SERAX Drug Patent Profile

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

Serax is a drug marketed by Alpharma Us Pharms and is included in one NDA.

The generic ingredient in SERAX is oxazepam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Serax

A generic version of SERAX was approved as oxazepam by TRUPHARMA on August 10^th, 1987.

Summary for SERAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Patent Applications:	5,509
DailyMed Link:	SERAX at DailyMed

US Patents and Regulatory Information for SERAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Alpharma Us Pharms	SERAX	oxazepam	TABLET;ORAL	015539-008	Approved Prior to Jan 1, 1982		DISCN	No	No
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for SERAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-002	Approved Prior to Jan 1, 1982	4,620,974
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-006	Approved Prior to Jan 1, 1982	4,620,974
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-004	Approved Prior to Jan 1, 1982	4,620,974

International Patents for SERAX

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

Country	Patent Number	Title	Estimated Expiration
Germany	3424975
South Africa	8405180
France	2548539	COMPOSITION PHARMACEUTIQUE CONTENANT UN LUBRIFIANT LIQUIDE ET PROCEDE POUR AMELIORER LA DISSOLUTION DE CAPSULES EN GELATINE DURE OU DE COMPRIMES CONTENANT DES FORMULES THERAPEUTIQUES ET UN LUBRIFIANT
Australia	3035684
United Kingdom	2142824	PHARMACEUTICAL COMPOSITION CONTAINING A LIQUID LUBRICANT

SERAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Serax (Oxazepam)

Introduction to Serax (Oxazepam)

Serax, with the generic name oxazepam, is a benzodiazepine that has been on the market since the 1960s. It is primarily used to treat anxiety, insomnia, and symptoms associated with alcohol withdrawal[3][5].

Market Size and Growth of Benzodiazepine Drugs

The benzodiazepine drugs market, which includes Serax, has been experiencing significant growth. In 2023, the global benzodiazepine drugs market size was valued at approximately $3.31 billion and is projected to grow to $3.53 billion in 2024, with a compound annual growth rate (CAGR) of 6.6%. By 2028, the market is expected to reach $4.59 billion, growing at a CAGR of 6.8%[1].

Segmentation of the Benzodiazepine Market

The benzodiazepine market is segmented by product, route of administration, application, and end user.

By Product

Serax (oxazepam) is one of the key products in this market, alongside other benzodiazepines such as alprazolam, diazepam, lorazepam, and clonazepam[1].

By Route of Administration

The oral route of administration holds the highest market share, which is relevant for Serax as it is commonly administered orally[1][4].

By Application

Serax is used for treating anxiety disorders, insomnia, and alcohol withdrawal symptoms. The anxiety segment is a significant driver of the market, expected to reach $1.45 billion by 2032[4].

By End User

The market is segmented into hospitals, homecare, specialty clinics, and other end users. Hospital pharmacies are a major distribution channel, expected to be valued at $2.1 billion by 2032[4].

Regional Market Dynamics

North America was the largest region in the benzodiazepine drugs market in 2023, holding a market share of 41.8%. However, the Asia-Pacific region is expected to be the fastest-growing region in the forecast period[1][4].

Key Drivers of Market Growth

• Increasing Prevalence of Anxiety Disorders: The rising incidence of anxiety disorders worldwide is a significant driver. For instance, an estimated 31.1% of U.S. adults experience some form of anxiety disorder at some time in their lives[4].
• Growing Mental Health Awareness: Increased awareness and acceptance of pharmacological interventions for mental health conditions contribute to market growth[4].
• Favorable Reimbursement Policies: Positive reimbursement policies have also contributed to the growth in the historic period[1].

Challenges and Pitfalls

• Dependence and Misuse: Benzodiazepines, including Serax, carry risks of dependence and misuse. Concomitant use with opioids can result in severe adverse effects such as respiratory depression, coma, and death[3][5].
• Regulatory Scrutiny: There is a heightened focus on reducing dependency and abuse potential, which can impact market dynamics[1].

Competitive Landscape

The benzodiazepine drugs market is characterized by the presence of established pharmaceutical companies such as Novartis AG, GlaxoSmithKline plc, Pfizer Inc., and Roche. These companies adopt various strategic initiatives like collaborations, global expansion, research and development, and product diversification to maintain their market share[4].

Product-Specific Dynamics for Serax

• Usage and Dosage: Serax is available in capsule strengths of 10 mg, 15 mg, and 30 mg. It is particularly suited for treating mild to moderate anxiety and insomnia due to its slow onset of action[3][5].
• Side Effects and Misuse: While Serax has a lower risk of misuse compared to other benzodiazepines due to its slow onset, it still carries risks of physical reliance and psychological disease. Side effects include dizziness, drowsiness, memory impairment, and headache[3].

Financial Trajectory

Given the overall growth of the benzodiazepine market, Serax is likely to benefit from the increasing demand for benzodiazepine treatments. Here are some key financial projections:

• Market Size: The global benzodiazepine market is expected to grow from $3.31 billion in 2023 to $4.59 billion by 2028[1].
• Segment Growth: The anxiety segment, which is a primary application for Serax, is expected to reach $1.45 billion by 2032[4].

Innovations and Trends

• Combination Therapies: There is a rising trend towards combination therapies with benzodiazepines, which could impact the usage and market share of Serax[1].
• New Formulations: The development of sublingual and transdermal benzodiazepine formulations could offer new opportunities for Serax and similar drugs[1].

Regulatory and Safety Considerations

• Warning Labels: The use of benzodiazepines, including Serax, comes with warnings about the risks of concomitant use with opioids and the potential for abuse, misuse, and dependence[5].
• Regulatory Compliance: Companies in the benzodiazepine market, including those producing Serax, must comply with stringent regulatory requirements to ensure safety and efficacy[1].

Key Takeaways

• The benzodiazepine market, including Serax, is experiencing strong growth driven by increasing anxiety disorders and favorable reimbursement policies.
• The market is segmented by product, route of administration, application, and end user, with oral administration and anxiety treatment being key segments.
• North America is the largest market, but the Asia-Pacific region is expected to grow rapidly.
• Challenges include dependence and misuse risks, and regulatory scrutiny.
• The competitive landscape is dominated by established pharmaceutical companies adopting various strategic initiatives.

FAQs

Q: What are the primary uses of Serax (oxazepam)? A: Serax is primarily used to treat anxiety, insomnia, and symptoms associated with alcohol withdrawal[3][5].

Q: What is the projected growth rate of the benzodiazepine drugs market? A: The benzodiazepine drugs market is expected to grow at a CAGR of 6.8% from 2023 to 2028[1].

Q: Which region is expected to be the fastest-growing in the benzodiazepine market? A: The Asia-Pacific region is expected to be the fastest-growing region in the forecast period[1][4].

Q: What are the risks associated with the use of Serax and other benzodiazepines? A: Risks include dependence, misuse, and severe adverse effects when used concomitantly with opioids[3][5].

Q: How does the competitive landscape of the benzodiazepine market look? A: The market is characterized by established pharmaceutical companies like Novartis AG, GlaxoSmithKline plc, Pfizer Inc., and Roche, which adopt various strategic initiatives to maintain their market share[4].

Sources

1. The Business Research Company: Global Benzodiazepine Drugs Market Report 2024
2. BJGP: A 5-year follow-up study of users of benzodiazepine
3. The Recovery Village: Signs, Symptoms & Side Effects of Serax Abuse
4. GMI Insights: Benzodiazepine Drugs Market Size & Share | Growth Forecasts 2032
5. Drugs.com: Serax Advanced Patient Information