Bremelanotide acetate - Generic Drug Details

What are the generic drug sources for bremelanotide acetate and what is the scope of freedom to operate?

Bremelanotide acetate is the generic ingredient in one branded drug marketed by Cosette and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bremelanotide acetate has eighty-one patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for bremelanotide acetate

International Patents:	81
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	bremelanotide acetate at DailyMed

Recent Clinical Trials for bremelanotide acetate

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

Sponsor	Phase
Palatin Technologies, Inc	Phase 2

See all bremelanotide acetate clinical trials

Pharmacology for bremelanotide acetate

Drug Class	Melanocortin Receptor Agonist
Mechanism of Action	Melanocortin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for bremelanotide acetate

G02CX	Other gynecologicals
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for bremelanotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes			Y	Y
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes

Expired US Patents for bremelanotide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019

International Patents for bremelanotide acetate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005014617
Japan	4576493
European Patent Office	1667700
World Intellectual Property Organization (WIPO)	03006620
European Patent Office	1593384

Bremelanotide acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bremelanotide Acetate

Introduction

Bremelanotide acetate, marketed under the brand name Vyleesi, is a synthetic peptide analog of alpha-melanocyte stimulating hormone (a-MSH) that has garnered significant attention for its therapeutic applications, particularly in treating hypoactive sexual desire disorder (HSDD) in premenopausal women. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The Bremelanotide API market has been experiencing substantial growth, driven by increasing demand for treatments of sexual dysfunction and other potential therapeutic applications. As of 2023, the market size was valued in billions of USD, and it is anticipated to continue growing significantly until 2031. This growth is attributed to the expanding need for effective treatments in the women's health sector and the drug's potential in other therapeutic areas such as obesity and diabetic kidney disease[3].

Market Segmentation

The Bremelanotide API market is segmented based on type (Type I, Type II, Type III, Type IV), application (injection and others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and identifying key growth areas. For instance, the injection segment is particularly significant due to the subcutaneous route of administration for Vyleesi[3].

Key Players and Partnerships

The market for bremelanotide acetate involves several key players, including Palatin Technologies, AMAG Pharmaceuticals, and more recently, Cosette Pharmaceuticals. Palatin Technologies has been at the forefront of developing bremelanotide, and in 2017, they partnered with AMAG Pharmaceuticals to complete the development and marketing of the drug in North America. This partnership included significant upfront payments, regulatory milestones, and sales milestones, highlighting the financial commitment and potential returns in this market[1].

Financial Trajectory

The financial trajectory of bremelanotide acetate is marked by significant investments and potential returns. Here are some key financial milestones:

• Development and Licensing: Palatin Technologies received $60 million upfront from AMAG Pharmaceuticals, along with up to $80 million in regulatory milestones and up to $300 million in sales milestones. Additionally, Palatin is entitled to tiered royalties ranging from high single-digit to low double-digit percentages[1].
• Market Launch: The approval and launch of Vyleesi in 2019 marked a crucial financial milestone, opening up revenue streams from sales.
• Projected Growth: The market is expected to grow substantially from 2023 to 2031, driven by increasing demand and potential approvals for additional indications such as obesity and diabetic kidney disease[3].

Clinical Development and Regulatory Approvals

Bremelanotide acetate has undergone extensive clinical trials, particularly for the treatment of HSDD. The drug was approved by the FDA in 2019 for this indication, following successful Phase III trials. The approval process involved addressing safety concerns, such as transient increases in blood pressure and focal hyperpigmentation, which are now managed through labeling and postmarketing surveillance[2][5].

Emerging Indications

Beyond HSDD, bremelanotide acetate is being explored for other therapeutic applications, including obesity and diabetic kidney disease. Cosette Pharmaceuticals is currently conducting Phase II trials for obesity, which, if successful, could significantly expand the market for this drug. The likelihood of approval for these new indications is critical for the drug's financial trajectory, with Phase II drugs for obesity having a 29% phase transition success rate[4].

Safety and Adverse Reactions

The safety profile of bremelanotide acetate is a crucial factor in its market dynamics. Common adverse reactions include nausea, transient increases in blood pressure, and focal hyperpigmentation. These side effects are generally mild to moderate and transient, but they require careful management to ensure patient safety. The FDA has mandated postmarketing studies to monitor long-term safety, particularly regarding pregnancy outcomes and liver toxicity[2][5].

Market Opportunities and Challenges

The market for bremelanotide acetate presents several opportunities and challenges:

• Opportunities: Expanding into new therapeutic areas, increasing awareness and demand for treatments of sexual dysfunction, and potential partnerships with other pharmaceutical companies.
• Challenges: Managing safety concerns, competing with other treatments for similar indications, and navigating regulatory hurdles for new indications[3][4].

Key Takeaways

• Growing Market: The Bremelanotide API market is expected to grow significantly until 2031, driven by increasing demand and potential new indications.
• Financial Commitment: Significant investments have been made in the development and marketing of bremelanotide acetate, with potential for substantial returns.
• Clinical Development: The drug has been approved for HSDD and is being explored for other therapeutic applications.
• Safety Management: Careful management of adverse reactions is essential for maintaining a favorable safety profile.

FAQs

What is bremelanotide acetate used for?

Bremelanotide acetate, marketed as Vyleesi, is primarily used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.

How is bremelanotide acetate administered?

The drug is administered via a subcutaneous auto-injector.

What are the common side effects of bremelanotide acetate?

Common side effects include nausea, transient increases in blood pressure, and focal hyperpigmentation.

Is bremelanotide acetate being explored for other indications?

Yes, it is being explored for obesity and diabetic kidney disease, among other potential therapeutic applications.

Who are the key players involved in the development and marketing of bremelanotide acetate?

Key players include Palatin Technologies, AMAG Pharmaceuticals, and Cosette Pharmaceuticals.

Sources

1. Wikipedia: Bremelanotide
2. FDA: Vyleesi (Bremelanotide Injection) Label
3. Market Research Intellect: Global Bremelanotide API Market Size, Scope And Forecast Report
4. Pharmaceutical Technology: Bremelanotide acetate by Cosette Pharmaceuticals for Obesity
5. FDA: NDA 210557 - Vyleesi (Bremelanotide) Multidiscipline Review and Evaluation Standard