Caverject Patent Expiration

Caverject is a drug owned by Pfizer Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 21, 2015. Details of Caverject's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5741523 Stabilized prostaglandin E1
Apr, 2015

(11 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Caverject is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Caverject's family patents as well as insights into ongoing legal events on those patents.

Caverject's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Caverject:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer University Hospital, Rouen NA RECRUITING
(May 1, 2026)
PHASE3
A Single-Arm, Dose Escalation of an Intraurethral Alprostadil Paste for Erectile Dysfunction Ryan Flannigan, MD NA RECRUITING
(May 1, 2026)
PHASE2




Generic Launch

Generic Release Date:

Caverject's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 21, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Caverject Generic API suppliers:

Alprostadil is the generic name for the brand Caverject. 2 different companies have already filed for the generic of Caverject, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Caverject's generic

Alternative Brands for Caverject

There are several other brand drugs using the same active ingredient (Alprostadil) as Caverject. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Pfizer
Caverject Impulse
Viatris
Muse


Apart from brand drugs containing the same ingredient, some generics have also been filed for Alprostadil, Caverject's active ingredient. Check the complete list of approved generic manufacturers for Caverject





About Caverject

Caverject is a drug owned by Pfizer Inc. Caverject uses Alprostadil as an active ingredient. Caverject was launched by Pfizer in 1996.

Approval Date:

Caverject was approved by FDA for market use on 27 June, 1996.

Active Ingredient:

Caverject uses Alprostadil as the active ingredient. Check out other Drugs and Companies using Alprostadil ingredient

Dosage:

Caverject is available in injectable form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.01MG/VIAL INJECTABLE Prescription INJECTION
0.02MG/VIAL INJECTABLE Prescription INJECTION
0.005MG/VIAL INJECTABLE Discontinued INJECTION
0.04MG/VIAL INJECTABLE Prescription INJECTION