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, Cosette, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Lupin Ltd, Ph Health, Sandoz, Sun Pharm, Synthon Pharms, Biovail Labs Intl, Acme Labs, Anda Repository, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Strides Pharma Intl, 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, Novel Labs Inc, and Pharmobedient, 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-five 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:	37
NDAs:	42
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	25
Patent Applications:	138
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
The First Affiliated Hospital with Nanjing Medical University	NA
National Institute on Aging (NIA)	Phase 4
University of Pennsylvania	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
		10MG	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
Hikma	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	078129-002	Apr 30, 2008		DISCN	No	No
Actavis Labs Fl Inc	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	090153-001	Mar 25, 2013		DISCN	No	No
Ph Health	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	201509-002	Aug 1, 2016	AB	RX	No	No
Acme Labs	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	077214-001	Apr 23, 2007	AB	RX	No	No
Actavis Labs Fl Inc	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	090153-002	Mar 25, 2013		DISCN	No	No
Sandoz	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	090107-001	Jul 1, 2011	AB	RX	No	No

Expired US Patents for ZOLPIDEM TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	6,514,531*PED
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008	7,632,517
Viatris	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	8,512,747
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	7,682,628
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011	8,252,809
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-002	Nov 23, 2011	8,252,809

International Patents for ZOLPIDEM TARTRATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005032520
European Patent Office	2452675	Pulvérisation buccale contenant sildénafil (Buccal spray containing sildenafil)
World Intellectual Property Organization (WIPO)	2005032517
New Zealand	539284	Buccal, polar and non-polar spray or capsule containing drugs for treating pain
Japan	2006502150
China	100548281

Supplementary Protection Certificates for ZOLPIDEM TARTRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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	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
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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

Market Dynamics and Financial Trajectory of Zolpidem Tartrate

Last updated: January 15, 2026

Executive Summary

Zolpidem Tartrate, widely marketed under brand names like Ambien and Stilnox, is a sedative-hypnotic agent used primarily in the treatment of insomnia. Its mechanism centers on modulating gamma-aminobutyric acid (GABA) receptors to induce sleep. The drug’s market landscape is shaped by factors including rising global sleep disorder prevalence, regulatory frameworks, patent expirations, and the emergence of generic competition. This report examines these dynamics, assesses the financial trajectory, and offers strategic insights relevant to pharmaceutical stakeholders.

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What Are the Market Drivers and Restraints for Zolpidem Tartrate?

Market Drivers

Drivers	Details	Impact
Increasing Prevalence of Sleep Disorders	WHO estimates that over 30% of adults worldwide suffer from some form of insomnia (WHO, 2021).	Propels demand for hypnotics, including zolpidem.
Aging Populations	Globally aging populations are more susceptible to chronic sleep issues (UN, 2022).	Expands customer base, particularly in North America and Europe.
Prescribing Trends	Physicians favor zolpidem over older sedatives due to better safety profiles (UK NICE, 2020).	Sustains prescription volumes.
Product Line Extensions	Reformulations (e.g., extended-release) enhance treatment options (FDA, 2019).	Broadens market reach and usage duration.

Market Restraints

Restraints	Details	Impact
Regulatory Restrictions	FDA black-box warnings for potential dependence and complex sleep behaviors (FDA, 2013).	Impacts prescribing and limits use.
Side Effect Profile	Risks of dependence, amnesia, and complex behaviors reduce patient adherence.	Cap market growth in certain demographics.
Patent Expiry & Generics	Patent expiration (initially in 2014) led to increased generic availability.	Market price competition reduces margins.
Alternative Therapies	Non-pharmacologic options and newer drugs like suvorexant (EMA, 2016).	Competition erodes market share.

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Patent Landscape and Market Entry Dynamics

Patent Milestones	Year	Details
Original Patent Filing	1989	Under the brand Ambien (Sanofi-Aventis).
Patent Expiration & Generics	2014	Generics entered markets in the U.S. and Europe.
Formulation Patents & Extensions	2015–2020	Certain formulations retained patent protections.

The expiration of key patents catalyzed a wave of generic entrants, increasing affordability but decreasing revenue for original manufacturers. Patent litigations and formulation patents have subtly extended market exclusivity in certain regions.

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Financial Trajectory: Revenue, Market Shares, and Pricing Trends

Historical Revenue Trends

Year	Revenue (USD millions)	Notes
2010	$1,200	Peak pre-generic competition (Sanofi-Aventis).
2014	$600	Post-patent expiry, decline begins.
2018	$350	Increased generics penetration.
2022	$275	Continues downward trend, reflecting market saturation.

Market Share Evolution

Segment	2010	2018	2022	Status
Proprietary (Brand)	~70%	15%	5%	Declining due to patent expiry.
Generics	30%	75%	90%	Growing dominance.

