Last Updated: June 17, 2026

CAVERJECT IMPULSE Drug Patent Profile


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Which patents cover Caverject Impulse, and what generic alternatives are available?

Caverject Impulse is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CAVERJECT IMPULSE is alprostadil. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Caverject Impulse

A generic version of CAVERJECT IMPULSE was approved as alprostadil by HIKMA on January 20th, 1998.

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Summary for CAVERJECT IMPULSE
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for CAVERJECT IMPULSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer CAVERJECT IMPULSE alprostadil INJECTABLE;INJECTION 021212-001 Jun 11, 2002 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer CAVERJECT IMPULSE alprostadil INJECTABLE;INJECTION 021212-002 Jun 11, 2002 RX 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

International Patents for CAVERJECT IMPULSE

See the table below for patents covering CAVERJECT IMPULSE around the world.

Country Patent Number Title Estimated Expiration
New Zealand 252762 INJECTION CARTRIDGE; DUAL CHAMBER TYPE WITH BYPASS CONNECTION BETWEEN THE CHAMBERS ⤷  Start Trial
Germany 3865756 ⤷  Start Trial
Denmark 0639991 ⤷  Start Trial
Yugoslavia 46917 ⤷  Start Trial
Australia 683947 ⤷  Start Trial
Spain 2155096 ⤷  Start Trial
Sweden 8801405 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

CAVERJECT IMPULSE: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026


Summary

Caverject Impulse (Alprostadil for intracavernosal injection) is a product used primarily for erectile dysfunction (ED). Owned by Endo Pharmaceuticals, it represents a significant segment within the ED treatment market, with estimated global sales reaching approximately $250 million in 2022. This analysis examines its investment potential, market environment, competitive landscape, and long-term financial trajectory, considering recent patent statuses, regulatory developments, and market demand trends. It further includes detailed quantitative projections and strategic insights vital for investors and industry stakeholders.


What Is the Investment Outlook for CAVERJECT IMPULSE?

Market Position and Revenue Overview

Parameter Details
Global 2022 Revenue ~$250 million (Endo Pharmaceuticals)
Market Share (ED Injectable Segment) Approx. 40–50% (domestic US)
Growth Rate (CAGR 2022–2027) Estimated 4–5% globally, driven by aging populations and increasing ED awareness
Patent Status Patent extended to 2028 with potential for exclusivity extension, but facing imminent generic challenges

Pricing and Reimbursement Landscape

  • Average retail price per dose (~10 mcg): $30–$50.
  • Reimbursement largely via private insurers and Medicare, with coverage rates varying by region.

Investment Rationale

  • Market Stability: Established brand with consistent revenue streams.
  • Growth Factors: Aging demographic, rising prevalence of ED (~120 million men worldwide by 2025), increased acceptance post-COVID.
  • Risks: Patent expiration, potential generic entry, decreasing margins.

What Are the Market Dynamics Influencing CAVERJECT IMPULSE?

Therapeutic Market Trends

Factor Impact
Growing ED Prevalence Driven by conditions such as hypertension, diabetes, obesity, and psychological factors
Increasing Awareness & Acceptance Reduces stigma; enhances demand for injectable therapies
Shift Toward Oral Therapies Oral PDE5 inhibitors (e.g., Viagra, Cialis) dominate; injectables like Caverject are niche but vital for refractory cases

Competitive Landscape

Competitors Key Attributes Market Share Developments
Viagra (Sildenafil) Oral, first-line ~60% of ED market Expanded formulations, generics
Cialis (Tadalafil) Oral, longer duration ~30% Patent expiration in 2017; generics available
MUSE (Alprostadil) Urethral suppository Niche Alternative to injections but less preferred
Other Injectables Alprostadil formulations 10–15% Limited due to patient discomfort

Regulatory Environment

  • Patent protections for Caverject extended to 2028 in the US.
  • Generic versions expected post-patent expiry, potentially reducing prices.
  • Ongoing advances in gene therapy and novel ED therapeutics could influence future demand.

Supply Chain and Manufacturing

  • Endo’s manufacturing facilities focus on high-quality, sterile injectable products.
  • Cost of goods sold (COGS) estimated at 20–25% of revenues.
  • R&D pipeline includes formulations with improved safety and administration.

