SEREVENT Drug Patent Profile

Which patents cover Serevent, and what generic alternatives are available?

Serevent is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in SEREVENT is salmeterol xinafoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the salmeterol xinafoate profile page.

Summary for SEREVENT

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	31
Patent Applications:	3,593
Drug Prices:	Drug price information for SEREVENT
What excipients (inactive ingredients) are in SEREVENT?	SEREVENT excipients list
DailyMed Link:	SEREVENT at DailyMed

See drug prices for SEREVENT

Recent Clinical Trials for SEREVENT

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

Sponsor	Phase
Università degli Studi di Ferrara	Phase 4
Pearl Therapeutics, Inc.	Phase 2
Intech Biopharm Ltd.	Phase 1

See all SEREVENT clinical trials

Pharmacology for SEREVENT

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

US Patents and Regulatory Information for SEREVENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	SEREVENT	salmeterol xinafoate	AEROSOL, METERED;INHALATION	020236-001	Feb 4, 1994		DISCN	No	No
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997		RX	Yes	Yes

Expired US Patents for SEREVENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997
Glaxosmithkline	SEREVENT	salmeterol xinafoate	AEROSOL, METERED;INHALATION	020236-001	Feb 4, 1994
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997

International Patents for SEREVENT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	78443	PROCESS FOR PREPARING PHENETHANOLAMINE DERIVATIVES
Slovakia	280968
Spain	2093812
Bulgaria	61490
Greece	79925
Netherlands	9100381
Germany	4106379	Inhalationsgerät und Medikamentenpackung hierfür

Supplementary Protection Certificates for SEREVENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0416951	C990012	Netherlands		PRODUCT NAME: SALMETEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN FLUTICASONPROPIONAAT,IN HET BIJZONDER SALMETEROLXINAFOAAT EN FLUTICASONPROPIONAAT; NATL REGISTRATION NO/DATE: RVG 23529 - RVG 23534 19990112; FIRST REGISTRATION: SE 14591 - 14596 19980907
0416951	12/1999	Austria		PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907

SEREVENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Salmeterol (SEREVENT)

Introduction

Salmeterol, marketed under the brand name SEREVENT, is a long-acting beta2-adrenergic receptor agonist (LABA) widely used for the prevention and maintenance of asthma and chronic obstructive pulmonary disease (COPD). Here, we delve into the market dynamics and financial trajectory of this crucial respiratory medication.

Market Segmentation

The global salmeterol market is segmented based on application and region. The primary applications include asthma, bronchospasm, and COPD. Geographically, the market is analyzed across North America, Europe, Asia-Pacific, and Latin America, Middle East, and Africa (LAMEA)[1].

Increasing Demand

The demand for salmeterol is driven by several key factors:

• Prevalence of Respiratory Diseases: The increasing prevalence of asthma and COPD globally is a significant driver. These conditions are exacerbated by factors such as long-term exposure to industrial dust, chemical fumes, tobacco smoking, and rising levels of environmental pollutants and airborne allergens[4].
• Long-Acting Benefits: Salmeterol's 12-hour duration of action makes it more beneficial compared to short-acting beta2-agonists like albuterol, which has a duration of only 4-6 hours[1].
• Cost-Effectiveness: The relatively low cost of salmeterol compared to other treatments also contributes to its demand.

Market Growth Drivers

Respiratory Disease Prevalence

The global rise in respiratory diseases such as asthma and COPD is a primary driver for the salmeterol market. These conditions are becoming more prevalent due to environmental factors, industrial exposures, and lifestyle choices[4].

Combination Therapies

Salmeterol is often used in combination with other medications, such as fluticasone propionate, in products like Advair Diskus, Advair HFA, and AirDuo Respiclick. These combination therapies offer reduced side effects, better compliance, and improved efficacy, further boosting the market[4].

