ZOLPIMIST Drug Patent Profile

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

Zolpimist is a drug marketed by Aytu and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in ZOLPIMIST 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 Zolpimist

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

Summary for ZOLPIMIST

International Patents:	86
US Patents:	1
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for ZOLPIMIST
What excipients (inactive ingredients) are in ZOLPIMIST?	ZOLPIMIST excipients list
DailyMed Link:	ZOLPIMIST at DailyMed

See drug prices for ZOLPIMIST

US Patents and Regulatory Information for ZOLPIMIST

ZOLPIMIST is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008		DISCN	Yes	No	8,236,285		Y	Y

Expired US Patents for ZOLPIMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008	7,632,517

Premature patent expiration for: ZOLPIMIST

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	ZOLPIMIST

International Patents for ZOLPIMIST

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

Country	Patent Number	Title	Estimated Expiration
Canada	2497114	CAPSULE OU VAPORISATEUR BUCCAL, POLAIRE ET NON POLAIRE, CONTENANT DES MEDICAMENTS POUR LE TRAITEMENT DE TROUBLES METABOLIQUES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FORTREATING METABOLIC DISORDERS)
South Korea	20060090997	BUCCAL, POLAR AND NON-POLAR SPRAY CONTAINING ONDANSETRON
Japan	2006506342
Japan	2007534766
Canada	2497112	VAPORISATION BUCCALE, POLAIRE ET NON POLAIRE OU CAPSULE CONTENANT DES MEDICAMENTS POUR TRAITER DES MALADIES DES VOIES GASTRO-INTESTINALES OU DES VOIES URINAIRES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING DISORDERS OF THE GASTROINTESTINAL TRACT OR URINARY TRACT)
Australia	2003270016	BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING ALLERGIES OR ASTHMA

Supplementary Protection Certificates for ZOLPIMIST

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	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
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
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718

ZOLPIMIST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZolpiMist

Introduction to ZolpiMist

ZolpiMist, a fast-acting oral spray formulation of zolpidem tartrate, is designed to treat insomnia and other sleep disorders. Developed by SUDA Ltd, this product has garnered significant attention due to its innovative delivery method and efficacy in initiating sleep quickly.

Market Size and Growth Projections

The market for zolpidem tartrate, which includes products like ZolpiMist, is experiencing robust growth. As of 2023, the zolpidem tartrate market was valued at USD 1 billion and is projected to reach USD 9.58 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the zolpidem tartrate market, including:

Rising Prevalence of Insomnia and Sleep Disorders

The increasing incidence of insomnia and other sleep-related issues globally is a significant driver. More people are seeking efficient treatment alternatives, leading to higher demand for medications like ZolpiMist[1][3].

Advancements in Pharmaceutical Formulations

Improvements in patient compliance and efficacy due to extended-release and sublingual tablet formulations are boosting the market. ZolpiMist, with its fast-acting oral spray formulation, offers a convenient and effective solution for patients[1][3].

Growing Awareness of Mental Health

Increased awareness and understanding of mental health issues have led to more prescriptions for sleep aids. This trend is expected to continue, driving the market forward[1][3].

Expansion of Healthcare Infrastructure

The global expansion of healthcare infrastructure and rising healthcare spending are making zolpidem tartrate more accessible, further driving market growth[1].

Geographical Market Segments

The market for zolpidem tartrate, including ZolpiMist, is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Key agreements and licenses have been secured in various regions:

Asia-Pacific

SUDA Ltd entered into an exclusive license agreement with Eddingpharm, a leading Chinese pharmaceutical company, for the development and commercialization of ZolpiMist in China. This deal has the potential to generate significant revenue through milestone payments and royalties[2].

Latin America

SUDA also signed a license and supply agreement with Teva Pharmaceuticals for the distribution and marketing of ZolpiMist in Brazil, Mexico, and Chile, with an option to expand to Argentina, Israel, and Australia[2].

