actonel Drug Patent Profile

When do Actonel patents expire, and what generic alternatives are available?

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:	87
Clinical Trials:	35
Patent Applications:	2,193
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
Warner Chilcott	ACTONEL WITH CALCIUM (COPACKAGED)	calcium carbonate; risedronate sodium	TABLET;ORAL	021823-001	Aug 12, 2005		DISCN	Yes	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008	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	020835-004	Apr 16, 2007
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998

International Patents for actonel

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1024166
Japan	2005255687	COMPOSITION RETARDING RELEASE OF RISEDRONATE
South Korea	20150053811	골다공증 치료 및 예방용 비스포스폰산 (BISPHOSPHONIC ACID FOR THE TREATMENT AND PREVENTION OF OSTEOPOROSIS)
South Africa	8509694
China	1299689
Cyprus	1108105
Japan	2013067642	FILM-COATED TABLET FOR IMPROVED UPPER GASTROINTESTINAL TRACT SAFETY

Supplementary Protection Certificates for actonel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0998292	91222	Luxembourg		91222, EXPIRES: 20200824
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
1175904	C01175904/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
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
1175904	CA 2007 00045	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
1175904	91364	Luxembourg		91364, EXPIRES: 20200826

Actonel Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACTONEL

Introduction to ACTONEL

ACTONEL, also known as risedronate sodium, is a medication used in the treatment and prevention of osteoporosis. It is part of the bisphosphonate class of drugs, which are widely used to increase bone mass and reduce the risk of fractures.

Market Size and Growth

The global osteoporosis drugs market, within which ACTONEL operates, is projected to experience significant growth. As of 2022, the global osteoporosis drugs market was valued at USD 8.9 billion and is expected to reach USD 12.12 billion by 2031, growing at a CAGR of 3.5% during the forecast period[1].

Regional Market Performance

North America

North America, particularly the U.S., dominates the osteoporosis drugs market, including ACTONEL. This region's strong medical and healthcare infrastructure, along with substantial investments in healthcare and favorable R&D policies, contribute to its market dominance. The U.S. market is driven by high disposable income, enabling easy access to osteoporosis treatments[4].

Europe

Europe is the second-largest market for osteoporosis drugs, with a CAGR of 3.4% expected during the forecast period. The presence of major pharmaceutical companies like Hoffmann-La Roche Ltd. and Novartis International AG, along with increasing awareness and prevalence of osteoporosis, drives the market growth in this region[1].

Asia-Pacific

The Asia-Pacific region, including countries like China, Japan, and India, is expected to witness significant growth due to an aging population, increased healthcare expenditure, and rising awareness of osteoporosis. China, in particular, is driving market growth with government support for healthcare infrastructure enhancement[4].

Drug Class and Market Share

Bisphosphonates

ACTONEL falls under the bisphosphonate segment, which dominates the global osteoporosis drugs market. Bisphosphonates, including drugs like Fosamax, Boniva, Actonel, Reclast, alendronate, and Zometa, hold the majority share due to their widespread use and the presence of major players investing in R&D for advanced bisphosphonates[1].

Approval and Clinical Trials

ACTONEL has received several FDA approvals that have expanded its market reach:

• Approval for Men: In 2006, ACTONEL was approved for the treatment of osteoporosis in men, based on a two-year clinical trial that showed significant improvements in lumbar spine bone mineral density and reductions in bone turnover markers[2].
• Once-a-Week and Once-a-Month Dosing: ACTONEL has been approved in various dosing regimens, including once-a-week (35 mg) and once-a-month (150 mg) doses. These approvals have been based on clinical trials that demonstrated similar efficacy to daily dosing regimens while offering greater convenience to patients[2][5].

Safety and Tolerability

Clinical trials have shown that ACTONEL is generally well tolerated. The most commonly reported adverse events include constipation, back pain, arthralgia, influenza, and nasopharyngitis. These adverse events are comparable to those seen in placebo groups, indicating a favorable safety profile[2][3].

Market Drivers

• Growing Prevalence of Osteoporosis: The increasing prevalence of osteoporosis, particularly among the geriatric population and postmenopausal women, drives the demand for osteoporosis drugs like ACTONEL[4].
• R&D Activities: Continuous R&D activities focused on launching new drugs and improving existing ones, such as the approval of new dosing regimens for ACTONEL, contribute to market growth[1].
• Government Regulations and Awareness: Government initiatives and regulations promoting the use of generic and cost-effective drugs, along with rising awareness among healthcare providers and patients, also fuel the market[4].

Challenges and Restraints

• Safety Concerns: Long-term use of bisphosphonates, including ACTONEL, is associated with safety concerns such as atypical femur fractures, which can restrict market growth[1].
• Market Saturation: In regions like North America and Europe, the market is somewhat saturated, leading to slower growth rates compared to emerging markets[1].

Financial Trajectory

The financial trajectory of ACTONEL is closely tied to the overall osteoporosis drugs market. Here are some key financial indicators:

• Revenue Growth: The osteoporosis drugs market, which includes ACTONEL, is expected to grow from USD 8.9 billion in 2022 to USD 12.12 billion by 2031, at a CAGR of 3.5%[1].
• Generic Competition: As patents for branded drugs like ACTONEL expire, generic versions are becoming more prevalent, which can impact the revenue of branded drugs but also provide cost-effective alternatives to patients[4].

Key Takeaways

• Market Growth: The osteoporosis drugs market, including ACTONEL, is expected to grow significantly driven by increasing prevalence and R&D activities.
• Regional Performance: North America and Europe are dominant markets, while Asia-Pacific is expected to show rapid growth.
• Safety and Efficacy: ACTONEL has a favorable safety profile and has been approved in various dosing regimens.
• Challenges: Safety concerns and market saturation in certain regions are key challenges.

FAQs

Q: What is the current market size of the osteoporosis drugs market? A: The global osteoporosis drugs market was valued at USD 8.9 billion in 2022[1].

Q: What is the expected CAGR for the osteoporosis drugs market? A: The market is expected to grow at a CAGR of 3.5% from 2023 to 2031[1].

Q: Which region dominates the osteoporosis drugs market? A: North America, particularly the U.S., dominates the market due to its advanced healthcare infrastructure and high disposable income[4].

Q: What are the common adverse events associated with ACTONEL? A: Common adverse events include constipation, back pain, arthralgia, influenza, and nasopharyngitis[2][3].

Q: Why is the Asia-Pacific region expected to show significant growth in the osteoporosis drugs market? A: The region is driven by an aging population, increased healthcare expenditure, and rising awareness of osteoporosis, particularly in countries like China and Japan[4].

Sources:

1. Straits Research: Osteoporosis Drugs Market Size to Reach $12.12 billion by 2031[1].
2. Sanofi US: The U.S. Food and Drug Administration approves ACTONEL® for treatment to increase bone mass in men with osteoporosis[2].
3. BioSpace: P&G, Sanofi Aventis: The U.S. Food And Drug Administration Approves ACTONEL with Calcium[3].
4. Grand View Research: Osteoporosis Drugs Market Size And Share Report, 2030[4].
5. Sanofi US: FDA Approves New Once-A-Month Dose Of ACTONEL®[5].