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Last Updated: January 6, 2025

GLYCORT Drug Patent Profile


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When do Glycort patents expire, and when can generic versions of Glycort launch?

Glycort is a drug marketed by Heran and is included in one NDA.

The generic ingredient in GLYCORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Glycort

A generic version of GLYCORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Summary for GLYCORT
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 109
Patent Applications: 4,497
DailyMed Link:GLYCORT at DailyMed
Drug patent expirations by year for GLYCORT

US Patents and Regulatory Information for GLYCORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heran GLYCORT hydrocortisone LOTION;TOPICAL 087489-001 Oct 3, 1983 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

EU/EMA Drug Approvals for GLYCORT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185
Treatment of adrenal insufficiency in adults.
Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

GLYCORT Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Type 2 Diabetes and Related Therapeutics

Introduction to the Market

The market for type 2 diabetes therapeutics is a complex and rapidly evolving sector, driven by increasing incidence and prevalence of the disease globally. In 2012, the global revenue from type 2 diabetes drug sales was approximately $36.89 billion, highlighting the significant economic impact of this market[1].

Key Players and Market Segments

Non-Insulin Therapeutics

The non-insulin therapeutics segment is dominated by several key classes of drugs, including GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT2 inhibitors. Drugs like Novo Nordisk’s Victoza (liraglutide) and Merck’s Januvia have been instrumental in driving growth in this segment. Metformin remains the most widely prescribed diabetes therapeutic worldwide[1].

GLP-1 Receptor Agonists

GLP-1 receptor agonists, such as liraglutide and semaglutide, have seen strong uptake due to their efficacy in weight loss and glycemic control. Companies like Eli Lilly and Novo Nordisk are leaders in this space, with Eli Lilly’s pipeline including next-generation GLP-1s like a triple hormone receptor agonist and a daily oral GLP-1[3].

Market Growth and Opportunities

Estimated Market Size

The U.S. market alone is estimated to offer a $100 billion to $150 billion per year opportunity for GLP-1 therapeutics, assuming 60% penetration among diabetics and 30% among other eligible obese patients by 2030. This growth is driven by high demand for obesity treatments, which are expected to scale more rapidly than other medications[3].

Global Expansion

The global market for type 2 diabetes therapeutics is expanding rapidly, with significant growth potential in regions like Europe and the Asia Pacific. Europe’s well-established pharmaceutical industry and robust healthcare infrastructure make it a lucrative region, while the Asia Pacific region is poised for rapid growth due to increasing healthcare investments[4].

Financial Trajectory of Key Companies

Eli Lilly

Eli Lilly, a major player in the GLP-1 space, is expected to see significant growth. The company’s sales are projected to triple, and earnings to quadruple by 2030. Eli Lilly’s strong R&D productivity, first-mover advantage, and payer relationship advantages position it for long-term growth[3].

Novo Nordisk

Novo Nordisk, another leader in diabetes therapeutics, continues to see strong sales from its GLP-1 products. The company’s financial performance is bolstered by the continued success of Victoza and other products in its portfolio.

Impact of New Therapeutics on Related Markets

Obesity Treatments

The emergence of GLP-1 therapeutics is reshaping the obesity treatment landscape. These drugs have the potential to reduce the demand for bariatric surgeries, impacting companies like Intuitive Surgical, Inc. However, they also offer a significant growth opportunity for health care, with the potential to become one of the largest growth areas in the history of health care[3].

Challenges and Risks

Safety Concerns and Regulatory Issues

Historically, drugs like glitazones (TZDs) faced significant declines in sales due to serious safety issues. This highlights the importance of safety and regulatory compliance in the pharmaceutical industry. Companies must navigate these challenges to maintain market share and growth[1].

Competition and Market Dynamics

The market is highly competitive, with a duopoly in the GLP-1 space dominated by Eli Lilly and Novo Nordisk until at least 2027 or 2028. New entrants and innovative products can disrupt this landscape, but established players have strong competitive advantages[3].

Financial Performance Metrics

Revenue Growth

Companies in this sector often report significant revenue growth. For example, Glycorex, a medical technology company, reported a 19.4% increase in net sales in the third quarter of 2024 compared to the same period last year[2].

Profitability and Cash Flow

Despite revenue growth, many companies face challenges in maintaining profitability. Glycorex, for instance, reported an operating loss of SEK -3.0 million in the third quarter of 2024, although this was an improvement from the previous year. Cash flow and liquidity remain critical for these companies to fund ongoing operations and expansion[2].

Future Outlook

Technological Advancements

Technological advancements in drug delivery systems and global growth in pharmaceutical research and development are driving market growth. The Asia Pacific region, in particular, is expected to exhibit rapid growth due to increasing healthcare investments and a rapidly evolving market landscape[4].

Market Penetration

The potential for GLP-1 therapeutics to penetrate a large portion of the diabetic and obese population is significant. With list prices ranging from $12,000 to $16,000 per year, and negotiated discounts bringing the cost down to around $6,000 per year, these drugs are expected to become more accessible over time[3].

Key Takeaways

  • The global market for type 2 diabetes therapeutics is highly lucrative, with significant growth potential.
  • GLP-1 receptor agonists are a key segment driving market growth.
  • Companies like Eli Lilly and Novo Nordisk are leaders in this space, with strong financial trajectories.
  • New therapeutics are reshaping the obesity treatment landscape.
  • Safety concerns and regulatory issues are critical challenges.
  • Technological advancements and global healthcare investments are driving market expansion.

FAQs

Q: What is the estimated market size for GLP-1 therapeutics in the U.S.?

A: The estimated market size for GLP-1 therapeutics in the U.S. is between $100 billion to $150 billion per year by 2030[3].

Q: Which companies are leaders in the GLP-1 space?

A: Eli Lilly and Novo Nordisk are the undisputed leaders in the GLP-1 space[3].

Q: How are new GLP-1 therapeutics impacting the obesity treatment market?

A: New GLP-1 therapeutics are reducing the demand for bariatric surgeries and reshaping the obesity treatment landscape[3].

Q: What are the key drivers of market growth in the Asia Pacific region?

A: Increasing healthcare investments and a rapidly evolving market landscape are key drivers of market growth in the Asia Pacific region[4].

Q: What are the potential long-term financial prospects for Eli Lilly?

A: Eli Lilly’s sales are projected to triple, and earnings to quadruple by 2030, with continued growth expected beyond that period[3].

Sources

  1. The Market for Type 2 Diabetes Therapeutics - Key Findings From a Recent Analysis of Global Drug Development Efforts - Drug Development.
  2. Glycorex reduces motion loss - MarketScreener.
  3. A Multi-Billion-Dollar Drug Market - Baron Capital Group.
  4. Pharmaceutical Grade Polyethylene Glycol (PEG) Market Size And Forecast - Verified Market Research.
  5. GlycoMimetics: Drug Approval Is Not Coming In 2024, But The Hype Could Be Real - Seeking Alpha.

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