ZOLPIDEM TARTRATE - Generic Drug Details

What are the generic drug sources for zolpidem tartrate and what is the scope of patent protection?

Zolpidem tartrate is the generic ingredient in seven branded drugs marketed by Almatica, Aytu, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Endo Operations, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Biovail Labs Intl, Acme Labs, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys, Norvium Bioscience, and Novel Labs Inc, and is included in forty-two NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has one hundred and forty-one patent family members in twenty-three countries.

There are thirty-two drug master file entries for zolpidem tartrate. Forty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ZOLPIDEM TARTRATE

International Patents:	141
US Patents:	7
Tradenames:	7
Applicants:	36
NDAs:	42
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	24
Patent Applications:	1,068
Drug Prices:	Drug price trends for ZOLPIDEM TARTRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOLPIDEM TARTRATE
What excipients (inactive ingredients) are in ZOLPIDEM TARTRATE?	ZOLPIDEM TARTRATE excipients list
DailyMed Link:	ZOLPIDEM TARTRATE at DailyMed

See drug prices for ZOLPIDEM TARTRATE

See drug sales revenues for ZOLPIDEM TARTRATE

Recent Clinical Trials for ZOLPIDEM TARTRATE

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

Sponsor	Phase
National Institute on Aging (NIA)	Phase 4
University of Pennsylvania	Phase 4
National Institutes of Health (NIH)	Phase 4

See all ZOLPIDEM TARTRATE clinical trials

Generic filers with tentative approvals for ZOLPIDEM TARTRATE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET;ORAL
		5MG	TABLET;ORAL
		5MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ZOLPIDEM TARTRATE

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

Anatomical Therapeutic Chemical (ATC) Classes for ZOLPIDEM TARTRATE

N05CF	Benzodiazepine related drugs
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ZOLPIDEM TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTERMEZZO	Sublingual Tablets	zolpidem tartrate	1.75 mg and 3.5 mg	022328	1	2012-04-10
EDLUAR	Sublingual Tablets	zolpidem tartrate	5 mg and 10 mg	021997	1	2010-04-29
AMBIEN CR	Extended-release Tablets	zolpidem tartrate	6.25 mg	021774	1	2006-02-24
AMBIEN CR	Extended-release Tablets	zolpidem tartrate	12.5 mg	021774	1	2006-01-19

US Patents and Regulatory Information for ZOLPIDEM TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	078970-001	Sep 11, 2013	AB	RX	No	No
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	AB	RX	Yes	Yes	9,265,720
Wockhardt	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	078426-001	May 15, 2007		DISCN	No	No
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	AB	RX	Yes	No	9,265,720
Endo Operations	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	078148-001	Dec 3, 2010		DISCN	No	No
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	AB	RX	Yes	Yes

Expired US Patents for ZOLPIDEM TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	6,514,531*PED
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	8,512,747
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008	7,632,517
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992	4,382,938*PED
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-001	Dec 16, 1992	4,382,938*PED
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	4,382,938*PED

International Patents for ZOLPIDEM TARTRATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	539280	Spray for transmucosal administration of pharmaceuticals for muscular and skeletal disorders
South Korea	20130006523	COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF
European Patent Office	2277506	Spray buccal non polaire d'un sédatif (Non-polar buccal spray of a sedative)
European Patent Office	1545458	CAPSULE OU VAPORISATEUR BUCCAL, POLAIRE ET NON POLAIRE, CONTENANT DES MEDICAMENTS POUR LE TRAITEMENT D'UNE MALADIE INFECTIEUSE OU D'UN CANCER (BUCCAL, POLAR OR NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FOR TREATING AN INFECTIOUS DISEASE OR CANCER)
Canada	2497262	CAPSULE OU PULVERISATEUR BUCCAL POLAIRE ET NON POLAIRE CONTENANT DES MEDICAMENTS POUR TRAITER DES TROUBLES DU SYSTEME NERVEUX CENTRAL (BUCCAL POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGSFOR TREATING DISORDERS OF THE CENTRAL NERVOUS SYSTEM)
Canada	2496769	VAPORISATION BUCCALE, POLAIRE ET NON POLAIRE OU CAPSULE CONTENANT DES MEDICAMENTS POUR MALADIES CARDIO-VASCULAIRES OU RENALES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING CARDIOVASCULAR OR RENAL DRUGS)

