EDLUAR Drug Patent Profile

Which patents cover Edluar, and when can generic versions of Edluar launch?

Edluar is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty patent family members in twelve countries.

The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Edluar

A generic version of EDLUAR was approved as zolpidem tartrate by ACME LABS on April 23^rd, 2007.

Summary for EDLUAR

International Patents:	20
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Patent Applications:	515
Drug Prices:	Drug price information for EDLUAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDLUAR
What excipients (inactive ingredients) are in EDLUAR?	EDLUAR excipients list
DailyMed Link:	EDLUAR at DailyMed

See drug prices for EDLUAR

Pharmacology for EDLUAR

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists
Physiological Effect	Central Nervous System Depression

Paragraph IV (Patent) Challenges for EDLUAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EDLUAR	Sublingual Tablets	zolpidem tartrate	5 mg and 10 mg	021997	1	2010-04-29

US Patents and Regulatory Information for EDLUAR

EDLUAR is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	AB	RX	Yes	No
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	AB	RX	Yes	Yes
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	AB	RX	Yes	No
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	AB	RX	Yes	Yes

Expired US Patents for EDLUAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009

International Patents for EDLUAR

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1107711
Poland	347126
Norway	20011473
Poland	201644

Supplementary Protection Certificates for EDLUAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132	484	Finland
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES

EDLUAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EDLUAR

Introduction to EDLUAR

EDLUAR is a pharmaceutical formulation of zolpidem tartrate, designed for the short-term treatment of insomnia characterized by difficulties with falling asleep. It is the first available under-the-tongue (sublingual) formulation of zolpidem tartrate, offering a convenient and rapid absorption profile for patients[4].

Market Context: Insomnia Treatment

The insomnia market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) is expected to grow at a compound annual growth rate (CAGR) of 2.6% from $3.2 billion in 2022 to $4.1 billion in 2032. This growth is driven by the increasing patient share of dual orexin receptor antagonists (DORAs) and the introduction of new pipeline products[1].

Competitive Landscape

EDLUAR enters a market dominated by traditional hypnotics, including Z-drugs, benzodiazepines, and low-dose sedating antidepressants. However, DORAs such as Merck’s Belsomra (suvorexant), Eisai’s Dayvigo (lemborexant), and Idorsia’s Quviviq (daridorexant) have been gaining patient share since their launches. These newer drugs are expected to continue their sales growth at a CAGR of 8.6% to 2032[1].

Unique Selling Points of EDLUAR

• Convenience and Rapid Absorption: EDLUAR's sublingual formulation provides rapid absorption, which can be particularly beneficial for patients who have difficulty falling asleep. This convenience can be a significant selling point in a market where patient compliance is crucial[4].

• Efficacy and Safety Profile: EDLUAR combines the well-established efficacy and safety profile of zolpidem tartrate with a new formulation. This can reassure both patients and healthcare providers, potentially increasing its adoption rate[4].

Financial Trajectory

Revenue Potential

While specific financial projections for EDLUAR are not provided, its revenue potential can be inferred from the broader market trends and the performance of similar drugs.

• Market Share: Given the dominance of the US market in insomnia treatments, with 81.3% of the 7MM sales in 2022, EDLUAR's commercial success is likely to be heavily influenced by its performance in the US[1].

• Pricing and Competition: The pricing strategy for EDLUAR will need to be competitive with existing treatments. However, the convenience and rapid absorption of its sublingual formulation could justify a premium price, potentially impacting its revenue positively.

Challenges and Opportunities

• Generic Competition: The insomnia market may face challenges from generic versions of existing drugs. For example, Belsomra is set to lose market exclusivity in the US in 2029 and Japan in 2031, which could lead to sales erosion for branded products. However, EDLUAR's unique formulation might help it maintain market share despite generic competition[1].

• Pipeline Products: The introduction of new pipeline products, such as Vanda Pharmaceuticals’ Hetlioz and Imbrium Therapeutics’ sunobinop, will also impact the market dynamics. EDLUAR will need to differentiate itself to maintain a competitive edge[1].

Regulatory and Market Exclusivity

EDLUAR, being a formulation of an existing drug (zolpidem tartrate), benefits from the established regulatory approval of its active ingredient. However, it must navigate the regulatory landscape to ensure continued market exclusivity for its specific formulation.

Patient and Prescriber Adoption

• Patient Compliance: The convenience of the sublingual formulation can improve patient compliance, which is a critical factor in the long-term success of any pharmaceutical product.

• Prescriber Confidence: The established efficacy and safety profile of zolpidem tartrate, combined with the new formulation, can enhance prescriber confidence in EDLUAR.

Financial Performance of Similar Drugs

To gauge the potential financial performance of EDLUAR, we can look at the financial results of other pharmaceutical companies in the insomnia market. For instance, Idorsia’s Quviviq generated CHF 39 million in sales in the first nine months of 2024, indicating a strong market demand for innovative insomnia treatments[2].

Key Takeaways

• Market Growth: The insomnia market is expected to grow at a CAGR of 2.6% to 2032, driven by DORAs and new pipeline products.
• Unique Formulation: EDLUAR's sublingual formulation offers rapid absorption and convenience, which can be significant selling points.
• Competitive Landscape: EDLUAR competes with traditional hypnotics and newer DORAs, requiring a strong differentiation strategy.
• Financial Potential: The revenue potential of EDLUAR is influenced by its performance in the US market and its ability to maintain market share against generic competition.

FAQs

Q: What is EDLUAR used for? A: EDLUAR is used for the short-term treatment of insomnia characterized by difficulties with falling asleep.

Q: What makes EDLUAR unique? A: EDLUAR is the first available under-the-tongue (sublingual) formulation of zolpidem tartrate, offering rapid absorption and convenience.

Q: How does EDLUAR fit into the broader insomnia market? A: EDLUAR enters a market dominated by traditional hypnotics and newer DORAs, with the US being the largest market segment.

Q: What are the financial challenges for EDLUAR? A: EDLUAR faces challenges from generic competition and the introduction of new pipeline products, requiring a competitive pricing and differentiation strategy.

Q: How does the regulatory landscape impact EDLUAR? A: EDLUAR benefits from the established regulatory approval of zolpidem tartrate but must ensure continued market exclusivity for its specific formulation.

Sources

1. GlobalData, "Dual orexin receptor antagonists to drive insomnia market across 7MM", Clinical Trials Arena, December 19, 2023.
2. Idorsia, "Idorsia announces financial results for the first nine months of 2024", BioSpace, October 29, 2024.
3. JAMA Network, "Sales Income and R&D Costs for FDA-Approved Cancer Drugs Sold in the United States", JAMA Network Open, January 4, 2019.
4. Sleep Review Magazine, "Insomnia Drug Now Available in Under-The-Tongue Formulation", Sleep Review Magazine.
5. Intra-Cellular Therapies, "Intra-Cellular Therapies Reports Fourth Quarter And Full-Year 2023 Financial Results", Intra-Cellular Therapies, February 22, 2024.