BINOSTO Drug Patent Profile

Which patents cover Binosto, and when can generic versions of Binosto launch?

Binosto is a drug marketed by Radius and is included in one NDA. There is one patent protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in BINOSTO is alendronate sodium. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Binosto

A generic version of BINOSTO was approved as alendronate sodium by APOTEX on August 4^th, 2008.

Summary for BINOSTO

International Patents:	20
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	3
Patent Applications:	82
Drug Prices:	Drug price information for BINOSTO
What excipients (inactive ingredients) are in BINOSTO?	BINOSTO excipients list
DailyMed Link:	BINOSTO at DailyMed

See drug prices for BINOSTO

Recent Clinical Trials for BINOSTO

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
Doris Duke Charitable Foundation	Phase 2
University of California, Davis	Phase 2

See all BINOSTO clinical trials

Pharmacology for BINOSTO

Drug Class

Bisphosphonate

US Patents and Regulatory Information for BINOSTO

BINOSTO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012		RX	Yes	Yes	9,592,195		Y

Expired US Patents for BINOSTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012	7,488,496
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012	7,964,212

International Patents for BINOSTO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004035004
World Intellectual Property Organization (WIPO)	03075884
Spain	2448501
Malaysia	166971	STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS
South Korea	102011505
Canada	2495886	COMPOSITIONS EFFERVESCENTES CONTENANT DES BISPHOSPHONATES ETMETHODES CONNEXES (EFFERVESCENT COMPOSITIONS COMPRISING BISPHOSPHONATES AND METHODS RELATED THERETO)
World Intellectual Property Organization (WIPO)	2012078528

Supplementary Protection Certificates for BINOSTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826

BINOSTO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BINOSTO

Introduction to BINOSTO

BINOSTO®, developed by EffRx Pharmaceuticals SA, is a groundbreaking treatment for osteoporosis, offering a unique buffered effervescent solution that addresses the limitations of traditional oral bisphosphonates. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Market Need and Target Audience

Osteoporosis is a widespread condition affecting over 200 million people globally, with a significant presence in the 7 major markets. The global osteoporosis market is estimated to be around USD 10 billion and is growing, particularly in emerging markets[4].

BINOSTO® is specifically designed for patients who have difficulty swallowing tablets, a common issue affecting up to 40% of American adults according to a Harris Interactive Poll. This targeted approach fills an important unmet need in the osteoporosis treatment market[4].

Regulatory Approvals and Launch

BINOSTO® has received regulatory approvals in several key markets. In the United States, it was approved by the FDA in 2012 for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis[2][4].

In addition to the U.S., BINOSTO® is available by prescription in countries such as Italy, Spain, Portugal, the UK, and South Korea. The drug has also gained regulatory clearance in over 50 countries and is in the process of expanding its global footprint[1][3].

Commercialization and Partnerships

EffRx Pharmaceuticals has formed strategic partnerships to enhance the commercialization of BINOSTO®. In the United States, EffRx initially partnered with Mission Pharmacal for distribution. However, in 2023, EffRx signed an exclusive licensing and distribution agreement with Radius Health, Inc., a major player in the U.S. bone health market. This partnership is expected to leverage Radius's established presence and expertise to further grow BINOSTO®'s market share[5].

In other regions, such as South Korea, BINOSTO® is marketed by Ahn-Gook Pharmaceutical, which has a strong local sales presence and expertise. This partnership has been instrumental in capturing a significant share of the Korean market, valued at around $115 million, with alendronate accounting for more than 90% of it[1].

Market Performance and Uptake

The initial uptake of BINOSTO® has been promising. In Europe, the drug saw almost half a million monthly prescriptions in its first year, indicating strong acceptance by the healthcare community[1].

In the U.S., the partnership with Radius Health is expected to drive further growth, given Radius's success with its other osteoporosis treatment, TYMLOS®. The addition of BINOSTO® to Radius's portfolio is anticipated to expand its offerings to healthcare providers and support the needs of the approximately 10 million people in the U.S. living with osteoporosis[5].

Financial Trajectory

The financial trajectory of BINOSTO® is influenced by several factors, including its unique formulation, regulatory approvals, and strategic partnerships.

• Revenue Growth: With its expanding global footprint and strong partnerships, BINOSTO® is poised for significant revenue growth. The drug's success in Europe and its potential in the U.S. market, particularly through the partnership with Radius Health, are key drivers of this growth.

