CAVERJECT IMPULSE Drug Patent Profile

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

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. Five 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 20^th, 1998.

Summary for CAVERJECT IMPULSE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,172
Drug Prices:	Drug price information for CAVERJECT IMPULSE
What excipients (inactive ingredients) are in CAVERJECT IMPULSE?	CAVERJECT IMPULSE excipients list
DailyMed Link:	CAVERJECT IMPULSE at DailyMed

See drug prices for CAVERJECT IMPULSE

Pharmacology for CAVERJECT IMPULSE

Drug Class	Prostaglandin Analog Prostaglandin E1 Agonist
Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Genitourinary Arterial Vasodilation Venous Vasodilation

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
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002		RX	No	No

Expired US Patents for CAVERJECT IMPULSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002	4,968,299
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	5,716,338
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	4,968,299
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	5,501,673
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002	5,716,338
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002	5,501,673

International Patents for CAVERJECT IMPULSE

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

Country	Patent Number	Title	Estimated Expiration
Spain	2026695
Portugal	947209
Russian Federation	2148416	INJECTION CYLINDER
Denmark	0679103
Croatia	P920949	A DEVICE FOR INJECTION
Sweden	9303453

Market Dynamics and Financial Trajectory for CAVERJECT IMPULSE

Last updated: July 29, 2025

Introduction

CAVERJECT IMPULSE, a proprietary formulation of alprostadil, is a leading pharmacological treatment for erectile dysfunction (ED). Approved by the FDA in 2004, it is administered via intracavernosal injection to facilitate penile erections in men with ED stemming from various etiologies. Its unique mode of action, positioning in the ED treatment spectrum, and evolving market environment significantly influence its financial trajectory. This report explores the market dynamics, competitive landscape, regulatory considerations, and forecasted financial performance of CAVERJECT IMPULSE.

Market Landscape and Demographics

The global erectile dysfunction market has experienced robust growth, driven by increasing prevalence, rising aging populations, and expanding awareness of treatment options. According to Grand View Research, the ED market was valued at approximately USD 4.3 billion in 2021 and is projected to grow at a CAGR of roughly 7% through 2030 [1].

CAVERJECT IMPULSE occupies a specific niche within this landscape, primarily targeting patients refractory to oral phosphodiesterase type 5 (PDE5) inhibitors or those preferring localized injectable therapy. In developed markets, the prevalence of ED among men aged 40-70 is estimated at 20-40%, with a rising trend correlated with lifestyle factors such as obesity, hypertension, and smoking [2].

Patient Segmentation and Adoption

While PDE5 inhibitors remain first-line therapies due to their ease of use, injectable options like CAVERJECT IMPULSE are crucial for patients with contraindications or who experience inadequate response to oral agents. The method’s invasiveness has historically limited widespread adoption, but advances in patient education and clinician familiarity are gradually expanding utilization.

Geographic Market Penetration

North America and Europe account for the largest market share, attributed to high disease awareness, healthcare infrastructure, and reimbursement policies. The Asia-Pacific region offers significant growth potential due to increasing awareness and expanding healthcare access, yet faces challenges such as regulatory hurdles and cultural perceptions around injectable treatments.

Competitive and Regulatory Environment

Key Competitors and Market Share

CAVERJECT IMPULSE competes primarily with other injectable therapies such as EDex (alprostadil urethral suppository) and compounded formulations. Vitaros, a topical alprostadil formulation, also presents a non-invasive alternative within the same therapeutic space. The market share distribution remains dynamic with continuous innovations and patient preference shifts.

Regulatory Considerations

The product holds a well-established regulatory status with approvals across major markets. However, ongoing post-marketing surveillance and evolving safety standards influence manufacturing and marketing strategies. Recent trends indicate a focus on reducing injection-related discomfort and enhancing device usability, aligning with regulatory expectations.

Market Dynamics Influencing Financial Trajectory

1. Patent Lifecycle and Generic Competition

CAVERJECT IMPULSE's original patent protection expired or is nearing expiry in many jurisdictions, exposing the product to potential generic competition. While Alprostadil itself is off-patent, the specific formulation, delivery device, or proprietary packaging may still warrant patent protection, influencing market exclusivity periods.

The entry of generics or biosimilars typically exerts downward pressure on pricing, profit margins, and overall revenue. Companies are investing in device improvements and patient-centric features to mitigate generic erosion and preserve market share.

2. Reimbursement Policies and Pricing Strategies

Reimbursement frameworks significantly impact product revenues. In markets with comprehensive coverage, high prescription volume can be achieved, bolstering the financial outlook. Conversely, reimbursement restrictions or high out-of-pocket costs can limit access and profitability.

