AMBIEN Drug Patent Profile

When do Ambien patents expire, and what generic alternatives are available?

Ambien is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in AMBIEN 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

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

Summary for AMBIEN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	49
Drug Prices:	Drug price information for AMBIEN
Drug Sales Revenues:	Drug sales revenues for AMBIEN
What excipients (inactive ingredients) are in AMBIEN?	AMBIEN excipients list
DailyMed Link:	AMBIEN at DailyMed

See drug prices for AMBIEN

See drug sales revenues for AMBIEN

Recent Clinical Trials for AMBIEN

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 2
University of Arizona	Phase 4
University of Virginia	Phase 4

See all AMBIEN clinical trials

Pharmacology for AMBIEN

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

US Patents and Regulatory Information for AMBIEN

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	zolpidem tartrate	TABLET;ORAL	019908-001	Dec 16, 1992	AB	RX	Yes	No
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	AB	RX	Yes	Yes
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992	AB	RX	Yes	Yes
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-002	Sep 2, 2005	AB	RX	Yes	No

Expired US Patents for AMBIEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-001	Dec 16, 1992
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992

International Patents for AMBIEN

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

Country	Patent Number	Title	Estimated Expiration
Finland	813288
Canada	1157470	DERIVES DE L'IMIDAZO[1,2,A]PYRIDINE UTILES EN MEDECINE ET PROCEDE DE PREPARATION (IMIDAZO[1,2,A]PYRIDINE DERIVATIVES USEFUL IN THERAPY AND THEIR PREPARATIONS)
Israel	64091
Finland	71143

Supplementary Protection Certificates for AMBIEN

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

AMBIEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ambien

Introduction

Ambien, known generically as zolpidem tartrate, is a widely used sleep aid that has been a significant player in the pharmaceutical market for several decades. This article delves into the market dynamics and financial trajectory of Ambien, including its sales performance, competitive landscape, and recent developments.

Historical Sales Performance

Historically, Ambien has been a strong performer in the pharmaceutical market. In the early 2000s, it saw substantial growth, with a 49.3% year-on-year increase in quarterly sales to 606 million euros in the first quarter of 2007[2].

Impact of Generic Competition

However, the introduction of generic versions has significantly impacted Ambien's sales. After the U.S. FDA approved generic versions of Ambien Immediate Release (IR), the drug faced increased competition. This led to a decline in sales as generic alternatives became more widely available and affordable[2].

Recent Sales Data

As of April 2024, the U.S. annual sales for Ambien and Ambien CR were $39 million, according to IQVIA®. This figure indicates a substantial decline from its peak in the early 2000s but still reflects a steady demand for the drug[1][5].

Acquisition by Cosette Pharmaceuticals

In a significant development, Cosette Pharmaceuticals acquired Ambien and Ambien CR from Sanofi US in July 2024. This acquisition is part of Cosette's strategy to expand its portfolio and ensure the continued availability of critical medicines. Cosette's expertise in executing complex carve-outs and integrating diverse products is expected to maintain seamless supply and support for patients[1][5].

Market Dynamics

Strategic Delay in Reformulation

The introduction of Ambien CR, a reformulated version of the original drug, was strategically delayed until just before the patent expiration of the original Ambien. This strategy allowed pharmaceutical firms to maximize revenue while competing with generic versions. The delay also improved drug efficacy and dosing convenience, potentially increasing consumer surplus[4].

Competitive Landscape

Ambien operates in a competitive market where generic competition is a major factor. The drug's sales have been affected by the availability of cheaper generic alternatives. However, the brand's reputation and the specific formulation of Ambien CR continue to attract patients who prefer the branded version[2][4].

Financial Trajectory

Revenue Impact

The financial trajectory of Ambien has been influenced by the rise of generic competition. Despite this, the drug continues to generate significant revenue. The $39 million in annual U.S. sales as of April 2024 is a testament to its enduring market presence[1][5].

Operating Profit and Financial Guidance

Sanofi-Aventis, the previous owner of Ambien, experienced fluctuations in operating profit due to exchange rates and generic competition. However, the company managed to maintain a positive financial outlook, with operating profit growing 12.4% year-on-year in the first quarter of 2007. The acquisition by Cosette Pharmaceuticals is expected to stabilize and potentially grow the financial performance of Ambien through efficient integration and continued market presence[2].

Risks and Challenges

Overdose and Misuse Risks

Ambien poses significant risks when taken in excessive amounts or misused. The FDA has issued black box warnings due to reports of serious injuries and deaths resulting from complex sleep behaviors. These risks necessitate careful monitoring and patient education[3][4].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of Ambien. FDA approvals and warnings can significantly impact sales and market perception. The black box warnings, for instance, highlight the need for careful prescribing and patient monitoring[4].

Future Outlook

Continued Market Presence

Despite the challenges posed by generic competition, Ambien is expected to maintain a presence in the market. Cosette Pharmaceuticals' acquisition ensures that the drug will continue to be available to patients, supported by a company with a history of successfully integrating and managing diverse pharmaceutical products[1][5].

Potential Repurposing

Research has indicated that zolpidem and its structural analogs possess antituberculosis activity, opening new avenues for drug repurposing. This potential could add a new dimension to Ambien's market dynamics and financial trajectory in the future[4].

Key Takeaways

• Historical Sales Performance: Ambien saw significant growth in the early 2000s but declined with the introduction of generic versions.
• Recent Sales Data: U.S. annual sales for Ambien and Ambien CR were $39 million as of April 2024.
• Acquisition by Cosette Pharmaceuticals: Ensures continued supply and support for patients.
• Market Dynamics: Strategic delay in reformulation and competitive landscape influenced by generic competition.
• Financial Trajectory: Revenue impacted by generic competition but stabilized through efficient integration.
• Risks and Challenges: Overdose and misuse risks, regulatory environment, and FDA warnings.
• Future Outlook: Continued market presence and potential repurposing as an antituberculosis agent.

FAQs

What is the current market status of Ambien?

Ambien continues to be sold in the U.S. market, with annual sales of $39 million as of April 2024, following its acquisition by Cosette Pharmaceuticals from Sanofi US[1][5].

How has generic competition affected Ambien's sales?

Generic competition has significantly reduced Ambien's sales since the introduction of generic versions. However, the branded version still maintains a market presence due to its specific formulation and brand reputation[2][4].

What are the risks associated with Ambien use?

Ambien poses risks of overdose, misuse, and serious adverse effects such as complex sleep behaviors. These risks necessitate careful monitoring and patient education[3][4].

What is the significance of the acquisition by Cosette Pharmaceuticals?

The acquisition ensures the continued availability of Ambien and Ambien CR, leveraging Cosette's expertise in executing complex carve-outs and integrating diverse products seamlessly[1][5].

Does Ambien have potential beyond its use as a sleep aid?

Yes, research has indicated that zolpidem and its structural analogs possess antituberculosis activity, suggesting potential for repurposing as an antituberculosis agent[4].

Sources

1. Cosette Pharmaceuticals Acquires Ambien® and Ambien CR® (Zolpidem Tartrate) Tabs from Sanofi US in the US Market - BioSpace
2. Brighter Outlook Predicted as Sanofi-Aventis's Q1 Sales Start to Rebound - S&P Global
3. Snorting Ambien Dangers, Side Effects, Overdose, & Treatment - DrugAbuse.com
4. Ambien Drug - Consensus Academic Search Engine
5. Cosette Pharmaceuticals Acquires Ambien® and Ambien CR® (Zolpidem Tartrate) Tabs from Sanofi US in the US Market - Business Wire