Supplementary Protection Certificates for ZOLPIDEM TARTRATE

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

ZOLPIDEM TARTRATE Market Analysis and Financial Projection Experimental

Zolpidem Tartrate Market Dynamics and Financial Trajectory

Overview of Zolpidem Tartrate

Zolpidem tartrate, commonly known by the brand name Ambien, is a sedative-hypnotic drug used primarily for the short-term treatment of insomnia characterized by difficulties with sleep initiation and maintenance. It belongs to the class of nonbenzodiazepines, which have similar effects to benzodiazepines but with fewer side effects and a lower potential for abuse[2][3].

Market Size and Growth Projections

The global zolpidem tartrate market is experiencing significant growth driven by several key factors. As of 2023, the market size was valued at approximately 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].

Another report estimates the global zolpidem tartrate market to reach USD 968.6 million by 2031, expanding at a CAGR of 3.2% during the forecast period from 2023 to 2031[3].

Market Drivers

Increasing Prevalence of Insomnia

The rising prevalence of insomnia and other sleep disorders globally is a major driver of the zolpidem tartrate market. Insomnia affects approximately 30% of the general population, with higher prevalence rates observed in older adults and women[3].

Aging Population

The aging population is another significant driver. Older adults are more prone to sleep disorders, and the number of people aged 60 years and above is projected to more than double by 2050, according to the World Health Organization (WHO)[3].

Advances in Formulations

Improvements in patient compliance and efficacy brought about by extended-release and sublingual tablet formulations are also driving the market. These advancements in pharmaceutical science have enhanced therapeutic outcomes and patient adherence[1].

Growing Healthcare Infrastructure and Spending

The global expansion of healthcare infrastructure and increasing healthcare spending, particularly in emerging economies like India and China, are further fueling the demand for zolpidem tartrate. High disposable incomes in these regions are leading to increased healthcare expenditures[1][3].

COVID-19 Impact

The COVID-19 pandemic has positively impacted the market by increasing the demand for sleep aids, including zolpidem tartrate. The pandemic has led to higher levels of stress, anxiety, and disrupted sleep patterns, resulting in a surge in sales of zolpidem tartrate products[3].

Market Segmentation

The zolpidem tartrate market is segmented based on several factors:

Application

• Tablets
• Sublingual Tablets
• Oral Sprays
• Extended-Release Tablets
• Film-Coated Tablets[1]

Product

• Insomnia
• Sleep Maintenance
• Sleep Initiation
• Short-term Treatment
• Chronic Insomnia[1]

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1]

Regional Analysis

North America

North America is expected to maintain its dominance in the global market due to the high prevalence of insomnia and sleep disorders in this region. Well-established healthcare infrastructure and high healthcare expenditure in countries like the US and Canada have facilitated the adoption of advanced treatments for sleep disorders[3].

Europe

The market in Europe is expected to grow rapidly due to the increasing prevalence of insomnia and sleep disorders. Approximately 40% of the European population suffers from sleep disorders, with insomnia being the most common[3].

Asia-Pacific

The rising disposable income in emerging economies such as India and China is leading to an increase in healthcare spending, which is driving the demand for zolpidem tartrate in the Asia-Pacific region[3].

Competitive Landscape

The market is competitive, with major manufacturers including Sanofi, Merit Pharmaceutical, Par Pharmaceutical, Teva Pharmaceuticals USA, Inc., and Astellas Pharma US, Inc. These companies are focusing on developing new formulations and expanding their market presence through strategic initiatives[3].

Market Dynamics Analysis

Porter’s Five Forces Analysis

The market dynamics are influenced by several forces:

• Buyers' Bargaining Power: High due to the availability of various treatment options.
• Suppliers' Bargaining Power: Moderate, as suppliers have some leverage but are also dependent on the pharmaceutical companies.
• Threat of New Entrants: Low to moderate, as entering the market requires significant investment in research and development.
• Threat of Substitutes: Moderate, as there are other sleep aid medications available.
• Degree of Competition: High, due to the presence of multiple players in the market[1].