• Market Share: BINOSTO®'s ability to address the unmet need of patients with swallowing difficulties positions it to capture a substantial share of the osteoporosis treatment market. In South Korea, for example, it is expected to overcome the limitations of oral bisphosphonates and improve patient adherence, thereby increasing its market share[1].

• Patent Protection: EffRx holds patents for BINOSTO® that provide exclusivity until February 2023, with additional patents pending. This patent protection is crucial for maintaining a competitive edge and ensuring continued revenue streams[2][4].

Competitive Landscape

BINOSTO® operates in a competitive osteoporosis treatment market, but its unique formulation sets it apart. Here are some key competitive aspects:

• Unique Formulation: BINOSTO® is the first and only buffered effervescent solution for osteoporosis, making it an attractive option for patients who struggle with traditional tablets. This differentiation helps in capturing market share and driving patient adherence[3].

• Competitive Partnerships: The partnership with Radius Health in the U.S. and other regional partners like Ahn-Gook Pharmaceutical in South Korea enhances BINOSTO®'s competitive position by leveraging the partners' established market presence and expertise[1][5].

Patient Adherence and Outcomes

BINOSTO®'s design aims to improve patient adherence, a critical factor in the long-term management of osteoporosis.

• Ease of Use: The effervescent tablet dissolves in water to form a buffered solution, eliminating the risk of the tablet getting lodged in the esophagus and making it easier for patients to take their medication[3].

• Fracture Risk Reduction: BINOSTO® provides gold standard fracture-risk reduction, similar to other alendronate treatments, but with the added benefit of improved adherence. This can lead to better patient outcomes and reduced healthcare costs associated with fractures[1][3].

Key Takeaways

• Innovative Formulation: BINOSTO® is the first and only buffered effervescent solution for osteoporosis, addressing the needs of patients with swallowing difficulties.
• Strong Regulatory Approvals: Approved in multiple countries, including the U.S., Europe, and South Korea.
• Strategic Partnerships: Partnerships with Mission Pharmacal, Ahn-Gook Pharmaceutical, and Radius Health enhance commercialization efforts.
• Promising Market Uptake: Strong initial uptake in Europe and potential for growth in the U.S. market.
• Financial Growth: Poised for revenue growth due to expanding global footprint and strong partnerships.
• Competitive Edge: Unique formulation and patent protection maintain a competitive edge.

FAQs

Q: What is BINOSTO® and how does it differ from other osteoporosis treatments? BINOSTO® is a buffered effervescent solution containing alendronate, designed for patients who have difficulty swallowing tablets. It dissolves in water to form a buffered solution, reducing the risk of esophageal and stomach exposure to acidified alendronate[3].

Q: Which markets is BINOSTO® currently available in? BINOSTO® is available by prescription in the United States, Italy, Spain, Portugal, the UK, and South Korea, among other countries. It has regulatory clearance in over 50 countries and is expanding its global footprint[1][3].

Q: What are the key benefits of BINOSTO® for patients? BINOSTO® offers improved adherence to therapy due to its easy-to-swallow formulation, reduces the risk of fractures, and provides a pleasant-tasting solution, making it a patient-friendly option[3][4].

Q: Who are the key partners involved in the commercialization of BINOSTO®? EffRx Pharmaceuticals has partnered with Mission Pharmacal for initial U.S. distribution, Ahn-Gook Pharmaceutical for the South Korean market, and recently signed an exclusive licensing agreement with Radius Health for the U.S. market[1][2][5].

Q: What is the financial outlook for BINOSTO®? BINOSTO® is poised for significant revenue growth due to its expanding global footprint, strong partnerships, and unique formulation that addresses an unmet need in the osteoporosis treatment market[1][5].

Sources

1. EffRx: First-In-Class Osteoporosis Treatment Binosto Launches In South Korea - Biospace
2. BINOSTO™ - First and Only Buffered Effervescent Solution for the Treatment of Osteoporosis Launched in the USA - PR Newswire
3. Binosto® – EffRx Pharmaceuticals SA - EffRx Pharmaceuticals
4. FDA Approves EffRx's BINOSTO®, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution - Biospace
5. EffRx Pharmaceuticals Signs Exclusive Licensing Agreement With Radius Health To Commercialize BINOSTO® In The United States - Business Wire