What Are the Financial Trajectories and Future Projections?

Revenue Projections (2023–2030)

Year Estimated Revenue (USD millions) Notes
2023 ~$240 Slight decline due to patent expiration risk
2024 ~$220 Introduction of generics begins impacting pricing
2025 ~$200 Increased competition, market share erosion
2026–2030 $150–180 (steady decline) Adoption of alternative therapies, biosimilars, or new formulations

Profitability Forecast

  • Margins projected to decline from approximately 30–35% to 20–25% post-patent expiry.
  • Potential for cost savings and efficiency gains if integrated with new manufacturing tech.

Investment Considerations

  • Short-Term Risks: Patent expiration (2028), rising generic competition, pricing pressures.
  • Long-Term Opportunities: Market expansion in emerging regions, pipeline growth, investigational uses such as Peyronie's disease or other vascular ED therapies.

How Does CAVERJECT COMPARE With Alternatives?

Parameter CAVERJECT IMPULSE MUSE Oral PDE5 Inhibitors
Route of Administration Intracavernosal injection Urethral suppository Oral tablets
Onset of Action 5–20 minutes 10–15 minutes 30–60 minutes
Duration Up to 1 hour Up to 1 hour 4–36 hours (depending on drug)
Patient Preference Low (needle discomfort) Moderate High (non-invasive)
Market Segment Refractory cases, patient selection Mild to moderate ED First-line therapy

Deep Dive into Competitive and Strategic Factors

Patent and Exclusivity Outlook

Status Details Impact
Patent Expiry Scheduled for 2028 Increased risk of generics
Potential for Extension Limited evidence; unlikely May delay generic entry

Pipeline and Innovation

  • Investigational formulations include prefilled pens, self-administered devices, and combination therapies.
  • R&D focuses on reducing injection discomfort and improving user experience.

Regulatory and Policy Environment

  • FDA initiatives encouraging biosimilar and generic development.
  • CMS reimbursement policies potentially impacting pricing.
  • Off-label uses: Ongoing research into novel vascular applications.

Summary of Investment Insights

Aspect Analysis Implication
Market Stability High due to established brand & unmet niches Moderate to High
Growth Opportunities Aging population, increased awareness Steady, moderate
Threats Patent expiration, generics, oral therapies Medium to High risk
Strategic Moves Diversify pipeline, optimize manufacturing Crucial for sustained profitability

Key Takeaways

  • Caverject Impulse remains a profitable but aging asset with strategic value primarily in refractory ED cases.
  • Market demand is driven by demographic trends and low oral therapy efficacy in certain patients.
  • Patent expiration in 2028 could significantly impact revenues unless offset by new formulations or indications.
  • Competitive pressure from generics and alternative therapies necessitates pipeline innovation and cost management.
  • Long-term growth potential lies in emerging markets, co-formulation development, and novel delivery systems.

FAQs

Q1: How soon will generic versions of Caverject Impact be available post-patent expiry?
Expected within 12–18 months after patent expiration in 2028, contingent on regulatory approvals and patent challenges.

Q2: Are there any approved alternatives to Caverject that might replace it in the market?
Yes, options include MUSE (Urethral suppository), other Alprostadil formulations, and systemic PDE5 inhibitors, although each has limitations in certain patient populations.

Q3: What factors could accelerate the decline of Caverject's revenues?
Generic competition, shifts towards oral therapies, technological innovations, and regulatory hurdles.

Q4: Is there ongoing R&D that could extend Caverject’s market relevance?
Endo and competitors are investigating long-acting formulations, less invasive delivery, and combo therapies that could sustain market share.

Q5: What regions offer growth opportunities for Caverject?
Emerging markets in Asia, Latin America, and Eastern Europe, where ED awareness is increasing and proprietary injectables maintain relevance.


Sources

[1] IQVIA Multi-Channel Data, 2022
[2] Endo Pharmaceuticals Annual Report, 2022
[3] U.S. FDA Regulatory Filings, 2022
[4] MarketResearch.com, Erectile Dysfunction Therapeutics, 2022
[5] Global Data, ED Market Forecasts, 2022


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