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Last Updated: December 22, 2024

Methdilazine hydrochloride - Generic Drug Details


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What are the generic drug sources for methdilazine hydrochloride and what is the scope of freedom to operate?

Methdilazine hydrochloride is the generic ingredient in two branded drugs marketed by Alpharma Us Pharms and Westwood Squibb, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for methdilazine hydrochloride.

Summary for methdilazine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for methdilazine hydrochloride

US Patents and Regulatory Information for methdilazine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Us Pharms METHDILAZINE HYDROCHLORIDE methdilazine hydrochloride SYRUP;ORAL 087122-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Westwood Squibb TACARYL methdilazine hydrochloride TABLET;ORAL 011950-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Westwood Squibb TACARYL methdilazine hydrochloride SYRUP;ORAL 011950-007 Approved Prior to Jan 1, 1982 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

Methdilazine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methdilazine Hydrochloride

Overview of Methdilazine Hydrochloride

Methdilazine hydrochloride is a phenothiazine compound with antihistaminic activity, primarily used to treat various dermatoses and relieve pruritus. Here’s a detailed look at its market dynamics and financial trajectory.

Mechanism of Action and Clinical Use

Methdilazine acts as a histamine H1 receptor antagonist, competing with histamine for receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract. This action provides temporary relief from symptoms such as sneezing, watery and itchy eyes, and runny nose associated with hay fever and other upper respiratory allergies[1].

Market Size and Segmentation

While specific market size data for methdilazine hydrochloride is not readily available, it can be inferred that its market is part of the broader antihistamine market. The antihistamine market is segmented based on type (prescription and over-the-counter), application (allergic rhinitis, urticaria, atopic dermatitis, etc.), and geography.

Competitive Landscape

The antihistamine market is competitive, with several established players offering a range of products. Methdilazine hydrochloride, however, is not as widely used as some other antihistamines due to its specific indications and the availability of newer, more targeted therapies.

Regulatory Status

Methdilazine hydrochloride is not approved in the US or other major markets, which significantly impacts its market dynamics. The lack of regulatory approval limits its distribution and marketing, confining its use to regions where it may still be available under different brand names or through international pharmacies[1].

Financial Trajectory

Given the lack of regulatory approvals and limited market presence, the financial trajectory for methdilazine hydrochloride is not robust. Here are some key points:

Revenue

  • The revenue generated from methdilazine hydrochloride is likely to be minimal compared to other antihistamines. This is due to its restricted market access and the preference for newer, more effective treatments.

Market Growth

  • The growth prospects for methdilazine hydrochloride are limited. The antihistamine market as a whole is growing, but this growth is driven by newer and more innovative products rather than older compounds like methdilazine hydrochloride.

Geographical Distribution

  • The drug may still be available in certain regions, particularly where regulatory standards are less stringent. However, this does not contribute significantly to its global financial performance.

Challenges and Opportunities

Challenges

  • Regulatory Hurdles: The lack of approval in major markets is a significant barrier to its financial success.
  • Competition: The presence of more effective and safer antihistamines makes it challenging for methdilazine hydrochloride to gain market share.
  • Side Effects: The drug has several adverse effects, including clumsiness, convulsions, and muscle spasms, which can deter patients and healthcare providers[1].

Opportunities

  • Niche Markets: There may be opportunities in regions where access to newer antihistamines is limited, and methdilazine hydrochloride could fill a gap in the market.
  • Generic Market: If the patent has expired, generic versions of methdilazine hydrochloride could be produced, potentially increasing its market presence.

Adverse Effects and Safety Profile

The safety profile of methdilazine hydrochloride includes several adverse effects, which can impact its market acceptance. Symptoms of overdose include clumsiness, convulsions, drowsiness, and muscle spasms, among others. These side effects can limit its prescription and use, further affecting its financial trajectory[1].

Conclusion

Methdilazine hydrochloride faces significant challenges in the market due to its lack of regulatory approvals, competitive landscape, and safety profile. While there may be niche opportunities, its overall financial trajectory is likely to remain subdued.

Key Takeaways

  • Limited Market Access: Methdilazine hydrochloride is not approved in major markets.
  • Competitive Market: The antihistamine market is dominated by newer and more effective treatments.
  • Safety Concerns: The drug has several adverse effects that can impact its market acceptance.
  • Niche Opportunities: Potential for use in regions with limited access to newer antihistamines.

FAQs

What is methdilazine hydrochloride used for?

Methdilazine hydrochloride is used to treat various dermatoses and relieve pruritus.

Is methdilazine hydrochloride approved in the US?

No, methdilazine hydrochloride is not approved in the US or other major markets[1].

What are the common side effects of methdilazine hydrochloride?

Common side effects include clumsiness, convulsions, drowsiness, and muscle spasms[1].

How does methdilazine hydrochloride work?

It acts as a histamine H1 receptor antagonist, blocking the action of histamine and providing relief from allergic symptoms[1].

What are the market prospects for methdilazine hydrochloride?

The market prospects are limited due to regulatory hurdles, competition from newer antihistamines, and safety concerns.

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