HEMADY Drug Patent Profile

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

Hemady is a drug marketed by Dexcel and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in HEMADY is dexamethasone. There are thirty-nine drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hemady

A generic version of HEMADY was approved as dexamethasone by HIKMA on September 15^th, 1983.

Summary for HEMADY

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	43
Patent Applications:	4,795
Drug Prices:	Drug price information for HEMADY
What excipients (inactive ingredients) are in HEMADY?	HEMADY excipients list
DailyMed Link:	HEMADY at DailyMed

See drug prices for HEMADY

Recent Clinical Trials for HEMADY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mayo Clinic	Phase 1
City of Hope Medical Center	Phase 1
Southwest Oncology Group	Phase 3

See all HEMADY clinical trials

Pharmacology for HEMADY

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for HEMADY

HEMADY is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes			Y
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes			Y
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for HEMADY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Ozurdex	dexamethasone	EMEA/H/C/001140 Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.	Authorised	no	no	no	2010-07-26
THERAVIA	Neofordex	dexamethasone	EMEA/H/C/004071 Treatment of multiple myeloma.	Authorised	no	no	no	2016-03-16

International Patents for HEMADY

See the table below for patents covering HEMADY around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019123453

Supplementary Protection Certificates for HEMADY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003

Market Dynamics and Financial Trajectory for Hematology Drugs: A Comprehensive Overview

Introduction to Hematology Drugs

Hematology drugs are a crucial segment of the pharmaceutical industry, focusing on the treatment of blood disorders such as anemia, hemophilia, and various types of blood cancers. The market for these drugs is experiencing significant growth, driven by several key factors.

Global Market Size and Growth

The global hematology drugs market has been on an upward trajectory. In 2021, the market size was valued at $33.06 billion, and it is expected to grow to $36.13 billion in 2022, representing a compound annual growth rate (CAGR) of 9.3%[1].

By 2026, the market is projected to reach $73.67 billion at a CAGR of 19.5%, driven by stable economic growth in both developed and developing countries, as well as recovering commodity prices[1].

Key Drivers of Market Growth

Economic Growth and Healthcare Spending

Stable economic growth in many regions is a significant driver. The International Monetary Fund (IMF) reported global GDP growth rates of 3.3% in 2020 and 3.4% in 2021, which is expected to increase spending on healthcare services, thereby driving the demand for hematology drugs[1].

Advancements in Medical Technology

Advancements in novel therapies, gene editing technologies, and personalized medicine are also driving the market. For example, the hemophilia A market, a subset of hematology drugs, is expected to grow significantly due to these advancements, reaching $28,447.2 million by 2034 from $10,288.7 million in 2023[3].

Increasing Prevalence of Blood Disorders

The rising cases of anemia globally and the increasing geriatric population are additional factors contributing to the growth of the hematology drugs market. These demographic changes lead to higher healthcare expenditure and increased demand for effective treatments[4].

Market Segmentation

Mode of Purchase

The hematology drugs market is segmented by mode of purchase into prescription drugs and over-the-counter (OTC) drugs. Prescription drugs were the largest segment, accounting for 94.8% of the total market in 2020. However, the OTC segment is expected to be the fastest-growing segment, with a CAGR of 12.2% during 2020-2025[4].

Geographic Regions

Asia Pacific was the largest region in the hematology drugs market, accounting for 35.6% of the total in 2020. South America and Africa are expected to be the fastest-growing regions, with CAGRs of 12.0% and 11.5%, respectively, during 2020-2025[4].

Financial Projections and Spending Trends

Total Drug Spending

Total drug spending is projected to grow significantly. According to CMS projections, total drug spending will increase from $500 billion in 2018 to $863 billion in 2028, representing 13.7% to 13.9% of national health expenditures (NHE)[2].

