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Last Updated: December 25, 2024

ARISTOGEL Drug Patent Profile


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

Aristogel is a drug marketed by Astellas and is included in one NDA.

The generic ingredient in ARISTOGEL is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aristogel

A generic version of ARISTOGEL was approved as triamcinolone acetonide by TARO on October 1st, 1986.

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Summary for ARISTOGEL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 82
Patent Applications: 4,320
DailyMed Link:ARISTOGEL at DailyMed
Drug patent expirations by year for ARISTOGEL

US Patents and Regulatory Information for ARISTOGEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas ARISTOGEL triamcinolone acetonide GEL;TOPICAL 083380-001 Approved Prior to Jan 1, 1982 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

ARISTOGEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the U.S. Pharmaceutical Market: Implications for Drugs Like ARISTOGEL

Introduction to the U.S. Pharmaceutical Market

The U.S. pharmaceutical market is one of the largest and most dynamic in the world. As of 2023, the market size was valued at USD 602.19 billion, and it is projected to reach USD 1,093.79 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 6.15% from 2024 to 2033[1].

Market Segmentation and Dominant Sectors

Molecule Type

The market is segmented based on molecule type, with conventional drugs (small molecules) dominating the market with a 56.21% revenue share in 2023. However, the biologics and biosimilars segment is expected to witness the fastest growth over the forecast period, driven by their increasing acceptance and efficacy in treating complex diseases[1].

Branded vs. Generic Drugs

The branded segment held a significant revenue share of 68.19% in 2023, indicating the strong market presence of branded pharmaceuticals. However, the generic and biosimilar segments are gaining traction due to their cost-effectiveness and similar efficacy profiles[1].

Prescription vs. Over-the-Counter (OTC) Drugs

Prescription drugs dominated the market with an 88.23% revenue share in 2023. However, the OTC segment is poised for significant growth, driven by the high cost of prescription pharmaceuticals and the increasing approval of OTC drugs[1].

Disease Segmentation

Cancer and Neurological Disorders

The cancer segment dominated the market with a 16.79% share in 2023. However, neurological disorders are expected to witness the fastest CAGR from 2024 to 2033, driven by the rising prevalence of conditions such as Alzheimer's disease and Parkinson's disease[1].

Route of Administration

Oral and Parenteral Routes

The oral route of administration dominated the market with a 59.9% revenue share in 2023. However, the parenteral route is expected to expand at the fastest CAGR over the forecast period, driven by advancements in biologics and biosimilars which often require parenteral administration[1][4].

End Market Dynamics

Hospitals and Clinics

Hospitals dominated the pharmaceutical market with a 51.66% revenue share in 2023. Clinics, however, are estimated to expand at the fastest CAGR from 2024 to 2033, reflecting the shift towards outpatient care and the increasing role of clinics in drug administration[1].

Financial Trajectory of Pharmaceutical Companies

Revenue Growth and Operational Efficiency

Companies like Blueprint Medicines have shown significant revenue growth. For instance, Blueprint Medicines achieved AYVAKIT net product revenues of $114.1 million in the second quarter of 2024, representing over 185% growth year-over-year. This growth is attributed to operational efficiency and the successful commercialization of their products[2].

Research and Development (R&D) Expenses

R&D expenses are a critical component of the pharmaceutical industry. Blueprint Medicines reported R&D expenses of $84.3 million in the second quarter of 2024, down from $110.1 million in the same period in 2023, due to operational efficiency and the timing of clinical trial materials[2].

Selling, General, and Administrative (SG&A) Expenses

SG&A expenses also play a crucial role, particularly in the commercialization phase. Blueprint Medicines saw an increase in SG&A expenses to $89.3 million in the second quarter of 2024, primarily due to activities supporting the commercialization of AYVAKIT/AYVAKYT[2].

Implications for Drugs Like ARISTOGEL

Market Opportunity

Given the growing market size and the increasing demand for innovative treatments, drugs like ARISTOGEL have a significant market opportunity. If ARISTOGEL falls within the biologics or biosimilars segment, it could benefit from the fastest growth rate in this category[1].

Competitive Landscape

The pharmaceutical market is highly competitive, with both branded and generic drugs vying for market share. ARISTOGEL would need to differentiate itself through its efficacy, safety profile, and cost-effectiveness to gain a competitive edge[1].

Regulatory Approval and Access

The FDA approval process is crucial for any new drug. For instance, Pfizer Inc. and OPKO Health Inc. received FDA approval for NGENLA, a human growth hormone medication, in June 2023. Securing such approvals can significantly impact the market trajectory of a drug like ARISTOGEL[1].

Future Trends and Growth Drivers

Biologics and Biosimilars

The biologics market is expected to grow significantly, with a projected size of USD $601.26 billion by 2029, growing at a CAGR of 6.96% from 2024 to 2029. This trend is driven by technological advancements and patient-centric approaches[4].

Parenteral Drug Administration

The parenteral drug market is evolving, with a focus on biologics and biosimilars. This segment is expected to see rapid growth due to its efficacy in treating complex diseases and the convenience of administration[4].

Cost-Effectiveness and Access

The cost of pharmaceuticals is a significant factor influencing market dynamics. As access to drugs grows, the net price of these drugs is expected to come down, making them more accessible to a broader population. This trend could impact the pricing strategy for ARISTOGEL[3].

Key Takeaways

  • The U.S. pharmaceutical market is projected to reach USD 1,093.79 billion by 2033, driven by the growth of biologics, biosimilars, and parenteral drug administration.
  • The biologics and biosimilars segment is expected to witness the fastest growth rate.
  • Regulatory approvals and cost-effectiveness are critical factors for the success of new drugs.
  • The shift towards outpatient care and the increasing role of clinics will influence the end market dynamics.
  • Operational efficiency and successful commercialization are key to revenue growth for pharmaceutical companies.

Frequently Asked Questions (FAQs)

Q: What is the projected size of the U.S. pharmaceutical market by 2033? A: The U.S. pharmaceutical market is expected to reach around USD 1,093.79 billion by 2033[1].

Q: Which segment is expected to grow the fastest in the U.S. pharmaceutical market? A: The biologics and biosimilars segment is expected to witness the fastest growth rate from 2024 to 2033[1].

Q: What is driving the growth of the parenteral drug market? A: The parenteral drug market is driven by technological advancements, global market dynamics, and patient-centric approaches, particularly the rising prominence of biologics and biosimilars[4].

Q: How do regulatory approvals impact the market trajectory of new drugs? A: Regulatory approvals, such as FDA approval, are crucial for the market success of new drugs, enabling them to be prescribed and sold in the market[1].

Q: What are the key factors influencing the cost of pharmaceuticals? A: The cost of pharmaceuticals is influenced by factors such as access, regulatory approvals, and the shift towards cost-effective alternatives like OTC drugs[3].

Sources Cited

  1. U.S. Pharmaceutical Market Size to Reach USD 1,093.79 Billion By 2033 - Biospace
  2. Blueprint Medicines Reports Second Quarter 2024 Results and Raises AYVAKIT®/AYVAKYT® (avapritinib) Full Year Revenue Guidance - Blueprint Medicines
  3. A Multi-Billion-Dollar Drug Market - Baron Capital Group
  4. The Evolving Landscape of Parenteral Drug Administration - PCI Pharma Services

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