Generic Market Expansion

The expiration of patents for branded inhalation drugs, including those containing salmeterol, is expected to increase the availability of generic versions. This trend is likely to drive growth in the inhalation and nasal spray generic drugs market, which is projected to reach $65.3 billion by 2031[4].

Market Restraints

Despite the growth drivers, there are several restraints affecting the salmeterol market:

• Side Effects: Salmeterol can cause side effects such as dizziness, sinus infections, migraine headaches, and breathing problems, which can limit its adoption[1].
• Regulatory Challenges: The pharmaceutical industry is heavily regulated, and any changes in regulatory policies or safety concerns can impact the market.

Financial Performance

Revenue and Sales

The financial performance of salmeterol is closely tied to the overall respiratory drug market. Companies like GlaxoSmithKline plc, which markets SEREVENT, have seen significant revenue from their respiratory portfolios. For instance, the global inhalation and nasal spray drugs market, which includes salmeterol, is expected to grow at a CAGR of 6.5% to reach $65.3 billion by 2031[4].

Key Market Players

Several pharmaceutical companies are key players in the salmeterol market, including Lupin Limited, GlaxoSmithKline plc, MidasCare, Redwing Pharma, Mylan N.V., Intas Pharmaceuticals Ltd., and others. These companies contribute to the market's growth through their manufacturing and distribution efforts[1].

Regional Analysis

North America and Europe

These regions currently hold the largest share of the global salmeterol market, driven by high incidence rates of asthma and COPD, along with well-established healthcare systems and public awareness programs[4].

Asia-Pacific

The Asia-Pacific region is expected to expand at the fastest rate due to a large target population, government support, and increasing incidence of respiratory diseases in emerging countries[4].

Competitive Landscape

The competitive landscape for salmeterol includes a mix of branded and generic products. The market is dominated by combination inhaler and nasal spray generic drugs, with salmeterol-fluticasone combinations being particularly popular. Companies are focusing on improving medication compliance, reducing side effects, and enhancing efficacy to maintain their market share[4].

Future Outlook

Growth Potential

The global inhalation and nasal spray drugs market, including salmeterol, has tremendous growth potential. The increasing prevalence of respiratory diseases, coupled with the availability of generic versions and combination therapies, is expected to drive market growth over the next few years[4].

Challenges and Opportunities

While side effects and regulatory challenges pose risks, the market also presents opportunities for innovation in drug delivery technologies and the development of more effective combination therapies.

Key Takeaways

• Increasing Demand: Driven by the rising prevalence of asthma and COPD.
• Long-Acting Benefits: Salmeterol's 12-hour duration of action is a significant advantage.
• Cost-Effectiveness: Relatively low cost compared to other treatments.
• Combination Therapies: Popular combinations like salmeterol-fluticasone drive market growth.
• Generic Market Expansion: Patent expirations will increase generic availability.
• Regional Growth: North America and Europe are current leaders, with Asia-Pacific showing rapid growth.

FAQs

What is the primary use of salmeterol?

Salmeterol is primarily used for the prevention and maintenance of asthma and chronic obstructive pulmonary disease (COPD).

Which regions dominate the salmeterol market?

North America and Europe currently hold the largest share of the global salmeterol market, with the Asia-Pacific region expected to grow rapidly.

What are the key drivers of the salmeterol market?

Key drivers include the increasing prevalence of respiratory diseases, the long-acting benefits of salmeterol, and the cost-effectiveness of the drug.

What are the common side effects of salmeterol?

Common side effects include dizziness, sinus infections, migraine headaches, and breathing problems.

How does the generic market impact salmeterol sales?

The expiration of patents for branded inhalation drugs is expected to increase the availability of generic versions of salmeterol, driving market growth.

Sources

1. Allied Market Research - Salmeterol Market
2. Servier - Full Year 2021/22 Results
3. JAMA Network Open - Sales Income and R&D Costs for FDA-Approved Cancer Drugs Sold
4. iHealthcareAnalyst - Global Inhalation and Nasal Spray Drugs Market