SEMPREX-D Drug Patent Profile

Which patents cover Semprex-d, and what generic alternatives are available?

Semprex-d is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in SEMPREX-D is acrivastine; pseudoephedrine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the acrivastine; pseudoephedrine hydrochloride profile page.

Summary for SEMPREX-D

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	1
Drug Prices:	Drug price information for SEMPREX-D
DailyMed Link:	SEMPREX-D at DailyMed

See drug prices for SEMPREX-D

US Patents and Regulatory Information for SEMPREX-D

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994		DISCN	Yes	No

Expired US Patents for SEMPREX-D

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	4,501,893
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	4,650,807

International Patents for SEMPREX-D

See the table below for patents covering SEMPREX-D around the world.

Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	235347	METHOD OF NEW AMINOCOMPOUNDS PRODUCTION
U.S.S.R.	1301312	"CПOCOБ ПOЛУЧEHИЯ ПИPИДИЛOBЫX ИЛИ ФEHИЛOBЫX COEДИHEHИЙ" (METHOD FOR PRODUCING PYRIDYL OR PHENYL COMPOUNDS)
Poland	141639
South Korea	870001918
Japan	S6333343	NOVEL INTERMEDIATE COMPOUND FOR MANUFACTURING PYRIDYL COMPOUND
Singapore	106091
South Korea	870001916

Supplementary Protection Certificates for SEMPREX-D

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0085959	SPC/GB93/019	United Kingdom		SPC/GB93/019, EXPIRES: 20030922
0085959	SPC/GB93/090	United Kingdom		SPC/GB93/090, EXPIRES: 20051230

SEMPREX-D Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SEMPREX-D

Introduction

SEMPREX-D, a combination of acrivastine and pseudoephedrine, is a medication used to treat symptoms associated with seasonal allergic rhinitis. Understanding the market dynamics and financial trajectory of this drug involves analyzing various factors, including market competition, regulatory environment, promotional strategies, and financial performance.

Market Competition

The market for allergic rhinitis treatments is highly competitive, with numerous over-the-counter (OTC) and prescription options available. SEMPREX-D competes with other antihistamine and decongestant combinations, both branded and generic. The competitive landscape is influenced by factors such as the effectiveness of the medication, side effect profiles, and pricing strategies.

Therapeutic Class Dynamics

In the therapeutic class of antihistamines and decongestants, market size can be influenced by direct-to-consumer advertising (DTCA) and physician-oriented promotions. Studies have shown that DTCA can increase the market size of an entire therapeutic class and also affect the within-class market share of advertised drugs[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. For SEMPREX-D, the FDA's guidelines and labeling requirements are critical. The FDA's labeling for SEMPREX-D includes warnings about its use in patients with diminished renal function and the potential for adverse reactions in elderly patients[5].

Labeling and Safety Information

The FDA label for SEMPREX-D highlights the need for careful dose selection and monitoring in patients with renal impairment. This regulatory oversight can impact prescribing patterns and patient safety, which in turn affect market performance.

Promotional Strategies

Promotional strategies, including DTCA and physician detailing, are essential for the success of pharmaceutical products.

Direct-to-Consumer Advertising (DTCA)

DTCA has been shown to increase both the market size of a therapeutic class and the within-class market share of advertised drugs. For SEMPREX-D, effective DTCA could enhance consumer awareness and drive demand, although it must comply with FDA guidelines[1].

Physician Detailing and Sampling

Physician detailing and sampling are other key promotional strategies. These efforts can influence prescribing decisions by providing physicians with detailed information about the drug's benefits and safety profile. The effectiveness of these strategies can vary based on the therapeutic class and the specific drug[1].

Financial Performance

The financial performance of SEMPREX-D is influenced by several factors, including sales volume, pricing, and cost savings initiatives.

Sales and Revenue

The revenue generated by SEMPREX-D depends on its market share within the therapeutic class and the overall size of the market. Effective marketing and promotional strategies can drive sales and revenue.

Cost Savings Initiatives

In healthcare systems, cost savings initiatives such as preferred drug programs can significantly impact the financial trajectory of a drug. For example, programs like the New York State Medicaid Preferred Drug Program have shown that shifting market share from more expensive non-preferred drugs to less expensive preferred drugs can result in substantial cost savings[2].

Market Share and Pricing

Market share and pricing are interrelated factors that affect the financial performance of SEMPREX-D.

Market Share

The market share of SEMPREX-D within its therapeutic class can be influenced by promotional efforts, clinical efficacy, and patient safety profile. A higher market share typically translates to higher revenue.

Pricing Strategies

Pricing strategies are critical in a competitive market. The price of SEMPREX-D must be competitive with other treatments while ensuring profitability. Pricing decisions can also be influenced by regulatory and reimbursement policies.

Case Studies and Analogies

To understand the potential financial trajectory of SEMPREX-D, we can look at analogous situations in the pharmaceutical industry.

Auxilium Pharmaceuticals Acquisition

The acquisition of Actient Holdings LLC by Auxilium Pharmaceuticals illustrates how strategic moves can enhance a company's financial trajectory. By expanding its product portfolio and leveraging a combined sales force, Auxilium aimed to achieve strong top-line growth and higher operating margins. Similar strategic moves could benefit the financial performance of SEMPREX-D[3].

Challenges and Opportunities

Side Effects and Safety Concerns

SEMPREX-D, like other medications, has potential side effects and safety concerns, particularly in patients with renal impairment and elderly patients. Managing these risks through careful prescribing and monitoring is essential to maintain market trust and compliance with regulatory requirements[5].

Generic Competition

The threat of generic competition is a significant challenge for branded pharmaceuticals. Once the patent for SEMPREX-D expires, generic versions could enter the market, potentially eroding its market share and revenue.

Key Takeaways

• Market Competition: SEMPREX-D operates in a highly competitive market, necessitating effective promotional strategies.
• Regulatory Environment: Compliance with FDA guidelines and labeling requirements is crucial.
• Promotional Strategies: DTCA and physician detailing are vital for driving demand.
• Financial Performance: Sales volume, pricing, and cost savings initiatives are key factors.
• Market Share and Pricing: Competitive pricing and market share strategies are essential.
• Challenges and Opportunities: Managing side effects and safety concerns while addressing generic competition are critical.

FAQs

1. What is SEMPREX-D used for?

   • SEMPREX-D is used to treat symptoms associated with seasonal allergic rhinitis.

2. How does DTCA impact the market for SEMPREX-D?

   • DTCA can increase both the market size of the therapeutic class and the within-class market share of SEMPREX-D.

3. What are the key safety concerns for SEMPREX-D?

   • Key safety concerns include its use in patients with diminished renal function and potential adverse reactions in elderly patients.

4. How can cost savings initiatives affect SEMPREX-D?

   • Cost savings initiatives, such as preferred drug programs, can shift market share to more cost-effective options, impacting revenue.

5. What is the potential impact of generic competition on SEMPREX-D?

   • Generic competition could significantly erode the market share and revenue of SEMPREX-D once its patent expires.

Cited Sources

1. Epstein, A. M., & Frank, R. G. (n.d.). Demand Effects of Recent Changes in Prescription Drug Promotion. National Bureau of Economic Research.
2. New York State Medicaid Preferred Drug Program Annual Report 06/07. New York State Department of Health.
3. Auxilium Pharmaceuticals Completes Acquisition Of Actient Holdings LLC. PR Newswire.
4. Acrivastine and pseudoephedrine (oral route). Mayo Clinic.
5. D Capsules (acrivastine and pseudoephedrine hydrochloride). FDA.