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Last Updated: March 26, 2025

PREDNISONE INTENSOL Drug Patent Profile


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

Prednisone Intensol is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in PREDNISONE INTENSOL is prednisone. There are sixteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Prednisone Intensol

A generic version of PREDNISONE INTENSOL was approved as prednisone by WATSON LABS on December 31st, 1969.

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Recent Clinical Trials for PREDNISONE INTENSOL

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SponsorPhase
Mamta ParikhPhase 2
Children's Oncology GroupPhase 2
Mayo ClinicPhase 2

See all PREDNISONE INTENSOL clinical trials

Pharmacology for PREDNISONE INTENSOL

US Patents and Regulatory Information for PREDNISONE INTENSOL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hikma PREDNISONE INTENSOL prednisone SOLUTION;ORAL 088810-001 Feb 20, 1985 RX Yes Yes ⤷  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 1 of 1 entries

Market Dynamics and Financial Trajectory for Prednisone Intensol

Introduction

Prednisone Intensol, a concentrated oral liquid solution of prednisone, is a widely used glucocorticoid for treating various inflammatory and immune-related conditions. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, healthcare providers, and patients alike.

Market Overview

Generic vs. Brand-Name Drugs

Prednisone Intensol is available as both a generic and a brand-name drug. The generic version is considered as safe and effective as the brand-name version but tends to be more cost-effective. This dual availability impacts the market dynamics, as patients and healthcare providers often opt for the generic version to reduce costs[2].

Forms and Strengths

Prednisone Intensol is available in a concentrated oral liquid solution, containing 5 mg of prednisone per mL, and comes in 120-mL and 500-mL bottles. This formulation is distinct from other forms like oral tablets and delayed-release tablets (e.g., Rayos), which can influence patient preference and prescribing patterns[2].

Indications and Usage

Broad Range of Conditions

Prednisone Intensol is indicated for a wide range of conditions, including immunosuppressive/endocrine, rheumatic, collagen, dermatologic, allergic states, ophthalmic, respiratory, hematologic, neoplastic, edematous, and gastrointestinal disorders. This broad applicability ensures a steady demand for the drug[3].

Mechanism of Action

The drug works by suppressing the immune system and reducing inflammation, which is crucial for managing chronic and acute conditions. Its effectiveness in various disease states contributes to its market stability[3].

Pricing and Cost Factors

Variability in Cost

The cost of Prednisone Intensol can vary significantly based on several factors, including the patient's treatment plan, insurance coverage, and the pharmacy used. Generic versions are generally cheaper than brand-name counterparts, but prices can fluctuate[2].

Insurance Coverage and Pharmacy Impact

Insurance coverage plays a critical role in determining the cost to the patient. Some insurance plans may only cover specific forms or strengths of prednisone, influencing the financial trajectory. Additionally, the choice of pharmacy can affect the final cost, with some pharmacies offering better prices or discounts[2].

Coupons and Discounts

To mitigate costs, patients can use coupons and discount programs, such as Optum Perks, which can significantly reduce the out-of-pocket expenses for Prednisone Intensol[2].

Financial Trajectory

Revenue Streams

The revenue generated from Prednisone Intensol comes from both prescription sales and insurance reimbursements. Given its widespread use and the chronic nature of many conditions it treats, the drug maintains a stable revenue stream.

Market Competition

The market for prednisone is competitive, with multiple generic and brand-name options available. However, Prednisone Intensol's unique formulation and concentrated solution offer a competitive edge, particularly for patients who have difficulty swallowing tablets[2].

Long-Term Cost Management

Patients and healthcare providers often seek ways to manage long-term costs. Strategies such as obtaining a 90-day supply of the drug, if approved by insurance, can reduce the number of pharmacy visits and lower overall costs[2].

Adverse Effects and Safety Considerations

Impact on Market Dynamics

The adverse effects of prednisone, such as hyperglycemia, insomnia, and osteoporosis, especially with high doses or prolonged use, can influence market dynamics. Patients and healthcare providers must weigh the benefits against the risks, which can affect prescribing patterns and patient compliance[3].

Monitoring and Adjustments

The need for constant monitoring and potential dosage adjustments due to adverse effects or changes in clinical status can impact the financial trajectory. Frequent monitoring may increase healthcare costs, but it is essential for maintaining patient safety and efficacy[5].

Regulatory and Compliance Aspects

FDA Approval and Guidelines

Prednisone Intensol is FDA-approved, and its use is guided by strict regulatory guidelines. Compliance with these guidelines is crucial for maintaining market approval and ensuring patient safety. Any changes in regulatory requirements can impact the financial trajectory of the drug[3].

Contraindications and Warnings

Systemic fungal infections and known hypersensitivity to components are contraindications for Prednisone Intensol. Warnings about immunosuppression, increased risk of infections, and reactivation of latent infections (e.g., tuberculosis, varicella) must be carefully managed, which can influence prescribing decisions and market dynamics[5].

Key Takeaways

  • Broad Applicability: Prednisone Intensol is used for a wide range of conditions, ensuring steady demand.
  • Cost Variability: Prices vary based on treatment plans, insurance, and pharmacies.
  • Generic and Brand Options: Availability of both generic and brand-name versions impacts market dynamics.
  • Adverse Effects: Monitoring and managing adverse effects are crucial for patient safety and compliance.
  • Regulatory Compliance: Adherence to FDA guidelines is essential for market approval and patient safety.

FAQs

Q: What are the common forms and strengths of Prednisone Intensol?

A: Prednisone Intensol is available as a concentrated oral liquid solution containing 5 mg of prednisone per mL, in 120-mL and 500-mL bottles[2].

Q: How does the cost of Prednisone Intensol vary?

A: The cost can vary based on the treatment plan, insurance coverage, and the pharmacy used. Generic versions are generally cheaper than brand-name counterparts[2].

Q: What are some strategies to reduce the long-term cost of Prednisone Intensol?

A: Strategies include obtaining a 90-day supply if approved by insurance, using coupons and discount programs, and choosing pharmacies that offer better prices[2].

Q: What are the primary adverse effects of Prednisone Intensol?

A: The primary adverse effects include hyperglycemia, insomnia, increased appetite, hypertension, osteoporosis, edema, adrenal suppression, cataracts, and delayed wound healing[3].

Q: Are there any specific regulatory considerations for Prednisone Intensol?

A: Yes, Prednisone Intensol is subject to FDA approval and guidelines. It is contraindicated in systemic fungal infections and known hypersensitivity to components, and warnings include immunosuppression and increased risk of infections[5].

Sources

  1. DailyMed: Prednisone Intensol™ Oral Solution (Concentrate) - DailyMed.
  2. MedicalNewsToday: Prednisone cost 2024: Coupons and more.
  3. StatPearls - NCBI: Prednisone.
  4. Boehringer Ingelheim: Prednisone Tablets Oral Solution and Intensol.
  5. DailyMed: Prednisone Intensol solution, concentrate.

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