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
Wake Forest University Health Sciences	Phase 2
National Cancer Institute (NCI)	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			Y
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes			Y
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes			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
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010

International Patents for ATELVIA

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

Country	Patent Number	Title	Estimated Expiration
Poland	2283825
Greece	3034373
Slovenia	1753395

Supplementary Protection Certificates for ATELVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0186405	2000C/028	Belgium		PRODUCT NAME: NATRIUMRISEDRONAAT; NAT. REGISTRATION NO/DATE: 354 IS 498 F3 20000508; FIRST REGISTRATION: SE 15290 19991007
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

Market Dynamics and Financial Trajectory for Atelvia

Last updated: July 27, 2025

Introduction

Atelvia (risedronate sodium extended-release), developed by Warner Chilcott (now part of AbbVie), is an oral bisphosphonate indicated primarily for the treatment of osteoporosis in postmenopausal women. Since its launch, Atelvia's market performance has been shaped by evolving market dynamics, competitive landscape, regulatory influences, and broader healthcare industry trends. This report analyzes the current market environment, future growth drivers, and financial outlook for Atelvia, providing insights critical for stakeholders navigating this segment of osteoporosis therapeutics.

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Market Overview and Industry Landscape

Osteoporosis remains a significant public health concern, particularly among postmenopausal women, affecting an estimated 200 million women globally (1). The global osteoporosis drugs market was valued at approximately USD 12 billion in 2022, with a compound annual growth rate (CAGR) forecasted to be around 4.5% from 2023 to 2030 (2). Bisphosphonates, including Alendronate, Risedronate, Ibandronate, and Zoledronic acid, represent the mainstay treatments, accounting for a dominant market share owing to their proven efficacy and long-standing safety profiles.

Atelvia, characterized by its once-weekly extended-release formulation, differentiates itself through enhanced gastrointestinal tolerability compared to traditional immediate-release bisphosphonates, notably reducing esophageal irritation — a common adverse effect limiting compliance (3). Despite this advantage, its market share remains relatively modest within the bisphosphonate subset, primarily due to entrenched competition and clinician prescribing habits.

Key Market Drivers and Restraints

Drivers

• Growing Osteoporosis Prevalence: Aging populations worldwide reinforce the demand for osteoporosis therapies, with postmenopausal women constituting the primary demographic (4).

• Improved Patient Compliance: Atelvia’s once-weekly dosing and improved gastrointestinal tolerability foster better adherence, which correlates with improved clinical outcomes and reduced fracture risk (5).

• Innovations in Formulation: Extended-release formulations are increasingly favored for their safety and tolerability benefits, with Atelvia positioned as a respective option (6).

• Insurance Coverage and Reimbursement Policies: Favorable reimbursement schemes for osteoporosis medications, especially in developed markets, support continued prescription and sales growth.

Restraints

• Intense Competition: The dominance of established bisphosphonates like Fosamax (alendronate) and generic formulations exerts price and market share pressures (7).

• Generic Entry and Price Erosion: As patents expire or are challenged, generic versions of bisphosphonates lead to significant price declines, diminishing profitability.

• Limited Differentiation: While Atelvia’s safety profile offers some advantage, its clinical efficacy is comparable to other bisphosphonates, limiting differentiation (8).

• Concerns Over Rare Adverse Effects: Risks such as osteonecrosis of the jaw (ONJ) and atypical femoral fractures, though rare, influence prescribing practices and patient adherence.

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Regulatory and Market Access Factors

The regulatory landscape impacts Atelvia's commercial prospects. The drug gained FDA approval in 2007 for osteoporosis treatment (9), and its positioning benefits from favorable label language emphasizing gastrointestinal tolerability. However, evolving guidelines emphasizing cost-effectiveness and safety profiles influence prescribing; the widespread adoption of newer agents like denosumab and anabolic therapies (e.g., teriparatide), as well as the emergence of biosimilars, challenge traditional bisphosphonate markets.

Market access challenges, including reimbursement restrictions and prescribing limits, particularly in European countries, further influence sales trajectories. Reimbursement policies increasingly favor drugs offering superior safety and adherence profiles, which could either favor Atelvia if it demonstrates clear benefits or hamper its growth if clinicians opt for alternatives.

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Financial Trajectory and Forecast

Historical Performance

While specific sales figures for Atelvia are not publicly detailed due to AbbVie's aggregation of osteoporosis drugs within broader portfolios, industry estimates suggest modest revenues, constrained by competitive pressures. The drug’s launch provided a niche segment advantage, but subsequent price competition and the proliferation of generic bisphosphonates dampened margins.

