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Last Updated: March 15, 2025

PROLOPRIM Drug Patent Profile


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Which patents cover Proloprim, and when can generic versions of Proloprim launch?

Proloprim is a drug marketed by Monarch Pharms and is included in one NDA.

The generic ingredient in PROLOPRIM is trimethoprim. There are thirty-four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the trimethoprim profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Proloprim

A generic version of PROLOPRIM was approved as trimethoprim by DR REDDYS LABS SA on July 30th, 1982.

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Summary for PROLOPRIM
Drug patent expirations by year for PROLOPRIM
Recent Clinical Trials for PROLOPRIM

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SponsorPhase
University of SulaimaniN/A

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US Patents and Regulatory Information for PROLOPRIM

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Monarch Pharms PROLOPRIM trimethoprim TABLET;ORAL 017943-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Monarch Pharms PROLOPRIM trimethoprim TABLET;ORAL 017943-003 Jul 14, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Proloprim

Introduction

Proloprim, known generically as trimethoprim, is an antibiotic used primarily to treat urinary tract infections and other bacterial infections. To understand the market dynamics and financial trajectory of Proloprim, it is essential to delve into various aspects including market trends, competition, regulatory environment, and patient demographics.

Market Growth and Trends

The global market for antibiotics, including drugs like Proloprim, is influenced by several key factors. The increasing prevalence of bacterial infections and the rising demand for effective treatments drive market growth. Here are some critical trends:

Increasing Demand for Antibiotics

The global demand for antibiotics is on the rise due to the increasing incidence of bacterial infections. This trend is particularly pronounced in regions with high populations and limited access to advanced healthcare, where bacterial infections are more common[3].

HIV and Immunocompromised Patients

Patients with HIV/AIDS are more susceptible to opportunistic infections such as Pneumocystis carinii pneumonia (PCP), for which trimethoprim is often used in combination with sulfamethoxazole. The global HIV prevalence, estimated at 38 million people in 2019, contributes significantly to the demand for such treatments[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. Approvals, patent expirations, and new policies can significantly impact the market. For instance, the expiration of patents for branded drugs can lead to the entry of generic versions, affecting market share and pricing[3].

Market Segmentation

Understanding the market segmentation helps in identifying the target audience and distribution channels.

Treatment Segmentation

Proloprim is part of the broader urinary anti-infectives market. The market is segmented based on treatments such as trimethoprim, nitrofurantoin, and others. Trimethoprim, being a folic acid antagonist, is specifically used for treating bacterial infections[2].

Route of Administration

The route of administration for Proloprim includes oral and parenteral routes. Oral administration is more common due to its ease of use and patient compliance[2].

End-Users

The end-users for Proloprim include clinics, hospitals, and other healthcare facilities. The distribution channels include direct tender, hospital pharmacy, retail pharmacy, online pharmacy, and others[1].

Financial Trajectory

The financial trajectory of Proloprim is influenced by several factors including market size, growth rate, and competition.

Market Size and Growth Rate

The global Pneumocystis carinii pneumonia (PCP) market, which includes treatments like Proloprim, is expected to grow at a CAGR of 3.75% from 2021 to 2028. This growth is driven by increasing healthcare expenditure, government support, and the presence of pipeline products[1].

Prescription Drug Expenditures

Overall prescription drug spending is expected to rise by 10.0% to 12.0% in 2024, with a significant increase anticipated in clinics and hospitals. This trend indicates a growing financial investment in pharmaceuticals, which can positively impact the sales of Proloprim[3].

Competition and Generic Equivalents

The Proloprim brand name has been discontinued in the U.S., but generic versions of trimethoprim are available. This shift to generic equivalents can affect the pricing and market share of the drug. Generic competition often leads to reduced prices, making the drug more accessible but potentially reducing revenue for the original brand[2][5].

Side Effects and Precautions

While Proloprim is effective, it comes with several side effects and precautions that can impact its market dynamics.

Common Side Effects

Side effects such as skin rash, diarrhea, nausea, and vomiting can affect patient compliance and satisfaction. Severe side effects, though rare, include blood problems and allergic reactions, which require immediate medical attention[2][5].

Precautions

Patients taking Proloprim need regular check-ups to monitor for unwanted effects. The drug can cause anemia, and patients may need to take folic acid supplements. Dental care and hygiene are also critical during treatment to avoid complications[2].

Geographic Distribution

The market for Proloprim varies geographically, with different regions contributing differently to the overall market.

North America and Europe

North America and Europe account for significant market shares due to high healthcare expenditure and advanced distribution networks. These regions are expected to continue driving the market growth[1].

Asia Pacific

The Asia Pacific region is expected to see substantial growth due to increasing cases of HIV and growing investments in drug manufacturing capabilities. This region presents a lucrative opportunity for the market expansion of Proloprim[1].

Patient Epidemiology

Understanding patient demographics is crucial for market analysis.

HIV Prevalence

The global HIV prevalence is a significant factor in the demand for Proloprim. Patients with HIV are more susceptible to PCP and other opportunistic infections, driving the need for effective treatments like trimethoprim[1].

Urinary Tract Infections

The incidence of urinary tract infections (UTIs) also contributes to the demand for Proloprim. Studies have shown an increase in UTI prescriptions over the years, particularly in women[4].

Key Takeaways

  • Market Growth: The market for Proloprim is expected to grow at a CAGR of 3.75% from 2021 to 2028, driven by increasing healthcare expenditure and government support.
  • Competition: The presence of generic equivalents affects the pricing and market share of Proloprim.
  • Geographic Distribution: North America and Europe are significant markets, while the Asia Pacific region is expected to grow substantially.
  • Patient Demographics: HIV prevalence and the incidence of UTIs are key drivers of demand for Proloprim.
  • Side Effects and Precautions: Regular monitoring and precautions are necessary to manage side effects and ensure patient safety.

FAQs

What is Proloprim used for?

Proloprim, known generically as trimethoprim, is used to treat bacterial infections, particularly urinary tract infections and Pneumocystis carinii pneumonia (PCP)[2].

Why has the Proloprim brand name been discontinued?

The Proloprim brand name has been discontinued in the U.S., but generic versions of trimethoprim are available and approved by the FDA[2][5].

What are the common side effects of Proloprim?

Common side effects include skin rash, diarrhea, nausea, and vomiting. Severe side effects can include blood problems and allergic reactions[2][5].

How does the global HIV prevalence impact the market for Proloprim?

The global HIV prevalence drives the demand for Proloprim, as patients with HIV are more susceptible to opportunistic infections like PCP[1].

What is the expected growth rate of the market for Proloprim?

The market for Proloprim is expected to grow at a CAGR of 3.75% from 2021 to 2028[1].

Sources

  1. Global Pneumocystis Carinii Pneumonia (PCP) Market - Data Bridge Market Research
  2. Proloprim Advanced Patient Information - Drugs.com
  3. National trends in prescription drug expenditures and projections for 2024 - PubMed
  4. Trends of prescribing antimicrobial drugs for urinary tract infections - BMJ Open
  5. Proloprim: Indications, Side Effects, Warnings - Drugs.com

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