Last Updated: May 3, 2026

AMINOPHYLLIN Drug Patent Profile


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Which patents cover Aminophyllin, and when can generic versions of Aminophyllin launch?

Aminophyllin is a drug marketed by Gd Searle Llc, Abraxis Pharm, Am Regent, Elkins Sinn, Hospira, Intl Medication, King Pharms, Luitpold, Lyphomed, Pharma Serve Ny, Smith And Nephew, Teva Parenteral, Morton Grove, Roxane, Impax Labs, Tablicaps, Vale, Ani Pharms, Ascot, Barr, Chartwell Molecular, Duramed Pharms Barr, Halsey, Hikma Intl Pharms, Kv Pharm, Pal Pak, Panray, Purepac Pharm, Valeant Pharm Intl, Vangard, Vintage Pharms, Watson Labs, and Actavis Mid Atlantic. and is included in sixty-one NDAs.

The generic ingredient in AMINOPHYLLIN 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 Aminophyllin

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

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Summary for AMINOPHYLLIN
US Patents:0
Applicants:33
NDAs:61
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 5,441
DailyMed Link:AMINOPHYLLIN at DailyMed

US Patents and Regulatory Information for AMINOPHYLLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duramed Pharms Barr AMINOPHYLLINE aminophylline TABLET;ORAL 088183-001 Mar 31, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ani Pharms AMINOPHYLLINE aminophylline TABLET;ORAL 085261-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pal Pak AMINOPHYLLINE aminophylline TABLET;ORAL 084533-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Vintage Pharms AMINOPHYLLINE aminophylline TABLET;ORAL 085410-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Impax Labs AMINOPHYLLINE aminophylline TABLET;ORAL 084574-001 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

AMINOPHYLLIN: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is AMINOPHYLLIN’s market structure and pricing power?

AMINOPHYLLIN is a well-established, off-patent bronchodilator and xanthine derivative used for respiratory conditions (notably asthma and COPD) and in hospital acute-care settings. The market dynamics reflect a mature, low-innovation therapeutic class with broad generic availability in most established markets.

Key market structure attributes

  • Generic-dominated: The drug has long-standing commercial history and is widely supplied as generics and line extensions rather than as brand-only revenue.
  • Price compression is structurally expected: Multiple manufacturers with equivalent therapeutic intent lead to tender-driven procurement and frequent downward pricing cycles in public and hospital channels.
  • Channel mix favors institutions: Hospital use for acute exacerbations drives repeat procurement via formularies and bulk purchasing.

Implications for pricing power

  • Pricing power typically sits with low-cost, high-volume suppliers that can win tenders and sustain supply chain reliability rather than with differentiated product owners.
  • Competitive advantage often shifts to packaging, stability, supply assurance, and logistics compliance rather than product novelty.

What demand drivers shape AMINOPHYLLIN volumes?

Demand is primarily driven by respiratory disease burden and inpatient acute-care cycles, with utilization influenced by local guideline adherence and substitution patterns.

Core demand drivers

  • COPD and asthma prevalence: Routine management and exacerbation events create recurring need for bronchodilator therapy.
  • Acute-care protocols: In emergency and inpatient settings, aminophylline can appear in pharmacotherapy pathways, especially where intravenous bronchodilation is required.
  • Access and procurement mechanisms: Tender schedules, formulary updates, and substitution policies affect net volume and realized price.

Volume sensitivity

  • Volume is typically less elastic than brand medicines because aminophylline is treated as a functional necessity in acute bronchodilation pathways, but realized revenue remains sensitive to procurement intensity and manufacturer substitution.

How do competitors and generics impact financial performance?

Competitive pressure is dominated by generic manufacturers, often competing on:

  • Tender pricing
  • Availability
  • Regulatory status per market
  • Hospital contracting and rebate structures (where applicable)

Typical competitive outcomes

  • Gross margin compression: As procurement shifts to the lowest-cost compliant supplier, margin narrows.
  • Revenue dilution through substitution: Even where use persists, the revenue may shift rapidly between suppliers.

What is the likely financial trajectory for AMINOPHYLLIN?

