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Last Updated: December 22, 2024

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for ibuprofen; pseudoephedrine hydrochloride and what is the scope of patent protection?

Ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in six branded drugs marketed by Haleon Us Holdings, Aurobindo Pharma, J And J Consumer Inc, Perrigo, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, and Ohm Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound.

Summary for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Recent Clinical Trials for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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

SponsorPhase
Institut für Pharmakologie und Präventive MedizinPhase 1
Pharma Medica Research, Inc.Phase 1
Boehringer IngelheimPhase 1

See all IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
C01CA Adrenergic and dopaminergic agents
C01C CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01 CARDIAC THERAPY
C Cardiovascular system
C01EB Other cardiac preparations
C01E OTHER CARDIAC PREPARATIONS
C01 CARDIAC THERAPY
C Cardiovascular system
G02CC Antiinflammatory products for vaginal administration
G02C OTHER GYNECOLOGICALS
G02 OTHER GYNECOLOGICALS
G Genito-urinary system and sex hormones
M01AE Propionic acid derivatives
M01A ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01 ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M Musculo-skeletal system
M02AA Antiinflammatory preparations, non-steroids for topical use
M02A TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02 TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M Musculo-skeletal system
R01AA Sympathomimetics, plain
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R01AB Sympathomimetics, combinations excl. corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R01BA Sympathomimetics
R01B NASAL DECONGESTANTS FOR SYSTEMIC USE
R01 NASAL PREPARATIONS
R Respiratory system
R02AX Other throat preparations
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
R03CA Alpha- and beta-adrenoreceptor agonists
R03C ADRENERGICS FOR SYSTEMIC USE
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
S01FB Sympathomimetics excl. antiglaucoma preparations
S01F MYDRIATICS AND CYCLOPLEGICS
S01 OPHTHALMOLOGICALS
S Sensory organs

US Patents and Regulatory Information for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
J And J Consumer Inc CHILDREN'S MOTRIN COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021128-001 Aug 1, 2000 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 076478-001 Nov 5, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374-001 May 30, 2002 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 213565-001 Mar 10, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 077628-001 Aug 14, 2006 OTC No 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 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ibuprofen and Pseudoephedrine Hydrochloride

Introduction to Ibuprofen and Pseudoephedrine Hydrochloride

Ibuprofen and Pseudoephedrine Hydrochloride are two widely used pharmaceuticals with distinct applications and market dynamics.

  • Ibuprofen: A nonsteroidal anti-inflammatory drug (NSAID) used to alleviate pain, fever, and inflammation. It is commonly known by brand names such as Advil and Motrin[1].
  • Pseudoephedrine Hydrochloride: A decongestant used to relieve nasal congestion in the upper respiratory tract. It is often found in cold and allergy medications[2].

Market Size and Growth Projections for Ibuprofen

The Ibuprofen market is anticipated to experience significant growth over the next decade.

  • Current Market Size: Valued at approximately USD 97 million in 2023[1].
  • Projected Market Size: Expected to reach around USD 205.6 million by 2033[1].
  • Compound Annual Growth Rate (CAGR): Forecasted at 7.8% from 2024 to 2033[1].

Key Drivers of Ibuprofen Market Growth

Several factors are driving the growth of the Ibuprofen market:

  • Increasing Chronic Pain Conditions: The rising incidence of chronic pain conditions such as rheumatoid arthritis and osteoarthritis is a major driver. For instance, rheumatoid arthritis affects approximately 1% of the population in India, impacting around 1 million people[4].
  • Efficacy and Accessibility: Ibuprofen’s effectiveness in pain management and its widespread availability over-the-counter and through prescriptions contribute to its market growth[1].
  • Aging Population: The growing geriatric population, which is more prone to chronic pain and inflammatory conditions, also supports market expansion[4].

Market Segmentation for Ibuprofen

The Ibuprofen market is segmented in various ways:

  • By Formulation: Tablets lead with a 41.6% market share in 2023, followed by capsules and syrups. Other forms include injections and others[1].
  • By Application: Rheumatoid arthritis and osteoarthritis segments command a significant market share of 30.8% in 2023, followed by cancer-related applications and general pain relief[1].

Regional Analysis for Ibuprofen

  • North America: Emerged as the leading region in 2023, capturing more than 41.6% of the market share. This is due to substantial healthcare expenditure, a well-established pharmaceutical industry, and a robust distribution network[1].

