You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

PROCTOFOAM HC Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for PROCTOFOAM HC?
  • What are the global sales for PROCTOFOAM HC?
  • What is Average Wholesale Price for PROCTOFOAM HC?
Drug patent expirations by year for PROCTOFOAM HC
Recent Clinical Trials for PROCTOFOAM HC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Hospital for Sick Children
Duchesnay Inc.

See all PROCTOFOAM HC clinical trials

Pharmacology for PROCTOFOAM HC

US Patents and Regulatory Information for PROCTOFOAM HC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp PROCTOFOAM HC hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086195-001 Approved Prior to Jan 1, 1982 BX RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PROCTOFOAM HC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Proctofoam-HC

Introduction

Proctofoam-HC, a rectal aerosol foam containing hydrocortisone acetate and pramoxine hydrochloride, is a significant player in the market for anorectal care products. This article delves into the market dynamics and financial trajectory of Proctofoam-HC, highlighting its usage, market presence, and financial aspects.

Product Overview

Proctofoam-HC is a combination of a corticosteroid (hydrocortisone acetate) and an anesthetic (pramoxine hydrochloride), designed to relieve inflammation, itching, pain, and swelling associated with hemorrhoids, proctitis, cryptitis, fissures, and other anorectal conditions[2][3][4].

Market Presence

Proctofoam-HC is widely available in Canadian pharmacies and is covered by most private insurers and public insurance plans in several provinces and territories, including British Columbia, Alberta, New Brunswick, Nova Scotia, Newfoundland/Labrador, and the Yukon. It is also covered by the First Nations and Inuit Non-Insured Health Benefits Program and the Interim Federal Health Program for refugees[1].

Supply Chain and Availability

After a temporary drug shortage due to a disruption in the manufacturing process, Proctofoam-HC was reinstated in the Canadian market in August 2020. This reinstatement was a result of the hard work by Duchesnay Inc., the specialty pharmaceutical company behind the product[1].

Clinical Use and Indications

Proctofoam-HC is indicated for the temporary relief of anorectal inflammation, pruritus, pain, and swelling. It is applied topically to the affected area, typically 3 to 4 times a day, or as directed by a healthcare professional. The product is known for its anti-inflammatory, anti-pruritic, and vasoconstrictive properties, making it effective in soothing and lubricating the mucosa[2][3][4].

Side Effects and Safety Profile

While generally well-tolerated, Proctofoam-HC can cause side effects such as burning, itching, irritation, dryness, and skin thinning. It is contraindicated in patients with a history of hypersensitivity to any of its components. Special care is needed when using this product in pediatric and geriatric patients[2][3][4].

Market Demand and Competition

The demand for anorectal care products is driven by the prevalence of conditions such as hemorrhoids, proctitis, and anal fissures. Proctofoam-HC competes with other topical corticosteroids and anesthetics in the market. Its unique combination of hydrocortisone acetate and pramoxine hydrochloride sets it apart, making it a preferred choice for many healthcare providers and patients[2][3].

Financial Performance

The financial performance of Proctofoam-HC is influenced by several factors, including market demand, competition, and insurance coverage. The reinstatement of the product in the Canadian market after a temporary shortage likely had a positive impact on sales. Duchesnay Inc.'s broadened portfolio and commitment to women's health and other therapeutic areas also contribute to the overall financial health of the company.

Revenue Streams

Revenue for Proctofoam-HC comes from sales through pharmacies and wholesalers. The product's coverage by various insurance plans enhances its market accessibility and contributes to its revenue. Additionally, the company's expansion into other therapeutic areas helps diversify its revenue streams[1].

Challenges and Opportunities

One of the significant challenges faced by Proctofoam-HC was the temporary drug shortage, which impacted its availability and sales. However, the resolution of this issue and the product's reinstatement in the market presented an opportunity for the company to regain market share and customer trust.

Clinical Trials and Research

Clinical trials have demonstrated the efficacy and safety of Proctofoam-HC. For example, a clinical trial involving postpartum patients who underwent episiotomies showed rapid healing with minimal adverse reactions[4].

Regulatory Environment

Proctofoam-HC must comply with regulatory requirements, including those related to manufacturing, labeling, and safety. The product monograph provides detailed information on contraindications, warnings, precautions, adverse reactions, interactions, and dosing, ensuring compliance with regulatory standards[1][4].

Consumer and Healthcare Provider Perception

Proctofoam-HC is perceived positively by both consumers and healthcare providers due to its effectiveness in relieving anorectal symptoms. The product's ease of use and the presence of both anti-inflammatory and anesthetic components enhance its appeal.

Future Outlook

The future outlook for Proctofoam-HC appears promising, given its reinstatement in the market and the ongoing demand for effective anorectal care products. Duchesnay Inc.'s commitment to research and development, as well as its expanded portfolio, position the company for continued growth and success.

Key Takeaways

  • Market Presence: Widely available in Canadian pharmacies and covered by various insurance plans.
  • Clinical Use: Effective in relieving anorectal inflammation, pruritus, pain, and swelling.
  • Financial Performance: Influenced by market demand, competition, and insurance coverage.
  • Challenges and Opportunities: Overcame temporary drug shortage; opportunities in diversified revenue streams.
  • Regulatory Compliance: Adheres to strict regulatory requirements.
  • Future Outlook: Promising due to reinstatement and ongoing demand.

Frequently Asked Questions (FAQs)

Q: What are the active ingredients in Proctofoam-HC? A: The active ingredients are hydrocortisone acetate and pramoxine hydrochloride[2][3][4].

Q: What conditions is Proctofoam-HC used to treat? A: It is used to treat hemorrhoids, proctitis, cryptitis, fissures, and other anorectal conditions[2][3][4].

Q: How is Proctofoam-HC applied? A: It is applied topically to the affected area, typically 3 to 4 times a day, or as directed by a healthcare professional[2][3][4].

Q: Is Proctofoam-HC covered by insurance? A: Yes, it is covered by most private insurers and public insurance plans in several Canadian provinces and territories[1].

Q: What are the common side effects of Proctofoam-HC? A: Common side effects include burning, itching, irritation, and dryness[2][3][4].

Cited Sources:

  1. Canada Newswire - Proctofoam-HC® Back in Canadian Pharmacies
  2. Cleveland Clinic - Hydrocortisone; Pramoxine Rectal Aerosol Foam
  3. RxList - Proctofoam HC (Hydrocortisone and Pramoxine)
  4. Health Canada - Proctofoam-HC Product Monograph

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.