EVISTA Drug Patent Profile

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

Evista is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in EVISTA is raloxifene hydrochloride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evista

A generic version of EVISTA was approved as raloxifene hydrochloride by TEVA PHARMS USA on March 4^th, 2014.

Summary for EVISTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	23
Patent Applications:	3,781
Drug Prices:	Drug price information for EVISTA
What excipients (inactive ingredients) are in EVISTA?	EVISTA excipients list
DailyMed Link:	EVISTA at DailyMed

See drug prices for EVISTA

See drug sales revenues for EVISTA

Recent Clinical Trials for EVISTA

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

Sponsor	Phase
Massachusetts General Hospital	Phase 4
Shanghai Mental Health Center	Phase 4
Mayo Clinic	Phase 2

See all EVISTA clinical trials

Pharmacology for EVISTA

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

US Patents and Regulatory Information for EVISTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	AB	RX	Yes	Yes

Expired US Patents for EVISTA

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

International Patents for EVISTA

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	1001196
Denmark	102895
Czech Republic	9500313
Japan	2000505455
Russian Federation	2104697	USE OF BENZOTHIOPHENES FOR PROPHYLAXIS AND TREATMENT OF OSTEOPOROSIS AND PHARMACEUTICAL COMPOSITION BASED ON THEREOF

Supplementary Protection Certificates for EVISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0584952	1/1999	Austria		PRODUCT NAME: RALOXIFEN ODER DESSEN PHARMEZEUTISCH ANNEHMBARE SALZE; REGISTRATION NO/DATE: EU/1/98/073/001- EU/1/98/073/004 19980805
0584952	980044	Netherlands		PRODUCT NAME: RALOXIFENE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/98/073/001 - EU/1/98/073/004, EU/1/98/074/001 - EU/1/98/074/004 19980805 EU/1/98/073/001
0584952	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0584952	SPC/GB98/048	United Kingdom		PRODUCT NAME: RALOXIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/98/073/001 19980805; UK EU/1/98/073/002 19980805; UK EU/1/98/073/003 19980805; UK EU/1/98/073/004 19980805; UK EU/1/98/074/001 19980805; UK EU/1/98/074/002 19980805; UK EU/1/98/074/003 19980805; UK EU/1/98/074/004 19980805

EVISTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: EVISTA

Introduction to EVISTA

EVISTA, also known as raloxifene hydrochloride, is a selective estrogen receptor modulator (SERM) developed by Eli Lilly and Company. It is primarily used for the prevention and treatment of osteoporosis in postmenopausal women and has also been approved to reduce the risk of invasive breast cancer in certain populations[2][4].

Market Size and Growth

The global raloxifene market, which includes EVISTA, has been experiencing significant growth. As of 2023, the raloxifene market size was valued at USD 606.9 million and is projected to reach USD 1,048.24 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.9% during the forecast period of 2024 to 2031[4].

Segmentation and Applications

The market for EVISTA is segmented based on several factors, including drug class, application, demographic, dosage form, route of administration, and end-user.

• Applications: EVISTA is used for the treatment and prevention of osteoporosis in postmenopausal women and for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk for invasive breast cancer[2][4].
• Geographical Segmentation: North America currently leads the market due to the presence of key industry players and a robust healthcare infrastructure. However, the Asia-Pacific region is anticipated to experience significant growth driven by research and development initiatives and government investments in healthcare[4].

Competitive Landscape

EVISTA operates within a competitive women's healthcare market that includes other drugs such as Prolia, Xgeva, Mirena, Zometa, Reclast, Nuvaring, and Premarin. Despite this competition, EVISTA has maintained a strong position due to its unique benefits and approvals.

• Unique Selling Points: EVISTA's ability to mimic estrogen's beneficial effects on bone density while minimizing its risks makes it a valuable alternative to hormone replacement therapy. Its approval for reducing the risk of invasive breast cancer adds to its market appeal[2][4].

Regulatory Approvals and Clinical Trials

EVISTA has undergone extensive clinical trials and has received significant regulatory approvals.

