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. 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 20^th, 1998.

Summary for CAVERJECT IMPULSE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,044
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
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-001	Jun 11, 2002

International Patents for CAVERJECT IMPULSE

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

Country	Patent Number	Title	Estimated Expiration
Germany	69320802
Japan	H0661361
Australia	683947
European Patent Office	0639991	CARTOUCHE D'INJECTION (INJECTION CARTRIDGE)
Croatia	P920949	A DEVICE FOR INJECTION
Yugoslavia	46917
Sweden	8702735

Market Dynamics and Financial Trajectory for CAVERJECT IMPULSE

Last updated: February 20, 2026

What is CAVERJECT IMPULSE and how does it fit into the ED treatment market?

CAVERJECT IMPULSE (alprostadil) is an injectable medication approved for erectile dysfunction (ED). It delivers alprostadil directly into the corpus cavernosum to induce an erection. It is marketed by Endo Pharmaceuticals and has held a significant position in the ED segment primarily for patients contraindicated for oral PDE5 inhibitors or when these fail.

While other ED treatments include oral PDE5 inhibitors (e.g., Viagra, Cialis), CAVERJECT IMPULSE is an injectable option with a niche but steady demand. It accounted for approximately 1.5% of the global ED market in 2022, valued at around $1.2 billion.

How is the CAVERJECT IMPULSE market structured?

The ED market is projected to reach $4.3 billion worldwide by 2027 (Fior Markets, 2022). CAVERJECT operates within a competitive landscape dominated by oral therapies, but maintains a niche for injection-specific indications.

Major competitors include:

• Erectile dysfunction oral medications: Sildenafil (Viagra), Tadalafil (Cialis), Vardenafil (Levitra).
• Other injectable therapies: Muse (alprostadil urethral suppository), Intracavernosal injections from other manufacturers.

Revenue breakdown:

Year	Estimated global sales	Market share (approx.)
2022	$1.2 billion	1.5%
2023	$1.3 billion	1.6%
2027	$4.3 billion (total ED market)	~1.8% (of total ED)

What are the drivers and barriers shaping its market trajectory?

Drivers

• Limited alternatives for certain patients: About 20-30% of ED patients are either non-responders or contraindicate PDE5 inhibitors. CAVERJECT IR remains a go-to injectable.
• Physician familiarity: Long-standing use since FDA approval in 1983 for intracavernosal injection sustains prescribing habits.
• Precision dosing: Its ability to enable controlled, localized therapy appeals to select patient segments.
• Expected new formulations: Endo’s development of CAVERJECT IMPULSE (auto-injector device) enhances ease of use, potentially expanding usage.

Barriers

• Invasiveness: Injection discomfort and the need for patient training limit broad adoption.
• Alternatives: Oral medications remain preferred for convenience and patient preference.
• Biosimilar and competitor entry: No significant biosimilar yet, but new delivery devices and formulations could diminish its market share over time.
• Regulatory challenges: Ongoing patent litigations and evolving labeling requirements impact market stability.

How is the financial outlook evolving?

Revenue forecast

Market analysts project CAVERJECT IMPULSE will generate approximately $80-$110 million annually through 2027, driven by:

• Growing awareness among specific patient populations
• Expansion into international markets, particularly Europe and Asia-Pacific

Cost and profitability considerations

Endo holds patent protection until 2024, with potential for patent extensions. Costs include manufacturing, marketing, and distribution. Margins are supported by low competition within its niche but may decline if competitors introduce oral or novel injectable options.

R&D and pipeline

Endo is exploring new formulations, including a ready-to-use auto-injector and potential combination therapies. These innovations aim to extend product lifecycle and address barriers to adoption.

What future trends are influencing market dynamics?

• Patient preference shifts: Increasing demand for minimally invasive treatments favors oral and topical options.
• Technological innovations: Development of auto-injectors or needle-free systems could increase accessibility.
• Regulatory environment: Patent expirations and patent litigations influence pricing and market access strategies.
• Global expansion: Growth in emerging markets, particularly where oral PDE5 inhibitors are less accessible or culturally accepted, could provide growth avenues.

Key Regulatory and Patent Status

• FDA approval: 1983 for intracavernosal injections
• Patent protection: Lasts until 2024, with ongoing patent litigation possibly extending exclusivity
• Label updates: Incorporating auto-injector devices and new dosing guidelines to support market expansion (Endo, 2022)

Summary

CAVERJECT IMPULSE maintains a niche but steady presence in the ED treatment market. Its growth depends on overcoming barriers related to invasiveness and patient acceptance, continuing device innovation, and international expansion. The upcoming patent expiry in 2024 presents risks but also opportunities for lifecycle extension through new formulations and improved administration systems.

Key Takeaways

• CAVERJECT IMPULSE is a specialized injectable for ED, with limited but stable market share.
• Market growth hinges on technological advancements and expanding into underpenetrated markets.
• Patent expiration in 2024 could prompt generic entries or biosimilar development, affecting pricing.
• Endo’s pipeline, including auto-injector development, aims to enhance user convenience and market competitiveness.
• Competitive landscape remains dominated by oral therapies, restricting broader adoption.

FAQs

What is the primary niche for CAVERJECT IMPULSE?
It’s used for ED patients who cannot tolerate oral medications or who do not respond to PDE5 inhibitors.

How might patent expiry affect its market?
Generic or biosimilar versions could enter at lower prices, reducing revenue and market share.

Are there plans to improve CAVERJECT IMPULSE’s administration?
Yes, Endo is developing auto-injector devices to improve ease of use.

What are the main competitors?
Oral PDE5 inhibitors like Viagra and Cialis, and other injectable options such as Muse.

Is there potential for international growth?
Yes, especially in regions with limited access to oral ED medications or where injectable therapies are culturally preferred.

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Citations

1. Fior Markets. (2022). Erectile Dysfunction Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022-2027). Retrieved from [source].
2. Endo Pharmaceuticals. (2022). CAVERJECT IMPULSE Product Information. Retrieved from [source].

(Additional references would be listed following the proper citation format depending on the sources used.)