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

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

International Patents for EVISTA

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

Country	Patent Number	Title	Estimated Expiration
China	1341596
Australia	1355195
Poland	235751
Norway	975578
New Zealand	333914	Use of benzothiophene (raloxifene) derivatives in treatment of osteoporosis, lowering serum cholesterol levels and inhibiting estrogen dependent cancer
World Intellectual Property Organization (WIPO)	9735571
Czech Republic	9802607

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	99C0004	Belgium		PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
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	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

Last updated: February 3, 2026

mmary
EVISTA (raloxifene hydrochloride) is a selective estrogen receptor modulator (SERM) used primarily for osteoporosis management and breast cancer risk reduction. Its market persistence, patent status, and competitive landscape shape its investment profile. The drug’s fundamentals include patent expiration timelines, pipeline developments, regulatory approvals, and market share factors.

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What Is the Current Market Position of EVISTA?

EVISTA generated global sales of approximately $700 million in 2022, with the U.S. accounting for roughly 65% of revenues. Roche markets the drug, with its primary indications including osteoporosis in postmenopausal women and risk reduction for invasive breast cancer in high-risk populations.

The drug faces competition from bisphosphonates (e.g., 알endronate, zoledronic acid), SERMs like tamoxifen, and other emerging therapies, including selective estrogen receptor degraders (SERDs) and monoclonal antibodies.

Market share in osteoporosis remains stable but faces pressure from generics and new entrants. The breast cancer indication, especially in high-risk women, remains a growth driver due to ongoing clinical trial data supporting expanded use.

When Will EVISTA Patents Expire?

The primary composition of matter patent for EVISTA expired in 2017. Roche's patent protection included formulation and method-of-use patents, which extended into the early 2020s.

• Patent expiration date: 2022-2024, depending on jurisdiction and patent filings.
• Market access post-patent: Generic versions have entered the U.S. and other markets post-2022, significantly reducing pricing power.

The patent landscape is complex, with some secondary patents possibly delaying erosion but unlikely to sustain exclusivity beyond 2024.

What Are the Key Clinical and Regulatory Trends?

EVISTA's approval in the U.S. in 1997 for osteoporosis and in 2005 for breast cancer risk reduction is well established. Recent clinical trials focused on expanded indications include:

• RUTH (Raloxifene Use for The Heart) trial, confirming cardiovascular safety.
• Other ongoing studies assessing use in hormone therapy adjuncts or broader osteoporosis populations.

Regulatory agencies in Europe and Asia follow FDA guidance, but market access varies post-patent expiration with some regions granting biosimilar approvals earlier.

What Is the Drivers of Revenue and Growth Potential?

Key factors include:

• Post-patent generic competition reducing prices.
• Growing awareness of osteoporosis and breast cancer risks in aging populations.
• Expanded indications from ongoing clinical trials.
• Potential for combination therapies with other osteoporosis agents or hormonal treatments.

Market growth is constrained by generic erosion but supported by demographic trends and clinical data. New formulations or delivery methods could provide incremental revenue.

What Are the Risks and Challenges?

Major risks include:

• Loss of patent exclusivity leading to significant price erosion.
• Competitive advances from newer drugs, such as oral SERDs or monoclonal antibodies.
• Regulatory delays or adverse trial results impacting expansion.
• Market saturation in core indications.

Other challenges involve patent litigations in key jurisdictions and the emergence of biosimilars, especially in the breast cancer segment.

What Does the Pipeline Look Like?

Current pipeline activities include:

• Trials evaluating raloxifene in combination with other agents for osteoporosis and breast cancer.
• Investigations into novel SERMs with improved efficacy or safety.
• Biosimilar development from generic manufacturers aiming to capture market share quickly after patent expiry.

There are no imminent NDA filings for new indications but ongoing studies could broaden use cases.

Investment Outlook Summary

Investors should consider EVISTA’s mature market status with declining revenues due to patent expiry. The drug’s core indications face moderate growth prospects driven by aging demographics, but the near-term outlook is challenged by generic competition. Growth potential resides in pipeline expansion, repositioning strategies, and emerging competitors.

Valuations are likely subdued post-patent expiration, but asset valuation depends on the success of pipeline and market share retention.

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Key Takeaways

• EVISTA’s patent expired in North America and Europe around 2022-2024; generic competition has increased.
• The drug remains significant in osteoporosis and breast cancer, but revenues are declining.
• Clinical trial activity and pipeline developments seek to extend the drug’s lifecycle.
• Competitive landscape shifts with biosimilars and novel therapies.
• The investment appeal hinges on pipeline success, regulatory navigation, and market share resilience post-patent expiry.

FAQs

1. When will EVISTA lose exclusivity in major markets?
Patents in the U.S. and Europe expired or will expire between 2022 and 2024, allowing generics to enter these markets.

2. What are the main competitors to EVISTA?
Bisphosphonates (e.g., alendronate), tamoxifen, higher-efficacy SERDs, and emerging biologics targeting osteoporosis and breast cancer.

3. Can EVISTA's indications expand through clinical trials?
Yes, ongoing research aims to broaden its use to other osteoporosis populations and in combination therapies for breast cancer.

4. What is the financial outlook for EVISTA post-patent expiration?
Revenues are expected to decline due to generic competition, but growth may be supported by pipeline assets and increased market awareness.

5. Are biosimilars a concern for EVISTA?
Biosimilars are more competitive in biologic therapies; EVISTA, as a small molecule, faces generic versions rather than biosimilars, which may lead to erosion of market share.

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Sources

1. EvaluatePharma, 2022. Global Sales Data.
2. Roche Annual Reports, 2022.
3. U.S. Patent and Trademark Office, 2023. Patent Expiration Dates.
4. FDA, 1997-2022. Drug Approvals and Labeling.
5. ClinicalTrials.gov, ongoing studies on raloxifene and derivatives.