SERZONE Drug Patent Profile

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

Serzone is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in SERZONE is nefazodone hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nefazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Serzone

A generic version of SERZONE was approved as nefazodone hydrochloride by TEVA on September 16^th, 2003.

Summary for SERZONE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	1
Patent Applications:	1,251
DailyMed Link:	SERZONE at DailyMed

Recent Clinical Trials for SERZONE

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

Sponsor	Phase
Boston Medical Center	Phase 2
Boston University	Phase 2

See all SERZONE clinical trials

US Patents and Regulatory Information for SERZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-001	Dec 22, 1994		DISCN	Yes	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-002	Dec 22, 1994		DISCN	Yes	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-003	Dec 22, 1994		DISCN	Yes	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-004	Dec 22, 1994		DISCN	Yes	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-005	Dec 22, 1994		DISCN	Yes	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-006	Dec 22, 1994		DISCN	Yes	No

Expired US Patents for SERZONE

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	4,338,317*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-001	Dec 22, 1994	4,338,317*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-003	Dec 22, 1994	4,338,317*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-006	Dec 22, 1994	4,338,317*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-004	Dec 22, 1994	5,256,664*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-003	Dec 22, 1994	5,256,664*PED

International Patents for SERZONE

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

Country	Patent Number	Title	Estimated Expiration
Germany	3423898
Italy	1148137	COMPOSTI DI 1,2,4, TRIAZOLONE FENOSSIALCHIL SOSTITUITI DOTATI DI ATTIVITA' ANTIDEPRESSIVA E PROCEDIMENTO PER LA LORO PREPARAZIONE
Italy	8247978
Luxembourg	85442
United Kingdom	2185021	SUBSTITUTED TRIAZOLONES
United Kingdom	8703633

Market Dynamics and Financial Trajectory for SERZONE (Nefazodone)

Introduction

SERZONE, known generically as nefazodone, is an atypical antidepressant that was once widely used for the treatment of depression. Despite its efficacy, the drug's market dynamics and financial trajectory have been significantly impacted by several critical factors, including safety concerns, regulatory actions, and market competition.

Historical Context

Nefazodone was discovered by scientists at Bristol-Myers Squibb (BMS) and was approved for marketing in the United States and Europe in 1994. It was initially marketed under the brand names Serzone in the U.S. and Dutonin in Europe[2].

Efficacy and Clinical Use

SERZONE was indicated for the treatment of depression, with its efficacy established in several controlled clinical trials. These trials demonstrated its effectiveness in reducing symptoms of major depressive disorder and in preventing relapse in patients who had responded to initial treatment[1].

Safety Concerns

One of the most significant factors affecting the market dynamics of SERZONE was the discovery of severe liver toxicity associated with its use. Reports of life-threatening hepatic failure began to emerge in the late 1990s, leading to a black box warning from the FDA in 2002. The incidence of severe liver damage was estimated to be about 1 case per 250,000 to 300,000 patient-years of treatment, resulting in several deaths and liver transplants[1][2].

Regulatory Actions

The safety concerns led to intense regulatory scrutiny. In 2003, Public Citizen filed a petition with the FDA to withdraw the marketing authorization for SERZONE, although the FDA ultimately did not comply with this request. However, the negative publicity and regulatory warnings significantly impacted the drug's sales and reputation[2].

Market Withdrawal

Due to declining sales and the availability of generic versions, BMS announced the discontinuation of SERZONE in the United States in June 2004. The drug was also withdrawn from markets in Europe, Australia, New Zealand, and Canada around the same time[2].

Financial Impact

The financial trajectory of SERZONE was marked by a sharp decline following the reports of liver toxicity. In 2002, despite the addition of a black box warning, the drug still generated $409 million in worldwide sales. However, by 2003, sales had dropped to about $100 million. The introduction of generic versions further eroded the market share of the branded product, leading to its eventual withdrawal from the market[2].

Current Availability

Although the branded version of SERZONE is no longer available, generic versions of nefazodone continue to be manufactured and sold. However, these are not as widely prescribed due to the availability of safer and more effective antidepressant options. In 2020, Teva Pharmaceuticals experienced a shortage of nefazodone due to a raw ingredient shortage, but the drug was made available again in 2021[2].

Market Competition

The antidepressant market is highly competitive, with various classes of drugs such as SSRIs, SNRIs, and atypical antidepressants vying for market share. The rise of safer and more effective treatments, along with increased awareness and reduced stigma around mental health, has driven the growth of the antidepressant market. However, SERZONE's safety issues have made it less competitive compared to other options like sertraline, which have seen sustained growth due to their safety profiles and efficacy[3][5].

Key Takeaways

• Safety Concerns: Severe liver toxicity associated with SERZONE led to significant regulatory actions and a decline in its use.
• Market Withdrawal: The drug was withdrawn from major markets due to declining sales and safety issues.
• Financial Decline: Sales dropped sharply from $409 million in 2002 to $100 million in 2003.
• Current Status: Generic versions are still available but are not widely prescribed due to safety concerns and competition from other antidepressants.

FAQs

What was the primary reason for the decline in SERZONE's market share?

The primary reason was the discovery of severe liver toxicity associated with its use, leading to regulatory warnings and a decline in prescriptions.

Is SERZONE still available in the market?

Although the branded version is no longer available, generic versions of nefazodone continue to be sold, albeit with limited prescription due to safety concerns.

What were the financial implications of the safety concerns for SERZONE?

The safety concerns led to a significant decline in sales, from $409 million in 2002 to $100 million in 2003, ultimately resulting in the drug's withdrawal from major markets.

How does SERZONE compare to other antidepressants in terms of safety?

SERZONE has a higher risk of severe liver toxicity compared to other commonly used antidepressants, making it less competitive in the market.

What regulatory actions were taken against SERZONE?

The FDA added a black box warning to the drug label in 2002, and Public Citizen filed a petition to withdraw the marketing authorization, although the FDA did not comply with this request.

Sources

1. RxList: Serzone (Nefazodone): Side Effects, Uses, Dosage, Interactions ...
2. Wikipedia: Nefazodone
3. Market.US: Antidepressant Drugs Market to Reach USD 30.5 Billion by 2033
4. ASPE: Price Trends for Prescription: Pharmaceuticals: 1995-1999
5. Market Research Intellect: Rising Demand for Sertraline: Market Dynamics, Key Players, and Future Projections