ACTONEL Drug Patent Profile

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

Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.

Summary for ACTONEL

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	35
Patent Applications:	2,791
Drug Prices:	Drug price information for ACTONEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTONEL
What excipients (inactive ingredients) are in ACTONEL?	ACTONEL excipients list
DailyMed Link:	ACTONEL at DailyMed

See drug prices for ACTONEL

See drug sales revenues for ACTONEL

Recent Clinical Trials for ACTONEL

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

Sponsor	Phase
Dong-A ST Co., Ltd.	Phase 4
Wake Forest University Health Sciences	Phase 3
Weill Cornell Medicine	Phase 4

See all ACTONEL clinical trials

Pharmacology for ACTONEL

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for ACTONEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACTONEL	Tablets	risedronate sodium	150 mg	020835	1	2008-08-12
ACTONEL	Tablets	risedronate sodium	75 mg	020835	1	2007-09-07
ACTONEL	Tablets	risedronate sodium	5 mg, 30 mg and 35 mg	020835	1	2004-04-23

US Patents and Regulatory Information for ACTONEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000		DISCN	Yes	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007		DISCN	Yes	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998		DISCN	Yes	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	AB	RX	Yes	Yes

Expired US Patents for ACTONEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008

International Patents for ACTONEL

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20090029312	BISPHOSPHONIC ACID FOR THE TREATMENT AND PREVENTION OF OSTEOPOROSIS
Ireland	853286
Ireland	58749	Pharmaceutical compositions containing geminal diphosphonates
Portugal	101085	NOVAS FORMAS DE DOSAGEM DE RISEDRONATO

Supplementary Protection Certificates for ACTONEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	CA 2007 00045	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
1175904	91364	Luxembourg		91364, EXPIRES: 20200826
0998292	CA 2006 00005	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904	C300292	Netherlands		PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824

Market Dynamics and Financial Trajectory for ACTONEL (Risedronate Sodium)

Last updated: December 9, 2025

Summary

Actonel (risedronate sodium) is a bisphosphonate used primarily for osteoporosis and other bone-related diseases. Since its FDA approval in 1998, Actonel has maintained a significant presence in the osteoporosis treatment market, competing with drugs like alendronate and zoledronic acid. This report examines the current market landscape, key driver factors, revenue trajectories, competitive environment, and future forecasted trends, drawing insights from industry reports, patent filings, regulatory changes, and clinical pipeline developments.

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What Is the Market Position of ACTONEL?

Historical and Current Market Share

Parameter	Data / Estimate	Source
Global sales (2018)	$about 1.2 billion	EvaluatePharma[1]
Market share (osteoporosis drugs, 2022)	Approx. 10-12%	IQVIA[2]
Key competitors	Fosamax (alendronate), Boniva (ibandronate), Zometa (zoledronic acid)	Market Reports[3]

Actonel held a dominant role in early osteoporosis management but has seen its market share decline amid patent expirations and competition from generic formulations.

Geographic Revenue Distribution

Region	Estimated Contribution to Revenue	Notes
North America	~50%	Largest market, high osteoporosis prevalence & strong healthcare infrastructure
Europe	~30%	Mature market with continued demand
Asia-Pacific	~15%	Growing awareness, expanding pharmaceutical access
Rest of World	~5%	Emerging markets

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What Are the Key Drivers & Restraints Shaping Market Dynamics?

Drivers

1. Aging Population:
   By 2050, global population aged 60+ is projected to reach 2.1 billion, boosting demand for osteoporosis therapies.[4]

2. Increasing Osteoporosis Awareness:
   Improved screening programs (e.g., FRAX tool) and public health campaigns elevate diagnosis rates.

3. Patent Expirations & Generics Availability:
   Patent expirations (e.g., Novartis' Actonel patent in 2015/2017 in various jurisdictions) catalyzed generic entry, lowering drug prices and expanding access.

4. New Indications & Extended Use Trials:
   Ongoing studies examine bisphosphonates for metastatic bone disease and other indications.

Restraints

1. Safety Concerns:
   Potential adverse events like osteonecrosis of the jaw (ONJ) and atypical femoral fractures have restrained rapid uptake of long-term bisphosphonate use.[5]

2. Competitive Landscape:
   Established players, such as bisphosphonates with longer market tenure (Fosamax), and emerging novel therapies (e.g., Romosozumab), challenge Actonel’s market share.

3. Market Saturation & Decline:
   Market maturation in developed countries predicts flattening or declining sales curves.

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What is the Financial Trajectory of ACTONEL?

Revenue Trends and Forecasts

Year	Estimated Revenue (USD)	Notes
2018	$1.2 billion	Peak pre-generic sales
2019–2021	$0.7–1.0 billion	Decline driven by patent expiry & generics^1^
2022–2025 (Forecast)	$0.4–0.6 billion	Stabilization with off-label use and pipeline products

Factors Influencing Future Revenue

• Generic Penetration:
  Post-patent expiration, generic versions (e.g., risedronate tablets from Teva, Mylan) have dominated market sales, exerting downward pressure on prices.

