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Last Updated: March 27, 2026

TACARYL Drug Patent Profile


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When do Tacaryl patents expire, and when can generic versions of Tacaryl launch?

Tacaryl is a drug marketed by Westwood Squibb and is included in one NDA.

The generic ingredient in TACARYL is methdilazine. There are four drug master file entries for this compound. Additional details are available on the methdilazine profile page.

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Questions you can ask:
  • What is the 5 year forecast for TACARYL?
  • What are the global sales for TACARYL?
  • What is Average Wholesale Price for TACARYL?
Summary for TACARYL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 22
Patent Applications: 2,368
DailyMed Link:TACARYL at DailyMed
Drug patent expirations by year for TACARYL

US Patents and Regulatory Information for TACARYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Westwood Squibb TACARYL methdilazine hydrochloride SYRUP;ORAL 011950-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Westwood Squibb TACARYL methdilazine TABLET, CHEWABLE;ORAL 011950-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Westwood Squibb TACARYL methdilazine hydrochloride TABLET;ORAL 011950-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Tacaryl (Chlorpheniramine Maleate)

Last updated: February 20, 2026

What is Tacaryl and how is it positioned in the market?

Tacaryl (chlorpheniramine maleate) is an antihistamine used primarily for allergic conditions such as hay fever, allergic conjunctivitis, and allergic rhinitis. First introduced in the 1940s, it remains on the market as an over-the-counter (OTC) medication in many regions. It faces competition from second-generation antihistamines, which are preferred for fewer sedative effects.

Market size and growth trends

The global antihistamine market was valued at US$3.2 billion in 2021, with expectations to grow at a compound annual growth rate (CAGR) of 4% from 2022 through 2028.[1] Chlorpheniramine-based products account for an estimated 15% of this market segment, with OTC formulations dominating sales.

Key drivers

  • Increased prevalence of allergic rhinitis and other allergic conditions.
  • Growing awareness and demand for OTC allergy medications.
  • Consumer preference for cost-effective, readily available medications.

Regional distribution

  • North America: 40%
  • Europe: 25%
  • Asia-Pacific: 20%
  • Rest of World: 15%

North America and Europe dominate due to high allergy diagnosis rates and OTC product accessibility.

Competitive landscape

Chlorpheniramine market is fragmented among brands such as:

  • Chlor-Trimeton (Johnson & Johnson)
  • Chlorpheniramine Maleate tablets (generic)
  • Other regional brands

Second-generation antihistamines like loratadine, cetirizine, and fexofenadine are expanding market share, citing better side-effect profiles.

Key competitors' financial impact

  • Johnson & Johnson reported US$2.3 billion in sales for OTC antihistamines in 2022, with less than 5% attributable to chlorpheniramine products.
  • Generics dominate, with numerous manufacturers producing chlorpheniramine formulations at low cost, pressing margins on branded products.

Regulatory environment and patent considerations

Chlorpheniramine has been off-patent since the 1970s, resulting in widespread generic availability. Manufacturers must navigate regulations in each region, including:

  • US FDA regulations for OTC labeling and safety.
  • EMA guidelines for European markets.
  • Chinese and Indian regulatory agencies for the Asia-Pacific.

The absence of patent barriers allows for low entry costs but limits premium pricing strategies.

Financial trajectory outlook

  • Revenue trends: Expected slight decline in sales, given market maturity and competition from second-generation antihistamines.
  • Profitability: Margins are thin due to price competition. Brand-name products sustain slightly higher margins but face pressure.
  • Pricing: OTC sales are driven by low prices; no significant premium can be charged.
  • Market opportunities: Expansion into emerging markets with growing allergy prevalence could stabilize revenue streams.

Risks and challenges

  • Evolving preferences: Shift toward non-sedating antihistamines reduces demand.
  • Regulatory changes: Potential new safety requirements could impact manufacturing.
  • Pricing pressure: Increased generic competition limits pricing power.

Strategic insights

  • Companies should focus on formulation improvements, such as combining chlorpheniramine with other active ingredients.
  • Market penetration in developing regions remains an avenue for growth.
  • Investment in consumer education to reinforce OTC accessibility could elevate market share.

Key takeaways

  • The TACARYL (chlorpheniramine maleate) market is mature with limited growth prospects.
  • Most revenues derive from low-cost generics, with brand premiums under pressure.
  • Second-generation antihistamines dominate newer markets, influencing demand.
  • Regional expansion and formulation innovation represent potential revenue streams.
  • Regulatory and competitive pressures necessitate strategic adaptation.

FAQs

1. What are the main competitors of TACARYL in the antihistamine market?
Second-generation antihistamines such as loratadine, cetirizine, and fexofenadine dominate newer markets, offering better tolerability and fewer sedative effects.

2. How has patent expiry affected TACARYL?
Patent expiry in the 1970s led to widespread generic availability, decreasing market exclusivity and limiting profit margins for branded formulations.

3. Are there new formulations or combinations involving chlorpheniramine?
Some formulations combine chlorpheniramine with decongestants or other active ingredients, targeting specific allergy symptoms.

4. What regional markets present growth opportunities?
Emerging markets in Asia, Latin America, and parts of Africa show rising prevalence of allergic conditions and low OTC medication penetration, creating growth opportunities.

5. How does regulatory environment influence TACARYL's market?
Regulations favor OTC sales in developed regions, but safety standards and labeling requirements can pose barriers for entry and expansion.


References

[1] Market Research Future. (2022). Global Antihistamines Market Analysis.

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