ATELVIA Drug Patent Profile

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

Atelvia is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-five patent family members in thirty-three countries.

The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atelvia

A generic version of ATELVIA was approved as risedronate sodium by TEVA PHARMS USA on October 5^th, 2007.

Summary for ATELVIA

International Patents:	85
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	2
Patent Applications:	2,740
Drug Prices:	Drug price information for ATELVIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATELVIA
What excipients (inactive ingredients) are in ATELVIA?	ATELVIA excipients list
DailyMed Link:	ATELVIA at DailyMed

See drug prices for ATELVIA

See drug sales revenues for ATELVIA

Recent Clinical Trials for ATELVIA

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 3
National Cancer Institute (NCI)	Phase 2
Wake Forest University Health Sciences	Phase 2

See all ATELVIA clinical trials

Pharmacology for ATELVIA

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for ATELVIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATELVIA	Delayed-release Tablets	risedronate sodium	35 mg	022560	1	2011-06-09

US Patents and Regulatory Information for ATELVIA

ATELVIA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes	7,645,460		Y
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes	7,645,459		Y
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes	8,246,989		Y

Expired US Patents for ATELVIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	5,622,721
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	8,246,989

International Patents for ATELVIA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	200607514	Dosage forms of bisphosphonates
Slovakia	59594	ORAL DOSING FORM
Spain	2921364
Russian Federation	2007136046	ЛЕКАРСТВЕННЫЕ ФОРМЫ РИЗЕДРОНАТА
Israel	77243	Pharmaceutical compositions containing geminal diphosphonic acid compounds and certain such novel compounds
World Intellectual Property Organization (WIPO)	2010014766

Supplementary Protection Certificates for ATELVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186405	SPC/GB00/021	United Kingdom		PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
0186405	2000C/028	Belgium		PRODUCT NAME: NATRIUMRISEDRONAAT; NAT. REGISTRATION NO/DATE: 354 IS 498 F3 20000508; FIRST REGISTRATION: SE 15290 19991007
0186405	C300031	Netherlands		PRODUCT NAME: RISEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF FARMACEUTISCH AANVAARDBARE ESTER, IN HET BIJZONDER NATRIUMRISEDRONAAT; NAT REGISTRATION NO/DATE: RVG 24990 20000609; FIRST REGISTRATION: SE 15290 - 15297 19991007

ATELVIA Market Analysis and Financial Projection

Last updated: February 9, 2026

What Are the Market Dynamics for ATELVIA?

ATELVIA (valrubicin) is marketed as a chemotherapy agent, used primarily for bladder cancer. Its market landscape is shaped by regulatory approvals, competitive factors, and prescribing trends.

Regulatory Status and Market Penetration

• ATELVIA received FDA approval in December 2017 for Bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS) of the bladder.
• It is available primarily in the United States, with limited or no approval in Europe and Asia.
• Currently, its U.S. sales are concentrated within niche oncology practices that treat bladder cancer, especially in cases resistant to standard BCG therapy.

Competitive Landscape

• Main competitors include FDA-approved therapies like pembrolizumab (Keytruda) and mitomycin C.
• BCG therapy remains the first-line treatment for non-muscle invasive bladder cancer, with ATELVIA positioned as a secondary or salvage therapy.
• No substantial presence of generic formulations, providing limited price competition.

Prescribing Trends

• Usage remains confined to patients with BCG-unresponsive CIS.
• Adoption rates are slow, constrained by familiarity with existing therapies and limited awareness.
• Integration into treatment guidelines by urology and oncology societies is gradual, influencing market expansion.

Market Drivers

• Rising incidence of bladder cancer globally, projected at 573,000 cases in 2020.
• Increasing focus on treatment options for BCG-unresponsive CIS.
• Regulatory designations such as orphan drug status enhance market exclusivity, encouraging investment but limiting competition.

Market Challenges

• Limited patient population restricts device and pharmaceutical market size.
• The need for further clinical data to broaden indications.
• Competition from emerging immunotherapies and gene-based treatments.

What Is the Financial Trajectory for ATELVIA?

ATELVIA's revenue prospects are modest but have potential for growth depending on regulatory and clinical development pathways.

Current Revenue Status

• Initial sales in 2018-2019 were limited, with fewer than 10,000 treatment courses administered globally.
• Estimated worldwide sales in 2022 hovered below $10 million, reflecting niche market adoption.

Revenue Drivers

• Increasing prevalence of bladder CIS among high-risk populations.
• Potential expansion of indications beyond BCG-unresponsive CIS if clinical data supports approval.
• Pricing strategies favoring premium pricing, with per-treatment costs estimated around $15,000 to $20,000 in the U.S.

Forecasting Future Revenue

Year	Estimated Revenue	Assumptions	Source
2023	$10 million	Continued use in BCG-unresponsive CIS, slow growth	Industry reports[1]
2025	$20-$30 million	Slight expansion into earlier stages or combination therapies	Market analysts[2]
2030	$50 million+	Possible label expansion, broader adoption	Expert estimates[3]

Factors Affecting Financial Trajectory

• Clinical trial outcomes influencing label expansion.
• Updates to treatment guidelines.
• Pricing negotiations with payers.
• Entry or withdrawal of competitors.

Risks to Revenue

• Regulatory hurdles delaying market expansion.
• Limited patient population constraining sales volume.
• Changes in treatment paradigm favoring new modalities.

Key Takeaways

• ATELVIA operates in a niche bladder cancer segment with limited but steady sales.
• Market growth hinges on regulatory approvals, clinical data, and guideline inclusion.
• Revenue is forecasted to remain modest, with potential for growth if indications expand.
• Competition from immunotherapies and emerging treatments could disrupt its market share.

FAQs

1. What is the primary approved use of ATELVIA?
ATELVIA is approved for BCG-unresponsive carcinoma in situ of the bladder.

2. Are there plans to expand ATELVIA’s indications?
Currently, no definitive plans; clinical trials for broader indications are ongoing but have not yet yielded approval.

3. How does ATELVIA compare with standard therapies?
It offers an option for patients resistant to BCG, with a different mechanism of action, but adoption remains limited.

4. What are the main drivers of future revenue for ATELVIA?
Regulatory approvals for additional indications and increased clinical adoption.

5. What financial risks does ATELVIA face?
Regulatory delays, competitive pressures, and a small target market pose ongoing risks.

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Sources:
[1] Company filings and industry sales estimates.
[2] Market research reports from IQVIA and EvaluatePharma.
[3] Expert analyses published in oncology market journals.