Financial Trajectory

The financial trajectory for ZolpiMist is promising due to several key agreements and market dynamics:

License Agreements

The license agreement with Eddingpharm in China could result in an upfront payment of US$300,000 and further milestone payments of up to US$200,000. Additionally, SUDA is entitled to receive escalating tiered royalties on net sales, potentially exceeding US$26 million over 15 years[2].

Teva Pharmaceuticals Agreement

The agreement with Teva Pharmaceuticals includes an upfront payment of US$300,000 and potential further payments of up to US$1,750,000. This deal also includes commercial milestone payments and royalties, contributing significantly to the financial outlook[2].

Market Projections

Given the growing demand for zolpidem tartrate and the specific advantages of ZolpiMist, the product is expected to contribute substantially to the overall market growth. The market's projected CAGR of 8.2% from 2024 to 2031 indicates a strong financial trajectory for ZolpiMist[1].

Competitive Landscape

The competitive landscape for zolpidem tartrate includes several major pharmaceutical companies such as Sanofi, Teva Pharmaceuticals, Mylan, and others. SUDA Ltd's strategic licensing agreements and the unique formulation of ZolpiMist position it competitively in the market[1].

Regulatory Approvals and Compliance

ZolpiMist is undergoing regulatory approvals in various countries. For instance, SUDA engaged regulatory consultants to prepare the Marketing Authorisation Application for the Australian Therapeutic Goods Administration (TGA) based on the US regulatory dossier. Securing these approvals is crucial for expanding the product's market reach[2].

Consumer Trends and Preferences

Consumer trends favor products like ZolpiMist due to their convenience and efficacy. The fast-acting nature of ZolpiMist, which induces sleepiness significantly faster than traditional tablets like Ambien, is particularly appealing to patients seeking quick relief from insomnia[2][3].

Challenges and Considerations

While the market for ZolpiMist is growing, there are challenges to consider:

Potential for Misuse and Abuse

Zolpidem, despite its shorter duration of action, shares abuse-related properties with benzodiazepines. This necessitates careful monitoring of its use in clinical settings to prevent misuse[4].

Impact of Pandemics and Economic Factors

The COVID-19 pandemic has influenced the mental health of the general population, leading to increased consumption of psychotropic drugs. However, social isolation measures and delays in sales registration can impact the market temporarily[4].

Key Takeaways

• The zolpidem tartrate market, including ZolpiMist, is projected to grow significantly, driven by increasing sleep-related concerns and advancements in pharmaceutical formulations.
• Strategic licensing agreements with major pharmaceutical companies are key to the financial trajectory of ZolpiMist.
• Regulatory approvals and compliance are crucial for market expansion.
• Consumer trends favor fast-acting and convenient sleep aids like ZolpiMist.
• Monitoring for potential misuse and abuse is essential.

Frequently Asked Questions (FAQs)

Q: What is the projected market size for zolpidem tartrate by 2031? A: The zolpidem tartrate market is expected to reach USD 9.58 billion by 2031[1].

Q: Which regions are key for the distribution of ZolpiMist? A: Key regions include Asia-Pacific (China), Latin America (Brazil, Mexico, Chile), and potential expansion to Argentina, Israel, and Australia[2].

Q: What are the main drivers of the zolpidem tartrate market? A: The main drivers include the rising prevalence of insomnia, advancements in pharmaceutical formulations, growing awareness of mental health, and the expansion of healthcare infrastructure[1][3].

Q: What are the potential financial benefits from the license agreements for ZolpiMist? A: The agreements could result in upfront payments, milestone payments, and significant royalties, potentially exceeding US$26 million over 15 years[2].

Q: What are the challenges associated with the use of ZolpiMist? A: The potential for misuse and abuse, despite its shorter duration of action, is a significant challenge that requires careful monitoring[4].

Cited Sources:

1. Market Research Intellect: Zolpidem Tartrate Market Size, Share | Industry Research Report 2031
2. ASX: SUDA LTD AND CONTROLLED ENTITIES - Annual Report 2017
3. IMARC Group: Zolpidem (Ambien) Manufacturing Plant Report 2024: Cost
4. Frontiers in Pharmacology: Dispensing of zolpidem and benzodiazepines in Brazilian private pharmacies from 2014 to 2021