Medicare and Medicaid Spending

Medicare’s share of overall prescription spending is expected to continue growing, reaching 36% by 2032. However, the spending growth rate will fluctuate, with significant growth in 2026 and 2027 due to changes in rebate structures under the Inflation Reduction Act[5].

Medicaid’s share of prescription drug spending, which peaked during the COVID-19 pandemic, is expected to decline as enrollment decreases. CMS projects that Medicaid enrollment will have peaked in 2023, leading to a decline in Medicaid’s share of prescription drug spending[5].

Regulatory and Policy Impacts

Pricing Pressures and Regulatory Changes

The market is restrained by pricing pressures from regulators and challenges due to regulatory changes. Efforts to increase transparency and reduce spending on prescription drugs, such as promoting competition among drug manufacturers and reducing pay-for-delay deals, are ongoing[2].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the market, leading to operational challenges and changes in healthcare spending patterns. While the pandemic accelerated some aspects of healthcare spending, it also led to a decline in nonretail drug spending in clinic settings[2].

Future Outlook and Growth Opportunities

Emerging Markets

Emerging markets, particularly in South America and Africa, are expected to grow faster than developed markets. This growth will be driven by increasing healthcare awareness and expenditure, as well as rising cases of anemia and other blood disorders[4].

Innovations in Treatment

Advancements in gene therapy and personalized medicine will continue to drive the market. For instance, the development of novel therapies for hemophilia A is expected to significantly expand the market size and offer more effective treatment options[3].

Challenges and Restraints

High Drug Costs

One of the major challenges facing the hematology drugs market is the high cost of drugs. This can limit access to these medications, especially in regions with low per capita healthcare expenditure[4].

Regulatory Hurdles

Regulatory changes and pricing pressures from regulators can also hinder market growth. Companies must navigate these challenges to maintain profitability and ensure the availability of these critical medications[4].

Key Takeaways

• The global hematology drugs market is expected to grow significantly, driven by economic growth, advancements in medical technology, and increasing prevalence of blood disorders.
• The market is segmented by mode of purchase and geographic regions, with prescription drugs and Asia Pacific being the dominant segments.
• Total drug spending is projected to increase, with Medicare and Medicaid playing significant roles in the financial trajectory.
• Regulatory and policy changes, as well as the impact of COVID-19, will continue to shape the market.
• Emerging markets and innovations in treatment offer substantial growth opportunities.

FAQs

What is the projected growth rate of the global hematology drugs market?

The global hematology drugs market is expected to grow at a CAGR of 19.5% from 2022 to 2026, reaching $73.67 billion by 2026[1].

How does the COVID-19 pandemic impact the hematology drugs market?

The COVID-19 pandemic led to operational challenges and changes in healthcare spending patterns. It accelerated some aspects of healthcare spending but also led to a decline in nonretail drug spending in clinic settings[2].

What are the key drivers of the hematology drugs market?

Key drivers include stable economic growth, advancements in medical technology, increasing prevalence of blood disorders, and rising healthcare expenditure[1][3][4].

Which regions are expected to be the fastest-growing in the hematology drugs market?

South America and Africa are expected to be the fastest-growing regions, with CAGRs of 12.0% and 11.5%, respectively, during 2020-2025[4].

How will regulatory changes impact the hematology drugs market?

Regulatory changes aimed at increasing transparency and reducing spending on prescription drugs, such as promoting competition among manufacturers and reducing pay-for-delay deals, will continue to shape the market[2].

Sources

1. The Business Research Company, "Hematology Drugs Market Size 2022 And Growth Analysis".
2. JAMA Health Forum, "Projections of US Prescription Drug Spending and Key Policy Considerations".
3. BioSpace, "Hemophilia A Market Size to Reach USD 28,447.2 Million by 2034".
4. GlobeNewswire, "$78.8 Billion Worldwide Hematology Drugs Industry to 2030 - Identify Growth Segments for Investment".
5. Drug Channels, "Who Will Pay for Prescription Drugs in 2032: Four Takeaways from CMS Projections".