RALOXIFENE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for raloxifene hydrochloride and what is the scope of freedom to operate?

Raloxifene hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms Inc, Teva Pharms Usa, and Watson Labs Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for raloxifene hydrochloride. Eighteen suppliers are listed for this compound.

Summary for RALOXIFENE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	86
Patent Applications:	6,154
What excipients (inactive ingredients) are in RALOXIFENE HYDROCHLORIDE?	RALOXIFENE HYDROCHLORIDE excipients list
DailyMed Link:	RALOXIFENE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for RALOXIFENE HYDROCHLORIDE

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

Sponsor	Phase
Cairo University	Phase 2
German University in Cairo	Phase 2
Guangzhou University of Traditional Chinese Medicine	N/A

See all RALOXIFENE HYDROCHLORIDE clinical trials

Pharmacology for RALOXIFENE HYDROCHLORIDE

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for RALOXIFENE HYDROCHLORIDE

Bone Density Conservation Agents

Estrogen Antagonists

Selective Estrogen Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for RALOXIFENE HYDROCHLORIDE

G03XC	Selective estrogen receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for RALOXIFENE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cadila Pharms Ltd	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	211324-001	Aug 18, 2020	AB	RX	No	No
Glenmark Pharms Ltd	RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	204491-001	Mar 22, 2016	AB	RX	No	No
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	AB	RX	Yes	Yes

Expired US Patents for RALOXIFENE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	RE38968
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	5,659,087
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	5,843,984

RALOXIFENE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Raloxifene Hydrochloride

Global Market Overview

The global market for Raloxifene Hydrochloride is poised for significant growth, driven by several key factors. As of 2023, the market was estimated at US$1.3 billion and is projected to reach US$2.0 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.8% during the analysis period of 2023-2030[1][3].

Regional Market Dynamics

The market dynamics vary significantly across different regions. The U.S. market, for instance, is estimated at US$362.6 million in 2023, while China, the second-largest economy, is forecast to grow at a CAGR of 9.5% and reach a projected market size of US$421.7 million by 2030. Other notable markets include Japan and Canada, which are forecast to grow at CAGRs of 2.4% and 5.9%, respectively[1].

End-Use Segments

The Pharmaceuticals End-Use segment is one of the most significant, expected to record a 6.2% CAGR and reach US$1.5 billion by the end of the analysis period. The Chemicals End-Use segment is also growing, albeit at a slightly lower CAGR of 5.0%[1].

Demographic and Healthcare Trends

The expanding demographic of postmenopausal women, particularly in regions like North America, Europe, and parts of Asia-Pacific, is a primary driver of the market. This segment is prone to osteoporosis and breast cancer, creating a substantial demand for effective therapies like Raloxifene Hydrochloride. Increasing healthcare investments in emerging markets such as India, China, and Brazil are also driving the demand for advanced therapeutic options[1][4].

Technological Innovations and Drug Formulations

Technological innovations in drug formulation, such as sustained-release tablets and new delivery systems, have enhanced the drug’s profile, making it more accessible and easier to administer. These innovations improve patient adherence and extend the drug’s market reach by making it suitable for a broader range of patients[1].

Market Drivers

Several factors are driving the growth of the Raloxifene Hydrochloride market:

• Advancements in Drug Formulation: Innovations in drug delivery systems are improving patient compliance and convenience.
• Increasing Focus on Women’s Health: Rising awareness of osteoporosis and breast cancer is propelling the demand for effective therapies.
• Rising Healthcare Expenditure: Improving economic conditions in emerging markets are leading to greater access to healthcare.
• Strategic Partnerships: Collaborations between pharmaceutical companies and healthcare providers are expanding distribution channels and increasing market penetration[1][4].

Challenges and Barriers

Despite the growth potential, the market faces several challenges:

• Limited Healthcare Access: In developing countries, limited healthcare access and affordability remain significant barriers.
• Venous Thromboembolism Risk: Raloxifene Hydrochloride is associated with an increased risk of venous thromboembolism, which can be a deterrent for some patients[2][5].

