AMBIEN CR Drug Patent Profile

When do Ambien Cr patents expire, and when can generic versions of Ambien Cr launch?

Ambien Cr is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in AMBIEN CR 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 Ambien Cr

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

Summary for AMBIEN CR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	49
Drug Prices:	Drug price information for AMBIEN CR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMBIEN CR
What excipients (inactive ingredients) are in AMBIEN CR?	AMBIEN CR excipients list
DailyMed Link:	AMBIEN CR at DailyMed

See drug prices for AMBIEN CR

See drug sales revenues for AMBIEN CR

Recent Clinical Trials for AMBIEN CR

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2
California Pacific Medical Center Research Institute	Phase 4
University of Arizona	Phase 4

See all AMBIEN CR clinical trials

Pharmacology for AMBIEN CR

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

Paragraph IV (Patent) Challenges for AMBIEN CR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 AMBIEN CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-002	Sep 2, 2005	AB	RX	Yes	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 AMBIEN CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-002	Sep 2, 2005	4,382,938*PED
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	6,514,531*PED
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	4,382,938*PED

International Patents for AMBIEN CR

See the table below for patents covering AMBIEN CR around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	813288
Slovenia	1135125
Norway	20012668

Supplementary Protection Certificates for AMBIEN CR

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

AMBIEN CR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AMBIEN CR

Introduction

AMBIEN CR, a controlled-release formulation of zolpidem tartrate, is a prescription sleep medication approved by the FDA for both sleep induction and maintenance. Recently, Cosette Pharmaceuticals acquired the rights to AMBIEN CR in the US market from Sanofi US, marking a significant shift in the drug's market dynamics.

Market Context

The sleep aid market is substantial, with chronic insomnia affecting approximately 30 million Americans, as reported by the Institute of Medicine Committee on Sleep Medicine and Sleep Research[4].

Acquisition by Cosette Pharmaceuticals

In July 2024, Cosette Pharmaceuticals completed the acquisition of AMBIEN and AMBIEN CR from Sanofi US. This move is part of Cosette's strategy to expand its portfolio of branded pharmaceuticals, particularly in areas such as women’s health, cardiology, and dermatology[1][2].

Financial Performance

The U.S. annual sales for AMBIEN and AMBIEN CR for the 12 months ended April 2024 were $39 million, according to IQVIA[1][2]. This figure indicates a stable revenue stream for the drug, which is expected to contribute to Cosette's growing financial trajectory.

Market Growth Projections

The overall prescription drug spending in the US is projected to rise by 10.0% to 12.0% in 2024, with clinics and hospitals anticipating an 11.0% to 13.0% increase. This growth is driven by factors such as new drug approvals, increased utilization, and price adjustments[3].

Competitive Landscape

The sleep aid market is competitive, with various prescription and over-the-counter options available. However, AMBIEN CR's unique controlled-release formulation, which helps in both sleep induction and maintenance, sets it apart. This differentiation is crucial in maintaining market share and attracting patients who require long-term sleep solutions[4].

Clinical Efficacy and Safety

Studies have shown that AMBIEN CR is well-tolerated and effective in improving sleep onset and maintenance for up to six months. It demonstrated significant improvements in total sleep time, sleep onset latency, and wake time after sleep onset compared to placebo[4].

Patient and Provider Impact

The acquisition ensures a seamless transition for patients who depend on AMBIEN CR, ensuring uninterrupted access to this critical medication. Providers can continue to prescribe the drug with confidence, given its established efficacy and safety profile[1][2].

Regulatory and Safety Considerations

AMBIEN CR is subject to various regulatory and safety guidelines. For instance, it should be used with caution in patients with sleep apnea syndrome, myasthenia gravis, or hepatic impairment. The FDA-approved labeling includes warnings about potential adverse reactions such as somnolence, anxiety, and abnormal thinking[5].

Economic Impact on Insomnia

Insomnia can have significant economic implications, including reduced productivity and increased absenteeism. Effective treatments like AMBIEN CR can mitigate these costs by improving sleep quality and reducing the need for other medical interventions[4].

Cosette Pharmaceuticals' Strategic Approach

Cosette's expertise in executing complex carve-outs and integrating diverse products is key to the successful transition of AMBIEN CR. This strategic approach ensures that the acquisition not only strengthens Cosette's portfolio but also reaffirms its commitment to providing high-quality products to patients worldwide[1][2].

Future Outlook

Given the growing demand for sleep aids and the projected increase in prescription drug spending, the financial trajectory for AMBIEN CR under Cosette Pharmaceuticals is promising. The company's ability to manage complex product transitions and its commitment to quality manufacturing will be crucial in maintaining and potentially increasing the drug's market share.

Key Takeaways

• Acquisition Impact: Cosette Pharmaceuticals' acquisition of AMBIEN CR from Sanofi US ensures continued supply and strengthens Cosette's product portfolio.
• Financial Performance: AMBIEN CR generated $39 million in U.S. annual sales for the 12 months ended April 2024.
• Market Growth: Prescription drug spending is expected to rise by 10.0% to 12.0% in 2024, driven by new drug approvals and increased utilization.
• Clinical Efficacy: AMBIEN CR is effective in improving sleep onset and maintenance with a favorable safety profile.
• Regulatory Considerations: The drug is subject to specific safety guidelines and warnings.

FAQs

Q: What is AMBIEN CR, and how does it work? A: AMBIEN CR is a controlled-release formulation of zolpidem tartrate, approved by the FDA for both sleep induction and maintenance. It works by releasing the active ingredient in two stages: the first layer dissolves quickly to induce sleep, and the second layer is released more gradually to help maintain sleep[4].

Q: Who acquired the rights to AMBIEN CR in the US market? A: Cosette Pharmaceuticals acquired the rights to AMBIEN CR from Sanofi US in July 2024[1][2].

Q: What are the annual sales figures for AMBIEN CR in the US? A: For the 12 months ended April 2024, AMBIEN CR generated $39 million in U.S. annual sales[1][2].

Q: How does AMBIEN CR compare to other sleep aids in terms of efficacy? A: AMBIEN CR has demonstrated significant improvements in total sleep time, sleep onset latency, and wake time after sleep onset compared to placebo in clinical trials[4].

Q: What are the potential side effects and safety considerations for AMBIEN CR? A: AMBIEN CR can cause side effects such as somnolence, anxiety, and abnormal thinking. It should be used with caution in patients with sleep apnea syndrome, myasthenia gravis, or hepatic impairment[5].

Cited Sources

1. Cosette Pharmaceuticals Acquires Ambien® and Ambien CR® (Zolpidem Tartrate) Tabs from Sanofi US in the US Market - BioSpace
2. Cosette Pharmaceuticals Acquires Ambien® and Ambien CR® (Zolpidem Tartrate) Tabs from Sanofi US in the US Market - Cosette Pharmaceuticals
3. National trends in prescription drug expenditures and projections for 2024 - PubMed
4. New data support long-term use of AMBIEN CR™ (zolpidem tartrate) - Sanofi US
5. FDA approved labeling text for Ambien CR - FDA