYCAPSSA (octreotide capsules) is a novel oral formulation designed to treat acromegaly, a rare hormonal disorder characterized by excess growth hormone secretion. Approved by the FDA in 2020, MYCAPSSA represents a strategic advancement in the management of acromegaly, offering an alternative to injectable somatostatin analogs. This article explores the evolving market landscape, competitive positioning, financial potential, and key factors shaping the trajectory of MYCAPSSA within the pharmaceutical industry.

---

Market Overview and Disease Epidemiology

Acromegaly affects approximately 3 to 14 cases per million annually (1). The primary therapeutic goal involves controlling excessive growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, preventing morbidity, and improving quality of life. The conventional treatment paradigm relies heavily on long-acting injectable somatostatin analogs, such as octreotide LAR and lanreotide, which have demonstrated efficacy but are often associated with injection-site discomfort, adherence issues, and reduced patient compliance (2).

The emerging need for patient-centric, non-invasive treatment options has propelled the development of oral therapies like MYCAPSSA. The global market size for acromegaly drugs was valued at approximately USD 500 million in 2021 and is projected to grow at a compounded annual growth rate (CAGR) of around 8% over the next five years, driven by increased diagnosis rates and advances in personalized management strategies (3).

---

Market Dynamics Influencing MYCAPSSA

1. Unmet Medical Needs and Patient Preferences

The shift towards oral medications in endocrine disorders reflects a broader trend favoring improved convenience and adherence. MYCAPSSA addresses a significant unmet need by offering an oral alternative to injectable therapies, which historically have posed compliance challenges. The patient preference for non-invasive treatment modalities could significantly expand the drug's adoption, especially among younger and needle-averse populations.

2. Competitive Landscape

Currently, the market for acromegaly treatment predominantly includes injectable somatostatin analogs (octreotide LAR, lanreotide), with few oral options. Pasireotide (Signifor), another somatostatin analog, is available in injectable form, but no oral mimetics have received approval for acromegaly outside MYCAPSSA. The limited competition enhances MYCAPSSA’s market potential, although later entrants with similar formulations or biosimilars could challenge its dominance.

3. Regulatory and Reimbursement Environment

Since its approval, MYCAPSSA has benefited from regulatory exclusivity, allowing for initial market penetration. Payers are increasingly emphasizing value-based care, favoring treatments that improve adherence and reduce healthcare utilization. Cost considerations, especially in the context of oral formulations requiring less frequent clinic visits, position MYCAPSSA favorably for reimbursement negotiations.

4. Manufacturing and Supply Chain Factors

The complexity of formulating a stable, bioavailable oral octreotide capsule involves overcoming challenges related to peptide stability and gastrointestinal absorption. Persistent investments in manufacturing processes and supply chain resilience are critical for maintaining product availability and control over costs.

---

Financial Trajectory and Revenue Outlook

Revenue Generation Potential

Given the size and growth estimated of the acromegaly market, MYCAPSSA's sales potential hinges on several factors:

• Market Penetration Rate: Initial uptake depends on prescriber acceptance, patient adoption, and insurance reimbursement policies. Early adoption by endocrinologists and specialty clinics will be pivotal.
• Pricing Strategy: As a novel oral therapy, MYCAPSSA commands premium pricing. Estimated wholesale acquisition costs (WAC) may be in the range of USD 20,000–30,000 annually per patient, reflecting its innovative formulation.
• Market Penetration Timeline: First-year sales are expected to be modest, roughly USD 50–100 million, expanding significantly as awareness increases and formulary access broadens.

Growth Drivers and Barriers

• Expansion into New Markets: Beyond the U.S., regions such as Europe, Asia-Pacific, and Latin America represent substantial growth opportunities. Regulatory approvals in these territories are underway or pending.
• Patient and Physician Adoption: Education campaigns highlighting benefits over traditional injections and clinical data supporting efficacy and safety will accelerate uptake.
• Cost and Reimbursement Challenges: High drug costs may face resistance, particularly where alternative treatments are more established. Payers’ willingness to reimburse will influence revenue growth.

Long-term Financial Outlook

Based on current trajectory, MYCAPSSA could reach peak sales of USD 300–500 million globally within five years if penetration and access expand as expected. The company's ongoing investments in clinical development, marketing, and distribution logistics will influence profitability timelines. Moreover, patent protections until at least 2030 provide a period of market exclusivity that supports pricing strategies and revenue stability.

---

Market Risks and Opportunities

Risks

• Clinical and Regulatory set-backs: Any delays or setbacks in approval for additional indications or post-market surveillance issues could dampen prospects.
• Competitive Entry: Emergence of alternative oral formulations or biosimilars could erode market share.
• Pricing Pressure: Payers seeking cost reductions may impose formulary restrictions impacting sales.

Opportunities

• Expanding Indications: Potential future approvals for other peptide hormones or related disorders could diversify revenue streams.
• Combination Therapies: Integration with other treatment modalities may improve efficacy and patient outcomes.
• Digital and Patient Engagement: Leveraging telemedicine and performance analytics can foster sustained adherence and patient satisfaction.

---

Conclusion

MYCAPSSA is positioned at the forefront of transforming acromegaly management through its innovative oral delivery platform. Its market dynamics are shaped by evolving patient preferences, limited current competition, and regulatory support. While revenue growth prospects are promising, the trajectory depends on successful commercialization, market acceptance, and global expansion. As the first oral somatostatin analog, MYCAPSSA offers significant upside potential but faces inherent challenges associated with novel formulations and market penetration.

---

Key Takeaways

• MYCAPSSA fills a critical unmet need by providing an oral alternative to injectable acromegaly therapies, aligning with a broader shift toward patient-centric treatments.
• The drug’s market growth is supported by increasing disease awareness, premium pricing strategies, and early adoption by specialists.
• Market risks include potential competition, pricing pressures, and regulatory hurdles, which require strategic mitigation.
• Long-term success hinges on expanding formulary access, international approvals, and educating physicians and patients on its benefits.
• With a targeted approach, MYCAPSSA could achieve peak sales exceeding USD 300 million globally within five years, supporting sustained revenue and profitability.

---

FAQs

1. What differentiates MYCAPSSA from traditional acromegaly treatments?
MYCAPSSA offers an oral formulation of octreotide, providing a non-invasive alternative to injections, which improves patient compliance and comfort.

2. How does the efficacy of MYCAPSSA compare to injectable analogs?
Clinical trials demonstrate that MYCAPSSA achieves comparable reductions in GH and IGF-1 levels, with similar safety profiles, as established in phase 3 studies (4).

3. What are the main challenges in marketing MYCAPSSA globally?
Regulatory approvals, reimbursement negotiations, establishing physician familiarity, and educating patients about its benefits are key challenges to global expansion.

4. Can MYCAPSSA be used for other indications beyond acromegaly?
Currently, MYCAPSSA is approved specifically for acromegaly. Future research may explore its potential in other peptide hormone-related disorders.

5. How does patient adherence to MYCAPSSA influence its market success?
High adherence rates are anticipated due to the convenience of oral administration, which can lead to better disease control and increased physician confidence in prescribing.

---

References

[1] Melmed S. et al. "Acromegaly:advances in diagnosis and treatment." Endocrine Reviews, 2021.
[2] Colao A., et al. "Managing acromegaly: an overview and clinical update." Journal of Clinical Endocrinology & Metabolism, 2020.
[3] MarketWatch. "Global Acromegaly Drugs Market Size, Share & Trends." 2022.
[4] Melmed S., et al. "Efficacy and safety of oral octreotide in acromegaly." Lancet Diabetes & Endocrinology, 2021.