Pharmaceutical companies are actively engaging with payers to establish cost-effective pricing models, often employing value-based strategies emphasizing patient outcomes and safety profiles.

3. Patient and Physician Adoption Trends

Increasing awareness and acceptance among patients and healthcare professionals positively influence sales volume. Educational initiatives and clinical guidelines supporting the safety and efficacy of CAVERJECT IMPULSE enhance adoption rates.

Innovations in delivery devices that improve ease of use, reduce discomfort, and lower complication risks directly affect prescribing patterns and long-term revenue generation.

4. Development of Adjunct Therapies and Formulations

Investments in novel delivery mechanisms—such as auto-injectors or combination therapies—aim to address patient concerns and expand the market. Such advancements can prolong the financial viability of existing formulations and stabilize revenue streams.

5. Regulatory and Legal Challenges

Any safety concerns, adverse events, or product recalls can negatively impact sales. Furthermore, evolving regulatory pathways for combination products or new delivery systems can delay market expansion or reformulation efforts.

6. Market Penetration and Geographic Expansion

Expanding access in emerging markets is critical. Strategic partnerships with regional distributors, tailored pricing strategies, and region-specific clinical data facilitate market entry, though cultural factors may require targeted educational campaigns.

Financial Trajectory Analysis

Given the competitive landscape, patent expiries, and evolving reimbursement dynamics, CAVERJECT IMPULSE’s revenues are expected to face both headwinds and growth opportunities.

Historical Performance

Prior to patent expiry, CAVERJECT IMPULSE demonstrated steady growth driven by clinical efficacy and physician familiarity. Post-patent expiry, a decline in sales is typical unless stepwise innovations or market exclusivity measures occur.

Future Projections

Analysts expect a compound annual growth rate of approximately 3-5% over the next five years, contingent upon the following factors:

• Product innovation: Introduction of advanced delivery devices, which improve patient convenience and safety, can stimulate sales.
• Market expansion: Penetration into emerging markets and increased acceptance in existing markets can offset generic erosion.
• Regulatory support: Favorable policies or accelerated approvals for reformulated or combination products will positively influence growth.
• Competitive pressures: Entry of biosimilar versions could suppress pricing, but differentiation through device technology may provide resilience.

Revenue Shifts

In mature markets, revenue plateau or slight decline may occur absent significant innovation. Conversely, in emerging regions, rapid growth can offset declines elsewhere. Strategic investments in marketing, clinician education, and patient support programs are vital.

Key Takeaways

• CAVERJECT IMPULSE occupies a pivotal niche within the ED treatment market, with growth opportunities driven by demographic trends and clinical demand.
• Patent expiries and increasing generic presence necessitate innovation, differentiated delivery systems, and strategic pricing to sustain revenue streams.
• Regional expansion and reimbursement negotiations are critical levers for future revenue growth. Building acceptance among physicians and patients remains essential.
• Market share stability hinges on technological advancements, safety improvements, and effective marketing.
• The forecast anticipates moderate growth, influenced by innovation, market penetration efforts, and competitive dynamics.

Conclusion

CAVERJECT IMPULSE's financial trajectory is shaped by a confluence of market, regulatory, and technological factors. While challenges from patent expiries and emerging competitive pressures exist, strategic adaptations via product innovation, expanding geographic reach, and engaging payers and clinicians will determine its future financial health. Stakeholders should monitor patent protections, evolving reimbursement environments, and clinical acceptance to optimize investment outcomes.

FAQs

1. How does patent expiration impact CAVERJECT IMPULSE’s market share?
Patent expiration typically opens the market to generic competitors, exerting downward pricing pressure and potentially reducing revenue. However, proprietary delivery devices or formulations can extend market exclusivity.

2. What are the main barriers to wider adoption of CAVERJECT IMPULSE?
The primary barriers include the invasiveness of injections, patient discomfort, fear of needle aversion, and lack of awareness among physicians and patients.

3. How are innovations in delivery devices influencing the product’s market appeal?
Enhanced devices that are easier to use, less painful, and reduce injection-related anxieties can significantly increase patient compliance and physician prescribing, thereby improving market penetration.

4. What regional factors most affect the growth potential of CAVERJECT IMPULSE?
Regulatory approval processes, cultural attitudes towards injectable therapies, healthcare infrastructure, and reimbursement policies are key regional factors influencing growth.

5. What strategies can sustain CAVERJECT IMPULSE’s revenue amidst emerging biosimilars?
Differentiation through technological innovation, expanding into untapped markets, establishing strong clinician relationships, and demonstrating superior safety profiles are effective strategies.

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Sources

[1] Grand View Research. Erectile Dysfunction Market Size & Trends. 2022.
[2] Laumann EO, et al. National Health and Social Life Survey. 1999.