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Last Updated: December 22, 2024

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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

Acrivastine; pseudoephedrine hydrochloride is the generic ingredient in one branded drug marketed by Endo Operations and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

US Patents and Regulatory Information for ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE

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 ⤷  Subscribe ⤷  Subscribe
Endo Operations SEMPREX-D acrivastine; pseudoephedrine hydrochloride CAPSULE;ORAL 019806-001 Mar 25, 1994 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acrivastine; Pseudoephedrine Hydrochloride

Introduction

Acrivastine and pseudoephedrine hydrochloride, combined in products like Semprex-D, are widely used for the treatment of allergic rhinitis and other allergic conditions. This combination of an antihistamine (acrivastine) and a decongestant (pseudoephedrine) has shown significant efficacy in relieving a broad range of allergy symptoms.

Market Size and Growth

The human antihistamine drug market, which includes products like acrivastine and pseudoephedrine hydrochloride, is experiencing robust growth. By 2033, the market is projected to reach approximately USD 706.2 million, up from USD 274.8 million in 2023, with a Compound Annual Growth Rate (CAGR) of 9.9% between 2024 and 2033[3].

Dominant Drug Type

Second-generation antihistamines, such as acrivastine, hold a significant market share, accounting for over 62.7% of the market in 2023. This dominance is due to their improved safety profiles and reduced sedative effects compared to first-generation antihistamines[3].

Preferred Medication Type

Over-the-Counter (OTC) drugs, which include many antihistamine and decongestant combinations, lead the market with a 60.7% market share in 2023. This preference reflects consumer demand for accessible, non-prescription solutions for allergy relief[3].

Top Indication

Allergy treatments, including those involving acrivastine and pseudoephedrine, capture a substantial market share, with 62.7% of the market in 2023. This indicates a high demand for effective antihistamine medications to manage allergic conditions[3].

Leading Route of Administration

Oral administration, the typical route for acrivastine and pseudoephedrine hydrochloride, claims 46.1% of the market share in 2023. This is driven by the user-friendliness and widespread acceptance of oral medications among patients[3].

Primary End-User

Hospitals secure a commanding 46.8% market share in 2023, highlighting their crucial role in addressing diverse allergic conditions in patients. This indicates that a significant portion of the revenue from these drugs comes from hospital prescriptions and treatments[3].

Regional Analysis

North America is a key player in the human antihistamine drug market, holding a substantial 37.2% market share in 2023. This region's strong market presence is attributed to increased awareness about allergy management, a high incidence of allergic conditions, and a proactive approach to healthcare[3].

Safety and Efficacy

Clinical trials have demonstrated that the combination of acrivastine and pseudoephedrine is significantly more effective than either component alone or a placebo in relieving allergy symptoms. This combination has been shown to be rational, safe, and effective for the treatment of allergic rhinitis, with each component contributing to the overall efficacy[1].

Pharmacokinetics and Safety Considerations

Acrivastine and pseudoephedrine have distinct pharmacokinetic profiles. Acrivastine exhibits linear kinetics, with a short half-life that prevents accumulation in the plasma following multiple dosing. However, in patients with chronic renal insufficiency, the elimination half-life of acrivastine and its metabolites is significantly prolonged[2].

Pseudoephedrine, on the other hand, has been associated with rare but serious side effects such as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). As a result, regulatory bodies have issued guidelines to minimize these risks, including contraindications for patients with severe or uncontrolled hypertension or severe kidney disease[4].

Adverse Events

Clinical investigations have shown that the combination of acrivastine and pseudoephedrine is generally well-tolerated. However, common adverse events include somnolence, headache, dizziness, nervousness, insomnia, nausea, and dry mouth. These events are typically mild and occur at frequencies comparable to or slightly higher than those seen with placebo[2].

Financial Trajectory

Given the growing demand for antihistamine and decongestant combinations, the financial trajectory for acrivastine and pseudoephedrine hydrochloride is positive. The increasing prevalence of allergic conditions, coupled with innovations in drug research and development, is expected to drive market growth.

Revenue Projections

The market for human antihistamine drugs, including those containing acrivastine and pseudoephedrine, is projected to more than double by 2033. This growth will be driven by expanding healthcare infrastructure, increasing awareness about allergic disorders, and consumer preference for effective and accessible treatments[3].

Competitive Landscape

The competitive environment in the antihistamine market is dynamic, with major market participants continuously innovating and aligning their strategies to meet the growing demand. This competition is expected to drive further research and development, potentially leading to new formulations and improved safety profiles[3].

Key Takeaways

  • The human antihistamine drug market, including products like acrivastine and pseudoephedrine hydrochloride, is expected to grow significantly, reaching USD 706.2 million by 2033.
  • Second-generation antihistamines and OTC drugs dominate the market due to their safety profiles and accessibility.
  • North America is a key region, driven by high awareness and incidence of allergic conditions.
  • The combination of acrivastine and pseudoephedrine is safe and effective but requires careful consideration of potential side effects, especially in patients with renal insufficiency or uncontrolled hypertension.
  • Regulatory guidelines are in place to minimize the risks associated with pseudoephedrine.

FAQs

What is the primary indication for acrivastine and pseudoephedrine hydrochloride?

The primary indication for acrivastine and pseudoephedrine hydrochloride is the treatment of allergic rhinitis and other allergic conditions.

How does the combination of acrivastine and pseudoephedrine compare to each component alone?

The combination of acrivastine and pseudoephedrine is significantly more effective than either component alone or a placebo in relieving allergy symptoms[1].

What are the potential side effects of pseudoephedrine?

Pseudoephedrine is associated with rare but serious side effects such as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Common adverse events include somnolence, headache, and dry mouth[2][4].

Can patients with renal insufficiency use acrivastine and pseudoephedrine?

Patients with chronic renal insufficiency should use these medications with caution, as the elimination half-life of acrivastine and its metabolites is significantly prolonged in such patients[2].

What is the projected market size for human antihistamine drugs by 2033?

The human antihistamine drug market is projected to reach approximately USD 706.2 million by 2033, growing at a CAGR of 9.9% from 2024 to 2033[3].

Sources

  1. Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis - PubMed[1]
  2. D Capsules (acrivastine and pseudoephedrine hydrochloride) - DailyMed[2]
  3. Human Antihistamine Drug Market Size - Market.us[3]
  4. Pseudoephedrine-containing medicinal products - referral - EMA[4]

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