• FDA Approvals: EVISTA was initially approved for the prevention and treatment of osteoporosis in postmenopausal women. Later, it was approved for reducing the risk of invasive breast cancer in two populations of postmenopausal women[2].
• Clinical Trials: The Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to Evista (CORE) trials demonstrated EVISTA's efficacy in reducing the risk of invasive breast cancer and improving bone density[2][5].

Safety Profile and Side Effects

While EVISTA has a favorable safety profile, it is not without risks.

• Venous Thromboembolic Events: EVISTA is associated with an increased risk of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism. It is contraindicated in women with a history of these conditions[5].
• Other Side Effects: Common side effects include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating[5].

Financial Performance and Projections

The financial performance of EVISTA is closely tied to the overall growth of the raloxifene market.

• Market Size Projections: The raloxifene market is expected to grow significantly, driven by increasing awareness of osteoporosis and the need for effective treatments. The market size is projected to increase from USD 606.9 million in 2023 to USD 1,048.24 million by 2031[4].
• Revenue Impact: The growth in market size will likely translate into increased revenue for Eli Lilly and Company, although the exact financial impact will depend on various market and competitive factors.

Innovation and Market Opportunities

The market for EVISTA is driven by several trends and innovations.

• Personalized Medicine: There is a growing focus on personalized medicine, where treatments are tailored based on individual patient profiles and genetic factors. This approach can enhance the effectiveness of EVISTA and optimize patient outcomes[4].
• Novel Drug Delivery Systems: Ongoing research into novel drug delivery systems, such as sustained-release formulations and combination therapies, aims to improve patient compliance and convenience. These innovations represent significant market opportunities for EVISTA[4].

Regional Market Dynamics

The regional dynamics play a crucial role in the market trajectory of EVISTA.

• North America: This region leads the market due to its robust healthcare infrastructure and the presence of key industry players. High disposable incomes in this region also contribute to greater access to healthcare services and medications[4].
• Asia-Pacific: This region is expected to experience significant growth due to increasing research and development initiatives and government investments in healthcare. This growth is anticipated to make the Asia-Pacific region a key player in the raloxifene market[4].

Key Takeaways

• Market Growth: The raloxifene market, including EVISTA, is projected to grow significantly, driven by increasing awareness of osteoporosis and the need for effective treatments.
• Unique Benefits: EVISTA's dual benefits in treating osteoporosis and reducing the risk of invasive breast cancer make it a valuable treatment option.
• Innovations: The market is driven by innovations in drug delivery systems and a focus on personalized medicine.
• Regional Dynamics: North America currently leads the market, but the Asia-Pacific region is expected to experience significant growth.

FAQs

Q: What is EVISTA used for? A: EVISTA is used for the prevention and treatment of osteoporosis in postmenopausal women and to reduce the risk of invasive breast cancer in certain populations.

Q: What are the unique benefits of EVISTA? A: EVISTA mimics estrogen's beneficial effects on bone density while minimizing its risks, making it a valuable alternative to hormone replacement therapy.

Q: What are the common side effects of EVISTA? A: Common side effects include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. It also carries a risk of venous thromboembolic events.

Q: How is the raloxifene market expected to grow? A: The raloxifene market is projected to grow from USD 606.9 million in 2023 to USD 1,048.24 million by 2031, with a CAGR of 5.9%.

Q: What regions are driving the growth of the raloxifene market? A: North America currently leads the market, but the Asia-Pacific region is expected to experience significant growth driven by research and development initiatives and government investments in healthcare.

Cited Sources

1. Globenewswire: Women's Health Care Market by Drugs (Prolia, Xgeva, Evista, Mirena, Zometa, Reclast, Nuvaring, Primarin, Actonel), Application (Female Infertility, Postmenopausal Osteoporosis, Endometriosis, Contraception, PCOS, Menopause) - Global Forecast to 2024.
2. Eli Lilly and Company: FDA Approves Lilly's Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women.
3. Technavio: Raloxifene Hydrochloride Market Size 2024-2028.
4. Data Bridge Market Research: Raloxifene Market Size, Trends, Share, Growth - Forecast By 2031.
5. Eli Lilly and Company: Lilly Announces Review of Data on Long-Term Raloxifene Treatment.