Geographic Growth

Developed regions with high healthcare standards, such as the United States, Canada, and several European countries, remain the primary consumers of Raloxifene Hydrochloride. However, developing countries in Asia-Pacific and Latin America are poised to become significant contributors to the market. The higher prevalence of osteoporosis among Asian women due to genetic factors is also boosting demand[1].

Government Initiatives and Public Awareness

Governments in emerging markets are implementing healthcare reforms to expand coverage for essential medications, including those for osteoporosis and cancer prevention. Public awareness campaigns and partnerships between government agencies and pharmaceutical companies are helping to educate people about the benefits of early treatment, which is likely to bolster demand for Raloxifene Hydrochloride[1].

Market Segmentation

The Raloxifene market is segmented by drug class, application, demographic, dosage form, route of administration, and end-user. Key segments include:

• Application: Osteoporosis, breast cancer prevention, and others.
• Dosage Form: Tablets and capsules.
• Route of Administration: Oral and others.
• End-User: Clinics, hospitals, and others.
• Distribution Channel: Hospital pharmacy, retail pharmacy, and online pharmacy[4].

Financial Projections

The global Raloxifene market size was valued at USD 606.9 million in 2023 and is projected to reach USD 1,048.24 million by 2031, growing at a CAGR of 5.9% during the forecast period of 2024 to 2031[4].

Key Players and Market Strategies

Key players in the market are focusing on improving drug formulations and enhancing distribution channels to reach a broader patient base. Strategic partnerships, aggressive marketing, and educational campaigns are critical in raising awareness about Raloxifene’s benefits and influencing prescribing patterns and patient choices[1][4].

Illustrative Statistics

• Market Size: Expected to reach US$2.0 billion by 2030 from US$1.3 billion in 2023[1][3].
• CAGR: 5.8% over the analysis period 2023-2030[1].
• Regional Growth: China forecast to grow at a CAGR of 9.5%[1].
• Venous Thromboembolism Risk: Occurs in about 1 out of 100 patients treated with Raloxifene Hydrochloride[2].

"Raloxifene therapy has also been shown to reduce the risk of invasive breast cancer by 76% in women with osteoporosis at a median of 40 months of observation."[5]

Key Takeaways

• The global Raloxifene Hydrochloride market is expected to grow significantly, driven by advancements in drug formulation and increasing focus on women’s health.
• Regional dynamics, particularly in Asia-Pacific and Latin America, are crucial due to improving healthcare infrastructure and government initiatives.
• Despite challenges such as limited healthcare access and venous thromboembolism risk, the market is poised for growth driven by strategic partnerships and public awareness campaigns.
• Key players are focusing on improving drug formulations and distribution channels to expand market reach.

Frequently Asked Questions (FAQs)

1. What is the projected market size of Raloxifene Hydrochloride by 2030?

The global market for Raloxifene Hydrochloride is expected to reach US$2.0 billion by 2030[1][3].

2. What are the primary drivers of the Raloxifene Hydrochloride market?

The primary drivers include advancements in drug formulation, increasing focus on women’s health, and rising healthcare investments in emerging markets[1][4].

3. Which regions are expected to see significant growth in the Raloxifene Hydrochloride market?

Developed regions like the U.S. and Europe, as well as emerging markets in Asia-Pacific and Latin America, are expected to see significant growth[1].

4. What are the major challenges facing the Raloxifene Hydrochloride market?

Major challenges include limited healthcare access in developing countries and the risk of venous thromboembolism associated with the drug[2][5].

5. How is the market segmented, and what are the key segments?

The market is segmented by drug class, application, demographic, dosage form, route of administration, and end-user. Key segments include osteoporosis and breast cancer prevention, tablets and capsules, and hospital pharmacy and retail pharmacy distribution channels[4].

Sources Cited:

1. Global Raloxifene Hydrochloride Market to Reach US$2.0 Billion by 2030 - MarketResearch.com
2. ANDA 78193 | FDA - FDA
3. Raloxifene Hydrochloride - GII Research - GII Research
4. Raloxifene Market Size, Trends, Share, Growth - Forecast By 2031 - Data Bridge Market Research
5. Long-term Effects of Raloxifene on Bone Mineral Density, Bone ... - JAMA Network