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VYLEESI (AUTOINJECTOR) Drug Patent Profile

When do Vyleesi (autoinjector) patents expire, and what generic alternatives are available?

Vyleesi (autoinjector) is a drug marketed by Cosette and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. One supplier is listed for this compound. Additional details are available on the bremelanotide acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vyleesi (autoinjector)

Vyleesi (autoinjector) was eligible for patent challenges on June 21, 2023.

Indicators of Generic Entry

Summary for VYLEESI (AUTOINJECTOR)

International Patents:	81
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	VYLEESI (AUTOINJECTOR) at DailyMed

Pharmacology for VYLEESI (AUTOINJECTOR)

Drug Class	Melanocortin Receptor Agonist
Mechanism of Action	Melanocortin Receptor Agonists

US Patents and Regulatory Information for VYLEESI (AUTOINJECTOR)

VYLEESI (AUTOINJECTOR) is protected by five 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
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	9,352,013
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	10,286,034
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019		RX	Yes	Yes	11,590,209

Expired US Patents for VYLEESI (AUTOINJECTOR)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	VYLEESI (AUTOINJECTOR)	bremelanotide acetate	SOLUTION;SUBCUTANEOUS	210557-001	Jun 21, 2019	6,579,968

International Patents for VYLEESI (AUTOINJECTOR)

See the table below for patents covering VYLEESI (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
China	104755094	Uses of Bremelanotide in therapy for female sexual dysfunction
Mexico	PA02000111	COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE DISFUNCION SEXUAL. (COMPOSITIONS AND METHODS FOR TREATMENT OF SEXUAL DYSFUNCTION.)
Canada	2574605

VYLEESI (AUTOINJECTOR) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vyleesi (Autoinjector)

Introduction

Vyleesi, a melanocortin receptor agonist, was approved by the FDA in 2019 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Despite its innovative mechanism of action and the significant market potential, the drug has faced several challenges in its market trajectory.

FDA Approval and Initial Launch

Vyleesi was approved by the FDA on June 21, 2019, as the first as-needed treatment for premenopausal women with HSDD. The drug is administered via a prefilled autoinjector pen and can be self-administered at least 45 minutes before anticipated sexual activity[4].

Licensing and Partnership History

Palatin Technologies initially licensed Vyleesi to AMAG Pharmaceuticals in February 2017. This agreement included a $60 million payment to Palatin upon FDA approval, tiered royalties on annual net sales, and sales milestones based on escalating annual net sales thresholds[4].

However, in 2020, AMAG and Palatin mutually agreed to terminate the licensing agreement, with AMAG paying Palatin $12 million upfront and an additional $4.3 million in March 2021[1].

Market Performance

Since its launch, Vyleesi has not met the initial sales expectations. Here are some key metrics:

• Initial Launch: By four weeks post-launch in September 2019, more than 3,000 Vyleesi prescriptions were written across over 1,300 prescribing healthcare providers[3].
• Fiscal Year 2022: Gross product sales were $5.8 million, with net product revenue of $1.2 million[5].
• Fiscal Year 2023: Gross product sales increased to $12.5 million, with net product revenue of $4.9 million, indicating a significant growth but still far below initial projections[5].

Sales Milestones and Revenue

Despite the growth, the sales figures are significantly lower than what was anticipated. For example, Barclays’ analyst Balaji Prasad had predicted potential sales of $108 million by 2025, which seems unlikely given the current trend[1].

• Quarterly Performance: In the fiscal third quarter of 2023, gross product revenue was $3.4 million, and net product revenue was $1.2 million, showing increases over the prior quarter and the comparable quarter in 2022[2].
• Total Prescriptions: Total prescriptions dispensed have shown positive trends, increasing by 27% over the prior quarter and 147% over the comparable quarter in 2022[2].