Given the mature lifecycle and generic supply environment, the financial trajectory for aminophylline typically follows a pattern:

  1. Stable to modestly declining net pricing
  2. Relatively steadier volumes tied to respiratory care use
  3. Profit pool migration to manufacturers with lowest total cost and best tender performance
  4. Limited upside from new clinical differentiation unless a new formulation or route meaningfully changes adoption

Directionally expected trajectory

  • Revenue (industry): generally flat to declining in price terms, with volume changes depending on local prescribing and acute-care protocols.
  • Earnings (supplier level): margin volatility tracks tender outcomes and input costs (raw material, packaging, sterile or non-sterile manufacturing capability if applicable).
  • Cash flow characteristics: consistent procurement can support working capital stability, but the cash conversion is sensitive to contract terms and inventory management.

What product and regulatory factors influence near-term earnings?

Market earnings are sensitive to operational and regulatory execution more than to marketing-led dynamics.

Operational levers

  • Manufacturing scale: larger production runs lower unit cost.
  • Stability and compliance: ability to meet shelf-life and pharmacopoeial requirements without batch failures reduces costly disruptions.
  • Formulation/strength breadth: supplying multiple presentations (if applicable in local markets) supports institutional contracts and prevents substitution.

Regulatory and supply levers

  • Batch release timelines and market authorization renewals can affect fill rates and tender participation.
  • Shortages and recalls can temporarily lift prices but often do not create long-term revenue gains in generics, since competitor re-entry stabilizes supply.

What does the financial trajectory look like by scenario (pricing vs volume)?

Aminophylline’s revenue sensitivity can be framed as:

Revenue = Price x Volume

  • Price effect dominates in generic tender environments.
  • Volume effect dominates only if local clinical practice materially shifts.

Scenario matrix (supply-led generics)

Scenario What happens Revenue trend Margin trend
Competitive tender wins by low-cost suppliers Price resets downward Stable to down Down
Tender consolidation (fewer winners) Sustained contracted volumes for compliant suppliers Flat Mixed
Supply interruptions Higher realized price during shortage periods Up short-term Up short-term, then normalizes
Hospital formulary restricts use Reduced share within respiratory protocols Down Down

Is AMINOPHYLLIN an R&D or lifecycle-growth investment case?

For most business contexts, aminophylline is not an obvious lifecycle growth asset because value creation typically depends on:

  • new chemical entities (not the case for aminophylline),
  • meaningful formulation innovation that changes clinical adoption at scale, or
  • new patented delivery systems.

In generic-dominated classes, the financial upside usually comes from execution-led differentiation:

  • manufacturing cost leadership,
  • reliable supply and contracting,
  • speed of regulatory access in target markets.

What should investors and R&D planners track?

Because the commercial outcome is driven by procurement and supply execution, the actionable KPI set differs from brand-heavy portfolios.

Watchlist indicators

  • Tender outcomes in key hospital clusters (winning bid pricing and contract duration)
  • Formulary status across major payer types and hospital systems
  • Supply continuity (fill rate, batch release performance)
  • Input cost exposure for xanthine derivatives and upstream chemical intermediates
  • Regulatory batch compliance metrics (deviation rate, recall risk, stability trending)

Key Takeaways

  • AMINOPHYLLIN is a mature, generic-driven market where pricing power is structurally limited by multi-supplier competition and tender procurement.
  • Revenue direction is primarily price-led, with volume tied to respiratory disease burden and hospital protocol adherence.
  • Financial performance is operationally determined: margin moves with tender wins, manufacturing cost structure, and supply reliability.
  • Upside is execution-driven, not innovation-driven, unless a market introduces adoption-changing patented formulation or delivery technology.

FAQs

1) What drives AMINOPHYLLIN demand most consistently?
Acute-care and chronic respiratory disease management patterns, with recurring inpatient use during exacerbations.

2) Why does AMINOPHYLLIN pricing tend to fall over time?
Generic competition and tender-based procurement compress realized prices as multiple suppliers offer therapeutic equivalence.

3) What supplier capabilities matter most for profitability?
Cost-efficient manufacturing, stable batch release, compliance, and logistics that support contract continuity.

4) Can shortages increase profits for AMINOPHYLLIN?
They can lift realized pricing temporarily, but generics often normalize once supply returns and competition re-enters.

5) Does AMINOPHYLLIN offer meaningful long-term growth from patents?
Typically no; value creation depends on operational excellence and any adoption-changing formulation enhancements rather than new patent-protected chemistry.


References

[1] World Health Organization. WHO Model List of Essential Medicines. WHO. https://www.who.int/teams/priority-health-care/essential-medicines/
[2] U.S. Food and Drug Administration. Drugs@FDA. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Medicines Agency. Human medicines: EPAR and product information. EMA. https://www.ema.europa.eu/en/medicines

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