Challenges and Restraints

Abuse and Dependence

Zolpidem tartrate, while effective, carries the risk of abuse and dependence. Regular use can result in the development of physiologic dependence and may lead to withdrawal syndrome in the absence of the drug. This has led to concerns and regulatory scrutiny[5].

Side Effects

The drug can cause several side effects, including headache, sleepiness, and dizziness. In cases of abuse, users may experience tolerance, dependence, and a range of psychological symptoms[5].

Key Benefits for Industry Participants & Stakeholders

• In-depth Analysis: Comprehensive market analysis providing historical, current, and projected market sizes.
• Segment Analysis: Detailed analysis of potential and niche segments and regions exhibiting promising growth.
• Industry Trends: Coverage of recent industry trends and developments.
• Competitor Analysis: Analysis of major manufacturers and their market positioning[3][4].

COVID-19 Impact on the Market

The COVID-19 pandemic has had a positive impact on the zolpidem tartrate market. The increased stress, anxiety, and disrupted sleep patterns during the pandemic have led to a surge in demand for sleep aids, including zolpidem tartrate[3].

Financial Trajectory

The financial trajectory of the zolpidem tartrate market is robust, driven by increasing demand and favorable market conditions. Here are some key financial highlights:

• Market Size: Expected to reach USD 9.58 billion by 2031 from USD 1 billion in 2023[1].
• CAGR: Projected to grow at a CAGR of 8.2% from 2024 to 2031[1].
• Revenue Share: North America is expected to maintain its dominance in the global market, while Europe and Asia-Pacific are expected to grow rapidly[3].

Key Takeaways

• The zolpidem tartrate market is driven by the increasing prevalence of insomnia, an aging population, and advances in pharmaceutical formulations.
• The market is segmented by application, product, and geographical regions.
• North America, Europe, and Asia-Pacific are key regions driving market growth.
• Major manufacturers include Sanofi, Merit Pharmaceutical, and Teva Pharmaceuticals USA, Inc.
• The market faces challenges related to abuse and dependence but is expected to grow significantly due to favorable market conditions.

FAQs

What is the primary use of zolpidem tartrate?

Zolpidem tartrate is primarily used for the short-term treatment of insomnia characterized by difficulties with sleep initiation and maintenance[2].

What are the key drivers of the zolpidem tartrate market?

The key drivers include the increasing prevalence of insomnia, an aging population, advances in pharmaceutical formulations, and growing healthcare infrastructure and spending[1][3].

What are the potential risks associated with zolpidem tartrate?

Potential risks include abuse, dependence, and side effects such as headache, sleepiness, and dizziness. Regular use can result in physiologic dependence and withdrawal syndrome[5].

Which regions are expected to drive the growth of the zolpidem tartrate market?

North America, Europe, and Asia-Pacific are expected to drive the growth of the zolpidem tartrate market due to high prevalence rates of insomnia and well-established healthcare infrastructure[3].

What is the projected market size of zolpidem tartrate by 2031?

The market is projected to reach USD 9.58 billion by 2031, growing at a CAGR of 8.2% from 2024 to 2031[1].

How has the COVID-19 pandemic impacted the zolpidem tartrate market?

The COVID-19 pandemic has positively impacted the market by increasing the demand for sleep aids due to higher levels of stress, anxiety, and disrupted sleep patterns[3].

Sources

1. Market Research Intellect: Zolpidem Tartrate Market Size, Share | Industry Research Report 2031.
2. Synapse: Zolpidem Tartrate - Drug Targets, Indications, Patents.
3. Growth Market Reports: Zolpidem Tartrate Market Size, Share & Trends Growth [2031].
4. Cognitive Market Research: Zolpidem Tartrate Market Report 2024 (Global Edition).
5. Drug Abuse: Zolpidem Abuse Symptoms, Side Effects, and Treatment Programs.