Financial Trajectory

The financial performance of Vyleesi has been a mixed bag:

• Revenue Growth: While there has been a significant increase in gross product sales and net product revenue from 2022 to 2023, the absolute numbers are still modest. For the fiscal year ended June 30, 2023, gross product sales were $12.5 million, and net product revenue was $4.9 million[5].
• Operating Expenses: Despite the revenue growth, Vyleesi's quarterly operating expenses have been a challenge. However, Palatin has reported that Vyleesi's net product revenue continues to exceed its quarterly operating expenses[5].

Divestiture and New Ownership

In December 2023, Palatin Technologies sold Vyleesi to Cosette Pharmaceuticals for $12 million upfront and up to $159 million in contingent, sales-based milestones. This move aligns with Palatin's strategic decision to focus on its development and clinical pipeline, particularly on novel therapeutics modulating the melanocortin receptor system[1].

Market Potential and Challenges

Vyleesi addresses a significant market need, as approximately 6 million premenopausal women in the U.S. suffer from HSDD. However, the drug has faced challenges in gaining traction:

• Competition: Vyleesi competes with Addyi, another treatment for HSDD approved in 2015. Addyi has had its own set of challenges, including changes in ownership and marketing strategies[1].
• Safety Concerns: Vyleesi is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease, which may limit its adoption in certain patient populations[4].

Future Outlook

Under Cosette Pharmaceuticals, Vyleesi may see a renewed marketing and sales strategy. Cosette's CEO, Apurva Saraf, has expressed enthusiasm about Vyleesi as an important addition to their women’s health platform[1].

Key Statistics

• Prescriptions: Over 3,000 prescriptions written within four weeks of launch[3].
• Revenue Growth: Gross product sales increased from $5.8 million in FY 2022 to $12.5 million in FY 2023[5].
• Milestones: Up to $159 million in contingent, sales-based milestones with Cosette Pharmaceuticals[1].

Conclusion

Vyleesi's market dynamics and financial trajectory have been marked by both growth and challenges. Despite its innovative approach to treating HSDD, the drug has not yet achieved the sales projections initially anticipated. The divestiture to Cosette Pharmaceuticals may offer a new chapter in its market life, but it remains to be seen how effectively the new owner can leverage Vyleesi's potential.

Key Takeaways

• Vyleesi is the first FDA-approved as-needed treatment for premenopausal women with HSDD.
• The drug has shown revenue growth but has not met initial sales expectations.
• Palatin Technologies divested Vyleesi to Cosette Pharmaceuticals in December 2023.
• Vyleesi faces competition from other treatments like Addyi and has specific safety contraindications.
• The new ownership may bring a fresh marketing and sales strategy to the drug.

FAQs

Q: What is Vyleesi used for? A: Vyleesi is used for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Q: How is Vyleesi administered? A: Vyleesi is administered via a prefilled autoinjector pen, self-administered into the abdomen or thigh at least 45 minutes before anticipated sexual activity[4].

Q: Who currently owns the rights to Vyleesi? A: As of December 2023, Cosette Pharmaceuticals owns the rights to Vyleesi after purchasing it from Palatin Technologies[1].

Q: What were the initial sales projections for Vyleesi? A: Initial projections by Barclays’ analyst Balaji Prasad suggested potential sales of $108 million by 2025, which has not been achieved[1].

Q: What are the safety concerns associated with Vyleesi? A: Vyleesi is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease[4].

Sources

1. FiercePharma: Cosette buys female libido drug Vyleesi from divesting Palatin[1].
2. Palatin Technologies: Preliminary Third Quarter Fiscal 2023 Vyleesi Product Revenue Results[2].
3. Business Insider: AMAG Pharmaceuticals Announces Third Quarter 2019 Financial Results and Provides Corporate Update[3].
4. GlobeNewswire: AMAG Pharmaceuticals Announces FDA Approval of Vyleesi™[4].
5. PR Newswire: Palatin Reports Fourth Quarter and Fiscal Year Ended 2023 Financial Results and Provides Corporate Update[5].