Challenges in the Ibuprofen Market

Despite the growth, the Ibuprofen market faces several challenges:

  • Regulatory Scrutiny: Stringent regulatory frameworks and approval processes can delay the introduction of new Ibuprofen products to the market[1].
  • Competition: The market is highly competitive, with multiple manufacturers vying for market share[3].

Market Size and Growth Projections for Pseudoephedrine Hydrochloride

The Pseudoephedrine Hydrochloride market also shows promising growth.

  • Current Market Size: Although specific current figures are not provided, the market is expected to grow significantly from 2024 to 2030[2].
  • Projected Growth: The global market is estimated to increase at a CAGR during the forecast period, though exact figures are not specified[2].

Key Drivers of Pseudoephedrine Hydrochloride Market Growth

Several factors contribute to the growth of the Pseudoephedrine Hydrochloride market:

  • Increasing Demand for Cold and Allergy Medications: The frequent occurrence of upper respiratory tract infections and allergies drives the demand for decongestants like Pseudoephedrine Hydrochloride[2].
  • Geographical Expansion: Growth in regions such as North America, Europe, and Asia Pacific, driven by increasing healthcare expenditure and awareness of respiratory health[2].

Market Segmentation for Pseudoephedrine Hydrochloride

The market is segmented as follows:

  • By Type: Purity levels of ≥98% and ≥99% are key segments[2].
  • By Application: Capsules and tablets are the primary application segments[2].
  • By Region: North America, Europe, Asia Pacific, South America, and the Middle East and Africa are the main regional markets[2].

Key Manufacturers in the Pseudoephedrine Hydrochloride Market

  • Global Key Players: Include Malladi, Selectchemie AG, Sun Pharmaceutical, Nortec Química, Embio, Dephis Pharma, Apeloa Pharmaceutical, and Chifeng Arker Pharmaceutical[2].

Challenges in the Pseudoephedrine Hydrochloride Market

  • Regulatory Challenges: Similar to Ibuprofen, the Pseudoephedrine Hydrochloride market faces regulatory scrutiny, which can impact the introduction of new products and market growth[2].
  • Competitive Landscape: The market is competitive, with multiple players vying for market share, which can lead to pricing pressures and other competitive challenges[2].

Financial Trajectory Comparison

  • Ibuprofen: Expected to grow from USD 97 million in 2023 to USD 205.6 million by 2033 at a CAGR of 7.8%[1].
  • Pseudoephedrine Hydrochloride: While exact figures are not provided, the market is expected to grow at a CAGR from 2024 to 2030, indicating a positive financial trajectory[2].

Key Takeaways

  • Ibuprofen:
    • Strong growth driven by chronic pain conditions and an aging population.
    • Dominant in North America due to robust healthcare infrastructure.
    • Faces regulatory and competitive challenges.
  • Pseudoephedrine Hydrochloride:
    • Growth driven by demand for cold and allergy medications.
    • Segmented by purity levels and applications.
    • Key players include several global pharmaceutical companies.
    • Faces regulatory and competitive challenges.

FAQs

1. What is the projected CAGR for the Ibuprofen market from 2024 to 2033? The Ibuprofen market is expected to grow at a CAGR of 7.8% from 2024 to 2033[1].

2. Which region dominates the Ibuprofen market? North America dominates the Ibuprofen market, capturing more than 41.6% of the market share in 2023[1].

3. What are the key drivers of the Pseudoephedrine Hydrochloride market? The key drivers include increasing demand for cold and allergy medications and geographical expansion in regions like North America, Europe, and Asia Pacific[2].

4. Who are the key manufacturers in the Pseudoephedrine Hydrochloride market? Key manufacturers include Malladi, Selectchemie AG, Sun Pharmaceutical, Nortec Química, Embio, Dephis Pharma, Apeloa Pharmaceutical, and Chifeng Arker Pharmaceutical[2].

5. What are the main challenges faced by both the Ibuprofen and Pseudoephedrine Hydrochloride markets? Both markets face regulatory scrutiny and a highly competitive landscape, which can impact market growth and product introduction[1][2].

Cited Sources

  1. Market.us: Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%[1]
  2. QYResearch: Global Pseudoephedrine Hydrochloride Market Insights, Forecast to 2030[2]
  3. Biospace: Ibuprofen Market Size, Developments Status, Trends and Key Players Analysis, Forecast 2027[3]
  4. Grand View Research: Ibuprofen API Market Size, Share & Growth Report, 2030[4]

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