NEFAZODONE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for nefazodone hydrochloride and what is the scope of freedom to operate?

Nefazodone hydrochloride is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Roxane, Sun Pharm Inds Ltd, Teva, Watson Labs, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nefazodone hydrochloride. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for NEFAZODONE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	16
Patent Applications:	1,816
What excipients (inactive ingredients) are in NEFAZODONE HYDROCHLORIDE?	NEFAZODONE HYDROCHLORIDE excipients list
DailyMed Link:	NEFAZODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NEFAZODONE HYDROCHLORIDE

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

Sponsor	Phase
Instituto Nacional de Salud Publica, Mexico	Phase 3
Laboratorios Grossman, S.A.	Phase 3
Durham VA Medical Center	Phase 2

See all NEFAZODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for NEFAZODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL
		100MG	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 NEFAZODONE HYDROCHLORIDE

Drug Class

Serotonin Reuptake Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for NEFAZODONE HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for NEFAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Inc	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076309-001	Sep 16, 2003		DISCN	No	No
Chartwell Rx	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076302-005	Sep 16, 2003		DISCN	No	No
Ani Pharms	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076072-004	Sep 16, 2003		DISCN	No	No
Ivax Sub Teva Pharms	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	075763-002	Sep 16, 2003		DISCN	No	No

Expired US Patents for NEFAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-005	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-003	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-005	Dec 22, 1994
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-001	Dec 22, 1994

NEFAZODONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nefazodone Hydrochloride

Introduction

Nefazodone hydrochloride, marketed under the brand name Serzone among others, is an antidepressant that was once widely used for the treatment of major depression. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual decline.

Discovery and Initial Market Approval

Nefazodone was discovered by scientists at Bristol-Myers Squibb (BMS) as an improvement over trazodone, aiming to reduce its sedating qualities. BMS obtained marketing approvals for nefazodone worldwide, including in the United States and Europe, in 1994[2].

Early Market Performance

Upon its introduction, nefazodone showed promise as an effective antidepressant with a unique mechanism of action, enhancing serotonin synaptic transmission by acting as an antagonist at 5-HT2 receptors and inhibiting the reuptake of serotonin. It was as effective as imipramine in treating major depression and produced clinical benefits in patients with depression-related anxiety and sleep disturbances[5].

Financial Success

In its early years, nefazodone generated significant revenue for BMS. By 2002, worldwide sales of nefazodone had reached $409 million, indicating a strong market presence[2].

Safety Concerns and Regulatory Actions

However, the drug's success was marred by reports of serious liver toxicity. The first such reports emerged in 1998 and 1999, and by 2002, the U.S. Food and Drug Administration (FDA) mandated BMS to add a black box warning about potential fatal liver toxicity to the drug label. This warning highlighted the risk of severe liver damage, which occurred in approximately 1 in 250,000 to 300,000 patient-years[2].

Decline in Sales and Market Withdrawal

The safety concerns led to a significant decline in sales. In 2003, sales dropped to about $100 million, and BMS faced increasing pressure to withdraw the drug from the market. Public Citizen filed a petition with the FDA to withdraw the marketing authorization, and although the FDA did not comply, BMS decided to discontinue the sale of Serzone in the United States in June 2004 due to declining sales and the availability of generic versions[2].

Generic Versions and Continued Availability

Despite the discontinuation by BMS, generic versions of nefazodone continued to be available in the United States. As of 2023, nefazodone remains available in the U.S. in generic form from Teva Pharmaceuticals, manufactured in Israel[2].

Financial Impact of Generic Competition

The introduction of generic versions significantly impacted the financial trajectory of nefazodone. Generic competition typically lowers prices and reduces revenues for the original manufacturer. For instance, authorized generic drugs, which are generic versions of a brand-name drug manufactured by the brand-name company, can reduce retail generic prices by 4-8% and wholesale generic prices by 7-14% compared to prices without such competition[3].

Long-Term Financial Consequences

The long-term financial consequences of generic competition were substantial. The presence of authorized generics reduced the revenues of the first-filer generic manufacturer by 40-52% during the 180-day exclusivity period and continued to impact revenues even after this period. This reduction in revenue can affect the incentives for generic firms to challenge patents, especially in small markets or for products with low sales[3].

Conclusion on Market Dynamics and Financial Trajectory

Nefazodone hydrochloride's market dynamics were marked by an initial period of success followed by a sharp decline due to safety concerns and subsequent regulatory actions. The financial trajectory reflected this, with peak sales in 2002 and a significant drop thereafter. The introduction of generic versions further eroded the drug's market share and revenue.

Key Takeaways

• Initial Success: Nefazodone was approved in 1994 and showed promise as an effective antidepressant.
• Safety Concerns: Reports of liver toxicity led to a black box warning and declining sales.
• Market Withdrawal: BMS discontinued the sale of Serzone in the U.S. in 2004.
• Generic Competition: Generic versions continued to be available, significantly impacting the drug's financial trajectory.
• Long-Term Financial Impact: Generic competition reduced prices and revenues, affecting both the original manufacturer and generic firms.

FAQs

Q: What was the primary reason for the decline in nefazodone sales? A: The primary reason was the reports of serious liver toxicity, which led to a black box warning and subsequent decline in sales.

Q: Is nefazodone still available in the market? A: Yes, as of 2023, nefazodone is still available in the United States in generic form from Teva Pharmaceuticals.

Q: How did generic competition affect the financial trajectory of nefazodone? A: Generic competition significantly reduced prices and revenues, impacting both the original manufacturer and generic firms.

Q: What was the peak sales year for nefazodone? A: The peak sales year for nefazodone was 2002, with worldwide sales reaching $409 million.

Q: Why did BMS discontinue the sale of Serzone in the United States? A: BMS discontinued the sale of Serzone in the United States in June 2004 due to declining sales and the availability of generic versions.

Sources

1. DrugBank: Nefazodone: Uses, Interactions, Mechanism of Action.
2. Wikipedia: Nefazodone.
3. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.
4. PubChem: Nefazodone.
5. PubMed: Nefazodone: a new antidepressant.