Last Updated: June 17, 2026

PHYLLOCONTIN Drug Patent Profile


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

Phyllocontin is a drug marketed by Pharm Res Assoc and is included in one NDA.

The generic ingredient in PHYLLOCONTIN is aminophylline. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aminophylline profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Phyllocontin

A generic version of PHYLLOCONTIN was approved as aminophylline by HOSPIRA on October 26th, 1983.

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Summary for PHYLLOCONTIN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for PHYLLOCONTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Res Assoc PHYLLOCONTIN aminophylline TABLET, EXTENDED RELEASE;ORAL 086760-001 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

Investment and Fundamentals Analysis of Phyllocontin (aminophylline)

Last updated: February 20, 2026

What is Phyllocontin and its Current Market Position?

Phyllocontin (aminophylline) is a bronchodilator used primarily to treat respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other airway constriction disorders. It is a combination of theophylline and ethylenediamine, formulated to enhance solubility and bioavailability.

Phyllocontin remains entrenched in hospital formulary pipelines globally, though its market share has decreased due to newer agents. Key players include Boehringer Ingelheim, which markets the proprietary formulation.

What are the core market drivers for Phyllocontin?

  • Medical adoption in acute and chronic respiratory disease management.
  • Existing manufacturing infrastructure and patent expirations promoting generics.
  • Strong inhalational therapy positioning with a high patient base.

What are the growth prospects and market challenges?

Market size: The global bronchodilator market was valued at USD 10.2 billion in 2022 and is projected to grow at a CAGR of approximately 4% through 2030. Aminophylline accounts for a small but stable segment within this space.

Challenges:

  • Competition from modern inhalers like beta-agonists, corticosteroids.
  • Stringent regulatory oversight.
  • Limited pipeline for reformulations or novel derivatives.

What are the key regulatory and patent considerations?

  • The original patent for aminophylline expired decades ago.
  • No recent filings for new chemical entities based on aminophylline.
  • Generic competition dominates the landscape with multiple manufacturers offering bioequivalent products.
  • Regulatory agencies have maintained existing approvals without requiring significant new data, confirming market stability.

What are the R&D and investment risks?

  • Low potential for pipeline innovation—reaujth of new production methods or orphan indications looks limited.
  • Dependence on hospital procurement channels, which face cost-containment pressures.
  • Marginal revenue growth prospects, with the drug’s visibility declining against newer therapies.
  • Price erosion expected due to widespread generics, affecting margins.

Financials and Market Access

  • Pricing: Variability across markets; hospital formulary policies heavily influence pricing strategies.

    Region Price Range (USD/tablet) Market Share
    North America 0.08 - 0.15 Moderate
    Europe 0.05 - 0.12 Stable
    Asia-Pacific 0.03 - 0.09 Growing
  • Distribution channels include hospitals and pharmacies with minimal online retail presence.

Investment Considerations

  • Advantages: Established therapy, stable demand in acute settings, production cost efficiencies.
  • Disadvantages: Competitive generic landscape, limited growth, low innovation potential.

Conclusion

Phyllocontin operates within a mature, commoditized segment of the respiratory pharmaceutical market. It offers stable cash flow prospects in hospital settings but faces declining market share against newer, more convenient, and targeted therapies. Any investment hinges on stabilization rather than growth, with significant competition driving price erosion.

Key Takeaways

  • Phyllocontin’s market is stable but mature, with minimal innovation.
  • Generics dominate, exerting downward pressure on prices.
  • Growth prospects are limited to replacement demand and institutional use.
  • Regulatory pathways remain straightforward due to patent expirations.
  • Competitive landscape favors cost leaders, not innovative entrants.

FAQs

Q1: How does Phyllocontin compare to newer bronchodilators?
Newer inhalers like tiotropium, salmeterol, and combination therapies outperform aminophylline in efficacy, convenience, and side-effect profiles, reducing Phyllocontin’s market attractiveness.

Q2: What are the future opportunities for Phyllocontin?
Limited; potential exists in niche or orphan indications, but none are currently under active development. Generic competition remains the core market.

Q3: What risks are associated with investing in Phyllocontin?
Regulatory risks are low, but market share erosion from newer therapies and regulatory pressures to reduce hospital costs pose significant threats.

Q4: Could reformulation or combination therapy restore growth?
Unlikely; the chemical structure is well established. Reformulation efforts face generic competition and limited demand.

Q5: Which geographic markets offer the highest growth potential?
Emerging markets like Asia-Pacific present opportunities due to rising respiratory disease incidence and expanding hospital infrastructure.


References

  1. Grand View Research. (2022). Bronchodilator Market Size & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/bronchodilator-market
  2. Boehringer Ingelheim. (2022). Product Information for Phyllocontin.
  3. U.S. Food and Drug Administration. (2023). Approved Drugs Database.
  4. MarketsandMarkets. (2022). Respiratory Disease Drugs Market Forecast.
  5. European Medicines Agency. (2023). Summary of Product Characteristics.

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