You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for chlorpheniramine maleate; hydrocodone bitartrate and what is the scope of freedom to operate?

Chlorpheniramine maleate; hydrocodone bitartrate is the generic ingredient in four branded drugs marketed by Acella, Tris Pharma Inc, Persion, Mayne Pharma Inc, Padagis Us, and Sciegen Pharms Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Summary for CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
US Patents:0
Tradenames:4
Applicants:6
NDAs:8
DailyMed Link:CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE at DailyMed

US Patents and Regulatory Information for CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma Inc HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 205657-001 Aug 3, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Padagis Us HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 204627-001 Apr 29, 2014 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Acella HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; hydrocodone bitartrate SOLUTION;ORAL 206891-001 Jun 9, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Tris Pharma Inc HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 203838-001 Nov 26, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Persion VITUZ chlorpheniramine maleate; hydrocodone bitartrate SOLUTION;ORAL 204307-001 Feb 20, 2013 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 206660-001 May 15, 2017 DISCN 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

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE Market Analysis and Financial Projection Experimental

Chlorpheniramine Maleate and Hydrocodone Bitartrate: Market Dynamics and Financial Trajectory

Introduction to Chlorpheniramine Maleate and Hydrocodone Bitartrate

Chlorpheniramine maleate and hydrocodone bitartrate are two pharmaceutical compounds often combined in medications to treat various allergic and respiratory conditions. Chlorpheniramine maleate is an antihistamine, while hydrocodone bitartrate is a narcotic antitussive. Understanding their market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth Projections

The chlorpheniramine maleate market is projected to experience significant growth over the next decade. As of 2022, the market size was valued at approximately $468.6 million and is expected to reach $751.4 million by 2032, growing at a CAGR of 4.9%[3].

Similarly, the market for chlorpheniramine maleate is forecasted to grow from $0.5 billion in 2022 to $0.74 billion by 2030, with a steady CAGR of 5.5%[1].

Key Drivers of Market Growth

Rising Prevalence of Allergies

The increasing prevalence of allergic illnesses worldwide is a major driver of the chlorpheniramine maleate market. Allergic rhinitis, hay fever, and other respiratory conditions are on the rise, particularly in low- and middle-income countries. For instance, approximately 81 million people in the U.S. were diagnosed with seasonal allergic rhinitis in 2021[3].

Advancements in Pharmaceutical Technology

Advances in pharmaceutical technology and drug delivery systems have led to the development of new formulations such as extended-release tablets and liquid formulations. These innovations offer improved efficacy, convenience, and patient compliance, which are expected to open new potential for market growth[1][3].

Increased Investments in R&D

Pharmaceutical companies are investing heavily in R&D activities to develop more potent and effective antihistaminic drugs. This surge in R&D efforts is anticipated to provide novel medicines with fewer side effects and improved efficacy, further driving market growth[1][3].

Regional Market Dynamics

North America

North America is expected to dominate the chlorpheniramine maleate market during the forecast period. The presence of major companies like Cardinal Health, Inc. and a large patient pool seeking treatment contribute to the rapid growth in this region[1].

Asia Pacific

The Asia Pacific region presents a significant opportunity for the chlorpheniramine maleate market due to the increasing prevalence of allergic reactions. Urbanization and environmental pollution have led to a rise in allergy cases, making countries like India key markets for chlorpheniramine maleate[1].

Emerging Economies

Emerging economies such as India, China, Mexico, and Brazil are expected to offer lucrative opportunities due to the surge in unhealthy and sedentary lifestyles, rise in the geriatric population, and increase in the prevalence of allergic conditions[3].

Challenges and Restraints

Availability of Alternative Medications

The availability of newer antihistamines with enhanced efficacy and fewer side effects, such as loratadine or cetirizine, poses a significant threat to the chlorpheniramine maleate market. Patients and healthcare professionals are increasingly opting for these alternative medications[1].

Potential Side Effects

Chlorpheniramine maleate is associated with potential side effects such as drowsiness, dry mouth, blurred vision, and urinary retention. These side effects can hamper the growth of the market during the forecast period[3].

Hydrocodone Bitartrate: Specific Considerations

Respiratory Depression

Hydrocodone bitartrate, when combined with chlorpheniramine maleate, poses a risk of dose-related respiratory depression. This is a critical consideration, especially in patients with pulmonary disease or those with impaired renal function[2][4].

Co-administration with Other Medications

The concurrent use of hydrocodone bitartrate with anticholinergics can produce paralytic ileus, and caution is advised in patients with acute abdominal conditions or other coexisting conditions such as thyroid disease, Addison’s disease, or asthma[4].

Financial Trajectory

The financial trajectory of chlorpheniramine maleate is positive, with steady growth projected over the next decade. The market is expected to reach $751.4 million by 2032, driven by the increasing prevalence of allergies and advancements in pharmaceutical technology[3].

For hydrocodone bitartrate, the financial outlook is closely tied to its use in combination with chlorpheniramine maleate. The demand for these combination medications, particularly for relief of cough and upper respiratory symptoms, contributes to the overall financial growth of the market.

Competitive Landscape

The chlorpheniramine maleate market is highly competitive, with several large pharmaceutical companies, generic drug manufacturers, and contract manufacturing organizations vying for market dominance. Key players include Capellon Pharmaceuticals, GlaxoSmithKline plc, Viatris Inc., Johnson & Johnson, and Sun Pharmaceutical Industries Limited[3].

Supply Side Dynamics

China and India are among the top suppliers of chlorpheniramine maleate due to their substantial pharmaceutical production capacities. These countries play a crucial role in the global supply chain of this drug[1].

Key Takeaways

  • The chlorpheniramine maleate market is expected to grow significantly due to the rising prevalence of allergies and advancements in pharmaceutical technology.
  • North America and the Asia Pacific region are key markets, with emerging economies offering lucrative opportunities.
  • The availability of alternative medications and potential side effects are significant challenges.
  • Hydrocodone bitartrate, when combined with chlorpheniramine maleate, requires careful consideration due to its potential for respiratory depression and other side effects.
  • The competitive landscape is dominated by major pharmaceutical companies and generic drug manufacturers.

Frequently Asked Questions

What are the primary uses of chlorpheniramine maleate?

Chlorpheniramine maleate is used in the treatment of various allergic conditions such as allergic rhinitis (hay fever), relieving symptoms like red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies and the common cold[3].

What are the potential side effects of chlorpheniramine maleate?

Potential side effects include drowsiness, dry mouth, blurred vision, and urinary retention. These side effects can hamper the growth of the market[3].

How does hydrocodone bitartrate affect respiratory function?

Hydrocodone bitartrate produces dose-related respiratory depression by directly acting on brain stem respiratory centers. This can be particularly risky in patients with pulmonary disease or impaired renal function[2][4].

Which regions are expected to dominate the chlorpheniramine maleate market?

North America is expected to dominate the market, followed by Europe. The Asia Pacific region, particularly countries like India, is also expected to see significant growth[1][3].

What are the key drivers of the chlorpheniramine maleate market growth?

The key drivers include the rising prevalence of allergic illnesses, advancements in pharmaceutical technology, and increased investments in R&D activities by pharmaceutical companies[1][3].

Cited Sources

  1. Fairfield Market Research: "Chlorpheniramine Maleate Market Reach US$0.74 Bn By 2030"
  2. DailyMed: "Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Oral Suspension"
  3. Allied Market Research: "Chlorpheniramine Maleate Market Statistics and Forecast - 2032"
  4. Drugs.com: "Hydrocodone and Chlorpheniramine Solution: Package Insert"

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.