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Last Updated: April 23, 2025

Zolpidem tartrate - Generic Drug Details


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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, Cosette, 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, Viatris, 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.

Drug Prices for zolpidem tartrate

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Drug Sales Revenue Trends for zolpidem tartrate

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Recent Clinical Trials for zolpidem tartrate

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

SponsorPhase
National Institutes of Health (NIH)Phase 4
National Institute on Aging (NIA)Phase 4
University of PennsylvaniaPhase 4

See all zolpidem tartrate clinical trials

Generic filers with tentative approvals for ZOLPIDEM TARTRATE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free10MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free5MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free10MGTABLET;ORAL

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

Anatomical Therapeutic Chemical (ATC) Classes for zolpidem tartrate
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-001 Nov 23, 2011 DISCN Yes No 7,682,628 ⤷  Try for Free ⤷  Try for Free
Rising ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 076578-001 Apr 23, 2007 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Acme Labs ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077214-001 Apr 23, 2007 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Expired US Patents for zolpidem tartrate

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Cosette AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992 4,382,938*PED ⤷  Try for Free
Viatris EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 8,512,747 ⤷  Try for Free
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 7,682,628 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

International Patents for zolpidem tartrate

CountryPatent NumberTitleEstimated Expiration
Canada 2581996 PULVERISATION BUCCALE, POLAIRE ET NON POLAIRE CONTENANT DE L'ALPRAZOLAM (BUCCAL, POLAR AND NON-POLAR SPRAY CONTAINING ALPRAZOLAM) ⤷  Try for Free
New Zealand 539280 Spray for transmucosal administration of pharmaceuticals for muscular and skeletal disorders ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2004019910 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 3 of 3 entries

Supplementary Protection Certificates for zolpidem tartrate

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2236132 300714 Netherlands ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 CA 2015 00004 Denmark ⤷  Try for Free 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
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries

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.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.