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Last Updated: December 22, 2024

PREDSULFAIR Drug Patent Profile


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

Predsulfair is a drug marketed by Pharmafair and is included in three NDAs.

The generic ingredient in PREDSULFAIR is prednisolone acetate; sulfacetamide sodium. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone acetate; sulfacetamide sodium profile page.

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Summary for PREDSULFAIR
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 96
DailyMed Link:PREDSULFAIR at DailyMed
Drug patent expirations by year for PREDSULFAIR

US Patents and Regulatory Information for PREDSULFAIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair PREDSULFAIR prednisolone acetate; sulfacetamide sodium OINTMENT;OPHTHALMIC 088032-001 Apr 15, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmafair PREDSULFAIR prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088007-001 Apr 19, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmafair PREDSULFAIR II prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088837-001 Dec 24, 1985 DISCN No No ⤷  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

PREDSULFAIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prescription Drugs: A Case Study Approach

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including new drug approvals, patent expirations, market competition, and regulatory policies. This article will delve into the market dynamics and financial trajectory of prescription drugs, using the context provided by recent studies and data to illustrate key trends and projections.

Historical Patterns in Pharmaceutical Expenditures

Historically, pharmaceutical expenditures have shown significant growth. Between 2016 and 2021, prescription drug spending in the U.S. increased from $520 billion to $603 billion, a 16% rise[3].

Factors Influencing Future Spending

Several factors are crucial in predicting future spending on prescription drugs:

New Drug Approvals

New drug approvals significantly impact spending. For instance, in 2023, new drugs contributed a 4.2% increase to overall pharmaceutical expenditures[1].

Patent Expirations

Patent expirations lead to the introduction of generic and biosimilar drugs, which can reduce costs. However, the impact of generic competition varies, especially for drugs targeting small patient populations where generic entry may be limited[2].

Utilization and Price

Increases in drug utilization and prices are key drivers of expenditure growth. In clinics, increased utilization has driven spending, while in nonfederal hospitals, a drop in utilization has led to decreased expenditures despite modest contributions from price and new drugs[1].

Market Segments and Their Impact

Retail vs. Non-Retail Drugs

Retail drug expenditures represented about 70% of prescription drug spending, while non-retail drugs accounted for 30%. Non-retail drug spending grew faster, with a 25% increase between 2016 and 2021, driven primarily by greater utilization[3].

Specialty Drugs

Specialty drugs have seen a significant increase in spending, rising by 43% between 2016 and 2021 to a total of $301 billion. Despite a small increase in the number of prescriptions, the spending per prescription has been the primary driver of this growth[3].

Economic Implications of Precision Medicines

The shift towards precision medicines, such as those targeting small patient populations, has economic ramifications. These drugs often come with high prices due to their value to patients and the limited market size, which can deter generic competition[2].

Example: Kalydeco (Ivacaftor)

Kalydeco, a treatment for a subset of cystic fibrosis patients, illustrates this point. With a patient population of only 2,000 to 3,000 and a cost of several hundred thousand dollars per year, it is unlikely that additional firms will enter this market, maintaining high prices[2].

Generic Drug Industry Dynamics

Price and Competition

Generic drug prices decrease with the number of competitors but remain above long-run marginal costs until there are eight or more competitors. The timing of FDA approval and the sequence of entry can significantly affect the profits of generic drug manufacturers[4].

Market Size and Entry

The size of the market and expected rents influence the number of firms that enter the generic drug market. Firms are more likely to enter markets with greater expected profits, and early entrants often earn higher profits[4].

Projections for 2024

Overall Prescription Drug Spending

For 2024, overall prescription drug spending is expected to rise by 10.0% to 12.0%. In clinics, an increase of 11.0% to 13.0% is anticipated, while nonfederal hospitals are expected to see a 0% to 2.0% increase[1].

Key Drivers

Specialty, endocrine, and cancer drugs are expected to continue driving expenditures. New drug approvals and increased utilization in clinics will be significant factors in the growth of pharmaceutical spending[1].

Impact of Public Policy and Legislation

Regulatory Environment

Public policies and legislation can significantly impact the pharmaceutical market. For example, policies affecting patent protection, generic drug approvals, and pricing strategies can alter the financial trajectory of prescription drugs[2].

Example: Rebates and Competition

The use of rebates for high-cost drugs has been a strategy to manage costs, but it also affects market competition. Understanding these dynamics is crucial for predicting future spending trends[3].

Case Study: Semaglutide

Market Performance

Semaglutide, a top drug in 2023, exemplifies the impact of new drugs on market dynamics. Its success is driven by its therapeutic value and market demand, contributing to the overall growth in pharmaceutical expenditures[1].

Economic Impact

The economic impact of drugs like semaglutide includes high spending due to increased utilization and pricing. Such drugs often set precedents for future drug pricing and development strategies[1].

Key Takeaways

  • Growth Projections: Prescription drug spending is expected to rise by 10.0% to 12.0% in 2024.
  • Market Drivers: New drug approvals, increased utilization, and specialty drugs are key drivers of expenditure growth.
  • Generic Competition: Generic drug prices decrease with the number of competitors, but early entrants often earn higher profits.
  • Precision Medicines: Drugs targeting small patient populations come with high prices and limited generic competition.
  • Public Policy: Regulatory policies significantly impact the pharmaceutical market, affecting patent protection, generic approvals, and pricing strategies.

FAQs

Q: What are the main drivers of prescription drug spending growth in 2024?

A: The main drivers include new drug approvals, increased utilization, especially in clinics, and the continued growth in spending on specialty, endocrine, and cancer drugs.

Q: How does generic competition affect drug prices?

A: Generic drug prices decrease with the number of competitors but remain above long-run marginal costs until there are eight or more competitors.

Q: What is the impact of precision medicines on the pharmaceutical market?

A: Precision medicines often target small patient populations, leading to high prices and limited generic competition due to the small market size.

Q: How do public policies influence the pharmaceutical market?

A: Public policies can affect patent protection, generic drug approvals, and pricing strategies, thereby influencing the financial trajectory of prescription drugs.

Q: What are the projections for nonfederal hospital and clinic spending in 2024?

A: Nonfederal hospitals are expected to see a 0% to 2.0% increase, while clinics are anticipated to see an 11.0% to 13.0% increase in prescription drug spending.

Sources

  1. National trends in prescription drug expenditures and projections for 2024. PubMed.
  2. The Economics of Drug Development: Pricing and Innovation in a Changing Market. National Bureau of Economic Research.
  3. Trends in Prescription Drug Spending, 2016-2021. ASPE.
  4. Generic Drug Industry Dynamics. Federal Trade Commission.

More… ↓

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