MYCAPSSA Drug Patent Profile

Which patents cover Mycapssa, and what generic alternatives are available?

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

This drug has sixty-seven patent family members in twenty-six 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:	67
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	2
Patent Applications:	3,987
Drug Prices:	Drug price information 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 fourteen 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	11,052,126
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	8,535,695
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	8,329,198		Y
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	11,857,595

International Patents for MYCAPSSA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2975599	METHODE DE TRAITEMENT DE MALADIES (METHOD OF TREATING DISEASES)
Israel	211799	תכשירי רוקחות ושיטות להעברתם הקשורות להן (Pharmaceutical compositions and related methods of delivery)
Japan	2016074733	医薬組成物および関連する送達方法 (PHARMACEUTICAL COMPOSITION, AND RELATED DELIVERY METHOD)
San Marino	T201700304
South Korea	101683314

Market Dynamics and Financial Trajectory for MYCAPSSA

Introduction

MYCAPSSA®, an oral somatostatin analog developed by Chiasma Inc. and later acquired by Amryt Pharmaceuticals, has been a significant player in the treatment of acromegaly, a rare hormonal disorder. Here, we delve into the market dynamics and financial trajectory of MYCAPSSA, highlighting its growth, challenges, and future prospects.

Market Need and Demand

Acromegaly, a condition resulting from excess growth hormone production, affects a small but significant population globally. The global prevalence of acromegaly ranges from 1 in 7,500 to 1 in 35,800 people, with an annual incidence between 1 in 91,000 to 1 in 526,000 people[4].

Product Overview

MYCAPSSA is the first FDA-approved oral formulation of octreotide for the treatment of acromegaly, offering an alternative to traditional injectable somatostatin analogs (SSAs). This oral therapy reduces the burden of chronic injections, improving patient compliance and quality of life[2][3].

Launch and Initial Performance

The phased U.S. commercial launch of MYCAPSSA began in September 2020. In the first full quarter of sales, net product revenue was approximately $1.0 million, with total 2020 revenue reaching $1.1 million[2].

Revenue Growth

Since its launch, MYCAPSSA has shown significant revenue growth. In Q4 2021, MYCAPSSA revenues were $5.0 million, a substantial increase from $1.4 million in Q3 2021. This growth continued into 2022, with Q3 2022 revenues increasing by 26.9% quarter-over-quarter (QoQ) and 292.8% year-over-year (YoY) to $5.7 million[1][5].

Market Expansion and Regulatory Approvals

U.S. Market

The U.S. market has been a key driver for MYCAPSSA's revenue. The drug has achieved payor coverage for over 150 million lives, facilitating broader access to patients[2].

European Market

Amryt received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for MYCAPSSA in the EU, paving the way for European regulatory approval. A Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMA) in mid-2021[2][5].

Clinical Trials and Future Indications

MYCAPSSA is not only being explored for its current indication in acromegaly but also for potential use in treating carcinoid symptoms due to neuroendocrine tumors (NET). A successful bioavailability study has supported the planned initiation of a Phase 3 study for this additional indication, expected to start in Q1 2023[1][5].

Financial Impact on Amryt Pharmaceuticals

The acquisition of Chiasma and the integration of MYCAPSSA have significantly impacted Amryt's financials. In FY 2021, Amryt reported a 22% growth in revenues to $222.5 million, with MYCAPSSA contributing to this growth. The company also refinanced its term debt facilities, reducing interest costs and extending the maturity profile through 2027[1].

Operating Expenses and EBITDA

Despite the growth in revenue, operating expenses, including research and development (R&D) and selling, general, and administrative (SG&A) costs, have been substantial. However, Amryt has maintained positive EBITDA generation for 11 consecutive quarters, with $12.5 million in Q3 2022[5].

Market Size and Growth Potential

The acromegaly treatment market, valued at $2.2 billion in 2023, is expected to grow at a CAGR of 5.4% from 2024 to 2032. Medical therapy, which includes somatostatin analogs like MYCAPSSA, holds the largest market share of 45.7% and is expected to maintain dominance throughout the forecast period[4].

Competitive Landscape

MYCAPSSA competes with traditional injectable SSAs, which are the current standard of care for acromegaly and NET patients. However, its oral formulation offers a unique advantage in terms of patient compliance and convenience, positioning it favorably in the market[1][3].

Challenges and Opportunities

Challenges

• High R&D and SG&A expenses associated with the commercialization and expansion of MYCAPSSA.
• Competition from established injectable therapies.
• Regulatory hurdles in expanding indications and geographic reach.

Opportunities

• Growing demand for advanced and convenient treatments for rare diseases.
• Potential new market opportunities with the planned Phase 3 study for NET.
• Strong payor coverage and regulatory approvals in key markets.

Key Takeaways

• MYCAPSSA has shown significant revenue growth since its launch, driven by its unique oral formulation and expanding market reach.
• The drug has received positive regulatory opinions and is poised for further growth with potential new indications.
• Amryt Pharmaceuticals has integrated MYCAPSSA successfully, contributing to the company's overall revenue growth and financial stability.
• The acromegaly treatment market is expected to grow, driven by increasing awareness and demand for advanced therapies.

FAQs

What is MYCAPSSA used for?

MYCAPSSA is used for the treatment of acromegaly, a rare hormonal disorder resulting from excess growth hormone production. It is the first FDA-approved oral formulation of octreotide for this condition.

How has MYCAPSSA performed financially since its launch?

MYCAPSSA has shown significant revenue growth since its launch in 2020. In Q4 2021, revenues were $5.0 million, and in Q3 2022, revenues increased by 26.9% QoQ and 292.8% YoY to $5.7 million.

What are the potential new indications for MYCAPSSA?

MYCAPSSA is being explored for the treatment of carcinoid symptoms due to neuroendocrine tumors (NET), with a planned Phase 3 study expected to start in Q1 2023.

How does MYCAPSSA compare to traditional treatments for acromegaly?

MYCAPSSA offers an oral formulation, which is a significant advantage over traditional injectable somatostatin analogs, improving patient compliance and quality of life.

What is the projected market size for the acromegaly treatment market?

The acromegaly treatment market was valued at $2.2 billion in 2023 and is expected to grow at a CAGR of 5.4% from 2024 to 2032, reaching $3.5 billion by 2032.

Sources

1. GlobeNewswire: Amryt Announces 22% growth in FY 2021 Revenues to $222.5M
2. Biospace: Chiasma Reports Fourth Quarter and Full-Year 2020 Financial Results and Provides Corporate Update
3. AnnualReports.com: CHIASMA ANNUAL REPORT 2015
4. GMI Insights: Acromegaly Treatment Market Size & Share Report, 2032
5. Investis: Amryt Reports Q3 2022 Financial and Operational Results