Pricing Trends

Year	Average Price per Dose (USD)	Change	Comments
2010	$2.50	—	Brand dominance.
2014	$2.00	-20%	Entry of generics.
2022	$0.80	-60%	Price erosion with increased generics.

Key Financial Factors

• Cost of Goods Sold (COGS): Reduced due to manufacturing efficiencies and generic competition.
• Research and Development: Declined significantly post patent expiry, shifting focus from innovative formulations to generic manufacturing.
• Profit Margins: Narrowed, pressuring profitability, especially for original patent holders.

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Market Segmentation and Regional Variations

Region	Market Characteristics	Key Players	Market Share Trends
North America	Largest market; strict regulations; high insurance coverage	Perrigo, Mylan, Pfizer	Dominated by generics; brands hold minimal share
Europe	Similar to North America; rigid regulatory environment	Teva, Sandoz	Increasing generic penetration
Asia-Pacific	Growing sleep disorder prevalence; price-sensitive	Local manufacturers increasing presence	Transitioning from prescription to OTC in some markets

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Regulatory and Policy Impacts on the Market

Aspect	Description	Impact on Zolpidem Market
Black-Box Warnings	FDA (2013); EMA (2014)	Heightened caution reduces prescribing, especially in elderly.
Reimbursement Policies	Vary by region; favor generics	Accelerates generic uptake, reduces revenues for innovators.
Pediatric & Elderly Use Restrictions	Stringent guidelines	Limits patient pools, impacts sales.
Approval of Alternatives	Development of non-benzodiazepine hypnotics	Adds competitive pressure.

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Future Outlook and Growth Opportunities

Factor	Implication	Strategy
Development of Ultrashort-acting Formulations	Potential for niche markets	Focus on specialized insomnia cases.
Digital & Behavioral Therapies	Expand treatment paradigms	Integration with pharmacotherapy to enhance compliance.
Emerging Markets	Untapped potential	Tailored marketing strategies.
Biosimilars & Generics Innovation	Cost reduction	Invest in efficient manufacturing.

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Comparative Analysis with Competing Sleep Aids

Drug	Class	Initiation Dose	Efficacy	Safety Profile	Market Status
Zolpidem	Non-benzodiazepine (Hypnotic)	5-10 mg	High	Dependence, complex behaviors	Mature, declining
Eszopiclone	Non-benzodiazepine	1-3 mg	High	Similar dependence risk	Growing niche
Suvorexant	Orexin receptor antagonist	10-20 mg	Moderate	Fewer dependence concerns	Emerging competitor
Melatonin	Hormone analog	Variable	Moderate	Favorable	Niche, OTC

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FAQs

1. What is the projected revenue trend for Zolpidem Tartrate over the next five years?
   The market for zolpidem is expected to decline modestly at a CAGR of approximately 3–5%, driven by increasing generic competition and regulation, with revenues potentially stabilizing through niche formulations and emerging markets.

2. How do regulatory restrictions impact the commercialization of new formulations of Zolpidem?
   Stringent safety warnings and usage guidelines lead to cautious approval processes, often necessitating comprehensive safety and dependability assessments, potentially delaying market entry.

3. What regions offer the most growth potential for Zolpidem-based products?
   Emerging markets within Asia-Pacific and Latin America present significant growth opportunities owing to rising sleep disorder prevalence and lower regulatory barriers.

4. How does the patent status influence the competitive landscape?
   Patent expirations spurred a surge in generics, reducing prices and margins, but strategic formulation patents can temporarily extend exclusivity for innovators.

5. What are the main factors influencing pricing strategies for Zolpidem?
   Competition from generics, regulatory constraints, reimbursement policies, and regional market dynamics primarily shape pricing decisions.

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Key Takeaways

• The Zolpidem Tartrate market has matured, with revenues declining post-patent expiry due to intense generic competition.
• Key growth drivers include aging populations and rising diagnoses of sleep disorders, especially in developing regions.
• Regulatory policies emphasizing safety and dependence mitigation remain critical, influencing prescribing practices.
• Market consolidation is evident with dominant generic manufacturers, while innovative formulations aim to capture niche segments.
• Future growth potential hinges on developing alternative delivery systems, expanding into emerging markets, and integrating digital health strategies.

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References

[1] World Health Organization (2021). Sleep Disorders Global Statistics.
[2] United Nations (2022). Aging Populations Data.
[3] FDA (2013). Black-Box Warning for Zolpidem.
[4] EMA (2016). Surorexant Approval.
[5] UK NICE (2020). Insomnia Management Guidelines.

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This comprehensive analysis equips stakeholders with strategic insights into Zolpidem Tartrate's market dynamics and financial trajectory, facilitating informed decision-making amid evolving industry landscapes.