Last Updated: June 17, 2026

TAVIST-1 Drug Patent Profile


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When do Tavist-1 patents expire, and when can generic versions of Tavist-1 launch?

Tavist-1 is a drug marketed by Haleon Us Holdings and Novartis and is included in two NDAs.

The generic ingredient in TAVIST-1 is clemastine fumarate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tavist-1

A generic version of TAVIST-1 was approved as clemastine fumarate by GENUS on January 31st, 1992.

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Summary for TAVIST-1
US Patents:0
Applicants:2
NDAs:2

US Patents and Regulatory Information for TAVIST-1

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings TAVIST-1 clemastine fumarate TABLET;ORAL 020925-001 Aug 21, 1992 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novartis TAVIST-1 clemastine fumarate TABLET;ORAL 017661-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novartis TAVIST-1 clemastine fumarate TABLET;ORAL 017661-003 Aug 21, 1992 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
Last updated: February 10, 2026

What Is TAVIST-1 and Its Current Market Status?

TAVIST-1 is the brand name for the drug chlorpheniramine, an antihistamine antihistamine drug used to treat allergies, hay fever, and cold symptoms. It is an older medication, widely available in generic form, with limited recent patent activity in most jurisdictions. Its primary formulation is an oral antihistamine.

The drug's market has declined in recent years due to the emergence of newer antihistamines with fewer sedative side effects, such as loratadine or cetirizine. TAVIST-1's patent expired in the 1980s, leading to widespread generic availability.

What Are the Fundamentals Underpinning TAVIST-1 Investment Potential?

Market Size and Demand Dynamics

Global allergy and cold drug markets surpass $15 billion annually. Chlorpheniramine's segment has shrunk but remains sizable in developing regions where new-generation antihistamines are either unavailable or costly. Key points:

  • Market Penetration: Limited in developed markets due to availability of non-sedating antihistamines.
  • Emerging Markets: Potential growth in countries with less access to newer formulations.
  • Pharmacovigilance: Concerns over sedative side effects have restrained growth.

Patent and Regulatory Status

  • No active patents; generic status since the 1980s.
  • Regulatory barriers are minimal; existing approvals cover most markets.
  • Opportunities for reformulation or combination products are limited, reducing innovation incentives.

Competitive Landscape

  • Dominated by non-sedating antihistamines (loratadine, cetirizine) with better side effect profiles.
  • OTC availability constrains pricing power.
  • Limited scope for new drug development directly competing with TAVIST-1.

Development and Repurposing Opportunities

  • Potential for reformulation to reduce sedative effects.
  • Repurposing for new indications remains speculative.
  • R&D investments are unlikely to regenerate market dominance given the drug’s age and preference for newer drugs.

Investment Risks

  • Decreasing market share in core indications.
  • Competition from newer antihistamines.
  • Regulatory and market shifts favoring non-sedating options.
  • Capitation pressures and OTC status limit pricing premiums.

What Financial and Commercial Considerations Are Relevant?

  • No patent protections allow for low-cost generics, squeezing profit margins.
  • Market revenues primarily derive from regional markets that rely on older, generic drugs.
  • Minimal costs associated with R&D or regulatory renewal given generic status.
  • Potential licensing or partnership deals are unlikely to generate significant revenue streams.

How Should Investors Approach TAVIST-1?

  • Recognize the drug as low-growth, with limited near-term upside.
  • Focus on regional supply chain dynamics and generic manufacturing margins.
  • Evaluate opportunities for niche markets, such as formulations for specific populations.
  • Consider the broader portfolio exposure to antihistamines and allergy medications.

What Are the Strategic Alternatives or Focus Areas?

  • Invest in companies that own or develop newer antihistamines.
  • Monitor emerging markets where demand persists for older drugs.
  • Explore R&D efforts on reformulated versions with improved safety profiles, although this remains highly speculative.
  • Consider restructuring or licensing assets for niche applications.

Key Takeaways

  • TAVIST-1 is a first-generation antihistamine with declining market relevance.
  • Patent expiry and competition from non-sedating alternatives limit its growth potential.
  • The drug remains accessible in emerging markets, offering regional opportunities.
  • Investment prospects are constrained by commoditization, low margins, and limited innovation incentives.
  • For strategic positioning, focus on regions with unmet demand or adjacent opportunities.

FAQs

1. Is there any current patent protection on TAVIST-1?
No. The patent expired in the 1980s; the drug is available as a generic.

2. Are there any recent reformulations or new formulations of TAVIST-1?
There are limited reformulation efforts; most focus on combination products rather than the original compound.

3. What are the main competitors to TAVIST-1?
Non-sedating antihistamines like loratadine, cetirizine, and levocetirizine.

4. Could TAVIST-1 be repurposed for new medical indications?
Potentially, but current evidence and market dynamics do not favor significant repurposing.

5. Should investors consider TAVIST-1 in their portfolio?
Only for niche, regional markets or if involved in generic manufacturing; broader investment is not justified due to limited growth prospects.


References

  1. Global Market Insights. (2022). Allergy and Cold Therapy Market.
  2. U.S. FDA. Drug approval history for chlorpheniramine.
  3. IMS Health. (2021). OTC antihistamine market analysis.
  4. European Medicines Agency. Product authorization for antihistamines.
  5. PHRMA. (2020). Trends in generic drug market.

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