LUNESTA Drug Patent Profile

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

Lunesta is a drug marketed by Waylis Therap and is included in one NDA.

The generic ingredient in LUNESTA is eszopiclone. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lunesta

A generic version of LUNESTA was approved as eszopiclone by TEVA on May 23^rd, 2011.

Summary for LUNESTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	46
Patent Applications:	3,752
Drug Prices:	Drug price information for LUNESTA
What excipients (inactive ingredients) are in LUNESTA?	LUNESTA excipients list
DailyMed Link:	LUNESTA at DailyMed

See drug prices for LUNESTA

See drug sales revenues for LUNESTA

Recent Clinical Trials for LUNESTA

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

Sponsor	Phase
American Academy of Sleep Medicine	Phase 2
Laboratorios Andromaco S.A.	Phase 1
University of California, San Diego	Phase 2

See all LUNESTA clinical trials

Paragraph IV (Patent) Challenges for LUNESTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUNESTA	Tablets	eszopiclone	1 mg, 2 mg and 3 mg	021476	10	2008-12-15

US Patents and Regulatory Information for LUNESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004	AB	RX	Yes	No
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	AB	RX	Yes	No
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	AB	RX	Yes	Yes

Expired US Patents for LUNESTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	6,444,673*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	6,319,926*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	6,319,926*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004	6,319,926*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	6,864,257*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	6,864,257*PED

International Patents for LUNESTA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0609210	DERIVE DE LA 5H-PYRROLO[3,4-b]PYRAZINE OPTIQUEMENT ACTIF, SA PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LE CONTIENNENT. (OPTICALLY ACTIVE 5H-PYRROLO[3,4-b]PYRAZINE DERIVATIVE, ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT.)
Australia	3032195
European Patent Office	0495717
Slovakia	71993	OPTICALY ACTIVE 5H-PYRROLO[3,4-B]PYRAZINE DERIVATIVE, ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME
Ireland	920126
Finland	100331

LUNESTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: LUNESTA

Introduction

LUNESTA, known generically as eszopiclone, is a non-benzodiazepine sedative hypnotic used for the treatment of insomnia. Developed by Sunovion Pharmaceuticals Inc., it was launched in the U.S. in 2005. Here, we delve into the market dynamics and financial trajectory of LUNESTA over the years.

Approval and Initial Success

LUNESTA was approved by the FDA in 2005 and quickly gained traction in the insomnia treatment market. By the time it was a year old, it had already generated significant revenue. In its first year, LUNESTA showed promising sales, setting the stage for its future growth[4].

Peak Sales and Market Position

At its peak, LUNESTA achieved substantial sales figures. For instance, in the year preceding the introduction of generic competitors, LUNESTA's U.S. sales were approximately $567 million[1]. This made it one of the leading prescription sleep aids in the market.

Impact of Generic Competition

The introduction of generic versions of rival sleep aids, such as Ambien, significantly impacted LUNESTA's sales. Generic Ambien, introduced in the spring of 2007, led to a decline in LUNESTA's U.S. sales as patients and prescribers opted for the cheaper alternative. This competition forced Sepracor, the original developer of LUNESTA, to seek new marketing strategies to maintain market share[1].

International Marketing Strategies

To counter the decline in U.S. sales, Sepracor entered into a marketing agreement with GlaxoSmithKline (GSK) to market LUNESTA under the brand name Lunivia in Europe and Japan. This deal included an initial payment of $20 million and potential milestone payments up to $155 million. The European insomnia market, estimated at $500 million, presented a significant opportunity for growth[1].

Financial Performance Over the Years

• Peak Revenue: LUNESTA's U.S. sales peaked at around $567 million in the year before generic competition intensified[1].
• Decline: Following the introduction of generic Ambien, LUNESTA's sales declined. For example, in the fourth quarter of 2008, LUNESTA revenues were $162 million, indicating a significant drop from its peak[5].
• International Revenue: Although specific figures for Lunivia's sales in Europe and Japan are not readily available, the potential for significant revenue was high given the large insomnia market in these regions[1].

Divestiture and Reallocation of Resources

In December 2022, Sumitomo Pharma, the parent company of Sunovion, announced the divestiture of its rights to LUNESTA to Woodward Pharma Services LLC in all countries except Canada. This move was part of a strategic reallocation of resources to focus on medium- and long-term growth areas, aiming to improve profitability[4].

Financial Implications of Divestiture

The divestiture of LUNESTA rights was recorded as other operating income in the third quarter of the fiscal year ending March 31, 2023, and was already factored into Sumitomo Pharma's financial forecast. This move indicates a shift in the company's focus towards more lucrative and growth-oriented opportunities[4].

Market Dynamics and Competition

The insomnia treatment market is highly competitive, with several drugs vying for market share. The introduction of new treatments like Quviviq (daridorexant) has further intensified competition. Quviviq, approved in 2022, targets a different biological mechanism and has shown promising early sales figures, potentially challenging established players like LUNESTA[3].

Future Outlook

Given the divestiture and the competitive landscape, LUNESTA's future financial trajectory under Woodward Pharma Services LLC will depend on several factors, including marketing strategies, pricing, and the ability to maintain or regain market share. The overall insomnia treatment market is projected to grow, with the U.S. market expected to total $6.3 billion by 2030, providing opportunities for existing and new treatments alike[3].

Key Takeaways

• LUNESTA was a highly successful sleep aid upon its launch in 2005.
• The introduction of generic competitors significantly impacted its sales.
• International marketing agreements were sought to boost revenue.
• The divestiture of LUNESTA rights marks a strategic shift for Sumitomo Pharma.
• The insomnia treatment market remains competitive with new entrants like Quviviq.

FAQs

What is LUNESTA used for?

LUNESTA, known generically as eszopiclone, is used for the treatment of insomnia, helping patients fall asleep and stay asleep.

When was LUNESTA approved?

LUNESTA was approved by the FDA in 2005.

How did generic competition affect LUNESTA's sales?

The introduction of generic versions of rival sleep aids, such as Ambien, led to a significant decline in LUNESTA's U.S. sales as patients and prescribers opted for the cheaper alternatives.

What was the international marketing strategy for LUNESTA?

Sepracor entered into a marketing agreement with GlaxoSmithKline to market LUNESTA under the brand name Lunivia in Europe and Japan.

Who currently holds the rights to LUNESTA?

As of December 2022, Woodward Pharma Services LLC holds the rights to LUNESTA in all countries except Canada, following a divestiture agreement with Sumitomo Pharma.

What is the projected market size for insomnia treatments by 2030?

The overall insomnia treatment market in the U.S. is projected to total $6.3 billion by 2030[3].