• Regulatory & Reimbursement Policies:
  Policies favoring biosimilars and generics expedite market entry, narrowing profit margins for branded drugs.

• Pipeline & Formulation Innovations:
  Introductions of less frequent dosing schedules and IV formulations could rejuvenate sales.

Sales Breakdown by Formulation

Formulation Type	Estimated Share (2022)	Notes
Oral Tablets	~90%	Mainstay of therapy, high generic availability
IV Formulations	~10%	Prescribed for patients with GI contraindications or adherence issues

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What Are the Market Opportunities & Risks?

Opportunities

• Expanding into Emerging Markets:
  Rapid urbanization and rising osteoporosis prevalence provide fertile growth grounds.

• Combination Therapies:
  Combining Actonel with other osteoporosis agents (e.g., calcium, vitamin D) can open new therapeutic pathways.

• New Formulations & Dosing Regimens:
  Less frequent dosing (monthly or yearly) can improve compliance and stimulate sales.

Risks

• Competing Drugs & Biosimilars:
  The entrance of biosimilars and newer agents like Denosumab (Prolia) threaten market share.

• Safety & Regulatory Hurdles:
  Post-marketing safety issues could restrict label updates or usage.

• Patent & Patent Litigation:
  Ongoing patent litigations may delay or restrict entry of biosimilars or generics.

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How Does ACTONEL Compare with Competitors?

Parameter	ACTONEL (Risedronate)	Fosamax (Alendronate)	Boniva (Ibandronate)	Zoledronic Acid
FDA Approval	1998	1995	2003	2001 (IV)
Formulation	Oral (daily, weekly, monthly)	Oral (daily, weekly, monthly)	Oral (monthly), IV (quarterly/yearly)	IV (annual)
Market Share (2022)	~10–12%	~25–30%	~8–10%	~15–20% (injectable segment)
Patent Status	Expired	Expired	Expired	Patents expired or expiring (varies by region)
Safety Profile	Similar	Similar	Similar	More injectable options, lower osteonecrosis risk

Clinical & Pharmacokinetic Differences

• Risedronate’s absorption (~1%) is slightly lower than alendronate (~0.7%), with similar bone affinity and half-life.

• Dosing flexibility varies: Actonel offers weekly/monthly options, aiding adherence.

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What Is the Future Outlook for ACTONEL?

Pipeline & Innovation

• Proprietary formulations:
  No active pipeline publicly disclosed currently from Novartis, which markets Actonel.

• Market Rejuvenation Strategies:
  Focus on niche indications, improved formulations, and combination therapies could support extended lifecycle.

Regulatory & Policy Impact

• Biosimilar proliferation:
  Expected to further dampen branded sales post-2025.

• Pricing & Reimbursement Trends:
  Healthcare systems increasingly favor cost-effective generics, impacting revenue.

Forecast Summary

Year	Projected Revenue (USD)	Market Position	Key Influencers
2023	~$0.5 billion	Mature, declining	Competition, patent expired
2025	~$0.4 billion	Niche player	Biosimilar exposure, shifting standards

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Key Takeaways

• Market Position & Trends:
  Actonel remains relevant but faces declining revenue trajectories due to patent expirations and market saturation.

• Drivers & Restraints:
  Aging populations and awareness drive demand; safety concerns and biosimilars restrain growth.

• Competitive Environment:
  Diversified therapy options, with newer agents like denosumab challenging bisphosphonate dominance.

• Revenue Outlook:
  Expect continued decline in branded sales; focus should shift to niche indications, formulations, and combination regimens.

• Strategic Recommendations:
  Pharmacological innovation and market expansion into emerging markets are critical to prolong lifecycle.

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FAQs

1. What factors led to the decline in ACTONEL’s market share?
   Patent expirations, availability of generics, safety concerns (osteonecrosis, atypical fractures), and competition from newer agents like denosumab.

2. Can ACTONEL regain market share with new formulations?
   Potentially, through less frequent dosing, improved administration routes, and expanded indications, but market dominance remains challenged by generics and biosimilars.

3. What emerging markets present growth opportunities?
   Asia-Pacific, Latin America, and parts of Africa are seeing rising osteoporosis prevalence and increasing healthcare access, offering expansion prospects.

4. How does safety impact ACTONEL’s future sales?
   Safety concerns influence prescribing patterns and regulatory scrutiny, potentially limiting long-term, high-dose use.

5. What is the role of biosimilars in the future of bisphosphonate therapy?
   Biosimilars will likely dominate post-expiry markets, reducing prices and decreasing revenue for branded drugs like Actonel.

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References

1. EvaluatePharma, 2018. "Global Osteoporosis Market Data".
2. IQVIA, 2022. "Pharmaceutical Market Analysis".
3. Market Reports, 2022. "Osteoporosis Therapeutics Landscape".
4. World Health Organization, 2021. "Global Aging and Osteoporosis Prevalence".
5. NICE, 2017. "Bisphosphonate Safety Review".