Forecasting Future Trends

• Short-Term Outlook (2023–2025):
  Market penetration is expected to remain flat or decline marginally, influenced by generic erosion and competition from newer agents like denosumab. Nevertheless, Atelvia may sustain a niche segment, especially in markets where clinicians prioritize gastrointestinal safety over cost.

• Mid to Long-Term Outlook (2026–2030):
  Potential growth hinges on strategic moves such as formulations with improved dosing schedules, combination therapy protocols, or targeted marketing campaigns emphasizing safety advantages. Innovations to enhance adherence, patient education, and expanded indications may bolster revenues.

However, the increasing dominance of biologics and anabolic therapies (e.g., abaloparatide) could further encroach upon the bisphosphonate market. Additionally, patent expirations will likely intensify price competition, compress profit margins, and reduce overall sales potential for Atelvia.

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Market Challenges and Opportunities

Challenges

• Price erosion due to generics
• Competition from newer therapeutic classes
• Safety perceptions influencing prescribing habits
• Regulatory shifts favoring innovative, high-efficacy agents

Opportunities

• Targeted marketing emphasizing tolerability and adherence
• Development of combination therapies to broaden indications
• Expansion into emerging markets with rising osteoporosis prevalence
• Formulation innovations offering further safety improvements

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Conclusion

The financial trajectory of Atelvia is characterized by a challenging landscape dominated by intense competition, pricing pressures, and evolving clinical paradigms. While the drug offers specific advantages in tolerability, its long-term growth prospects depend on strategic differentiation, market expansion, and adaptation to therapeutic innovations. Stakeholders must closely monitor market trends, regulatory developments, and emerging treatment options to optimize the positioning and value of Atelvia within osteoporosis management.

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Key Takeaways

• Atelvia occupies a niche in the osteoporosis treatment market, primarily appealing to patients with gastrointestinal sensitivities.
• Market growth is constrained by generic competition and the adoption of newer therapeutic agents offering superior efficacy or safety profiles.
• Price erosion and reimbursement challenges threaten long-term revenue stability.
• Innovation in drug formulations, targeted marketing, and geographic expansion are critical for sustaining and enhancing Atelvia’s financial footprint.
• The broader osteoporosis drug market is evolving rapidly, emphasizing the need for continuous strategic assessment by stakeholders.

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FAQs

1. What are the unique advantages of Atelvia compared to other bisphosphonates?
   Atelvia’s extended-release formulation improves gastrointestinal tolerability, potentially increasing patient adherence and reducing esophageal irritation compared to traditional bisphosphonates.

2. How does market competition impact Atelvia’s sales?
   Dominance of generic bisphosphonates and the rise of alternative treatments like denosumab diminish Atelvia's market share and exert downward pressure on pricing.

3. Are there opportunities for Atelvia in emerging markets?
   Yes. Rising osteoporosis prevalence and increasing healthcare infrastructure investments in emerging markets present growth opportunities, provided regulatory and reimbursement frameworks align favorably.

4. What are the primary risks facing Atelvia’s future profitability?
   Patent expirations, generic competition, safety concerns, and shifts toward newer therapeutic classes pose significant risks to revenue stability.

5. Will innovations in osteoporosis treatments threaten Atelvia’s market position?
   Yes. The advent of biologics and anabolic agents, with their higher efficacy profiles, could further erode Atelvia’s market share unless it adapts through formulation improvements or expanded indications.

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Sources

1. [1] International Osteoporosis Foundation. "Osteoporosis Facts and Statistics." 2022.
2. [2] MarketsandMarkets. "Osteoporosis Drugs Market by Drug Class, Route of Administration, and Region - Global Forecast to 2030." 2022.
3. [3] FDA. "Labeling for Atelvia." 2007.
4. [4] NIH. "Osteoporosis Overview." 2022.
5. [5] García-Gavilán, J. F., et al. "Patient adherence to osteoporosis medication: a literature review." Rheumatology International, 2019.
6. [6] McClung, M. R. "Bisphosphonates in Osteoporosis: Advances and Challenges." Current Rheumatology Reports, 2021.
7. [7] IQVIA. "Pharmaceutical Market Trends and Competitive Dynamics," 2022.
8. [8] Kanis, J. A., et al. "The Burden of Osteoporosis." Calcified Tissue International, 2021.
9. FDA. "Approved Drug Products: Atelvia." 2007.