BONSITY Drug Patent Profile

Which patents cover Bonsity, and what generic alternatives are available?

Bonsity is a drug marketed by Alvogen and is included in one NDA.

The generic ingredient in BONSITY is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bonsity

A generic version of BONSITY was approved as teriparatide by APOTEX on November 16^th, 2023.

Summary for BONSITY

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	BONSITY at DailyMed

Pharmacology for BONSITY

Drug Class

Parathyroid Hormone Analog

US Patents and Regulatory Information for BONSITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	BONSITY	teriparatide	SOLUTION;SUBCUTANEOUS	211939-001	Oct 4, 2019		RX	No	No

EU/EMA Drug Approvals for BONSITY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
STADA Arzneimittel AG	Movymia	teriparatide	EMEA/H/C/004368 Movymia is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.	Authorised	no	yes	no	2017-01-11
Eli Lilly Nederland B.V.	Forsteo	teriparatide	EMEA/H/C/000425 Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.	Authorised	no	no	no	2003-06-10
Gedeon Richter Plc.	Terrosa	teriparatide	EMEA/H/C/003916 Terrosa is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.	Authorised	no	yes	no	2017-01-04
EuroGenerics Holdings B.V.	Qutavina	teriparatide	EMEA/H/C/005388 Qutavina is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.	Withdrawn	no	yes	no	2020-08-27

BONSITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Osteoporosis Drugs, Including BONSITY

Global Osteoporosis Drugs Market Overview

The global osteoporosis drugs market is experiencing significant growth, driven by several key factors. As of 2023, the market was valued at USD 14.74 billion and is projected to grow at a CAGR of 3.5% from 2024 to 2030[1][5].

Market Drivers

• Increasing Prevalence of Osteoporosis: The growing number of people suffering from osteoporosis, particularly in the geriatric population and postmenopausal women, is a major driver. This demographic shift is expected to create several opportunities for the market[1][5].
• Advancements in Drug Development: Ongoing research and development efforts aimed at creating more effective and safer osteoporosis drugs are fueling market growth. This includes the development of novel drug delivery systems and targeted therapies[5].
• Regulatory Approvals: Recent regulatory approvals for new osteoporosis treatments have significantly impacted the market. For example, the FDA approval of BONSITY, an injection indicated for patients at high risk of fracture, is expected to generate substantial revenue[4].

BONSITY: A New Player in the Market

Approval and Impact

BONSITY, developed by Pfenex Inc., received FDA approval in October 2019 for the treatment of osteoporosis in patients at high risk of fracture. This approval is a significant milestone, as it introduces a new treatment option that can help reduce the risk of fractures, a major concern for osteoporosis patients[4].

Market Positioning

BONSITY is part of the broader category of osteoporosis drugs that include bisphosphonates, parathyroid hormone therapy, calcitonin, selective estrogen receptor modulators (SERMs), and RANK ligand inhibitors. Given its recent approval, BONSITY is expected to contribute to the growth of the branded drugs segment, which dominates the market due to extensive marketing, brand loyalty, and governmental regulations[1].

Financial Trajectory

Revenue Projections

The global osteoporosis drugs market, including products like BONSITY, is projected to reach USD 15.08 billion by 2026 and further grow to approximately USD 18.9 billion by 2033. This growth is attributed to the increasing demand for effective osteoporosis treatments and the expanding aging population worldwide[4][5].

CAGR and Growth Rate

The market is expected to grow at a CAGR of 3.5% from 2023 to 2030 and 3.5% from 2023 to 2033. This consistent growth rate indicates a stable and expanding market for osteoporosis drugs, including BONSITY[1][5].

Distribution Channels

Retail Pharmacies

Retail pharmacies currently dominate the distribution channel segment, driven by the growing number of geriatric patients and age-related health conditions. However, online pharmacies are experiencing significant growth, with a CAGR of 5.2%, offering patients a practical and economical option for purchasing osteoporosis medications, including BONSITY[1].

Regional Outlook

North America and Europe

North America holds the highest market share due to the presence of several major pharmaceutical companies and a well-established healthcare system. Europe, particularly the UK, is also a significant market, driven by the rising prevalence of osteoporosis and the development of innovative therapies[1][4].

Asia Pacific

The Asia Pacific region is anticipated to witness growth at a CAGR of 4.1%, driven by demographic shifts, increased awareness of osteoporosis, and initiatives by health organizations and pharmaceutical companies[1].

Technological Trends and Innovations

Novel Drug Delivery Systems

The development of novel drug delivery systems, such as nanotechnology-based formulations and targeted drug delivery systems, is enhancing the bioavailability and efficacy of osteoporosis medications. These innovations are expected to improve patient outcomes and adherence[5].

Digital Health Solutions

Digital health solutions and telemedicine are expected to play a crucial role in patient monitoring and treatment adherence, providing better outcomes for those managing osteoporosis. This trend is likely to support the growth of the market, including the adoption of BONSITY[5].

Collaborations and Partnerships

Strategic alliances among pharmaceutical companies, research institutions, and healthcare organizations are essential for advancing research, drug development, and patient care in the field of osteoporosis. These collaborations can accelerate the development and market penetration of new treatments like BONSITY[5].

Key Takeaways

• The global osteoporosis drugs market is growing at a CAGR of 3.5% from 2023 to 2030.
• BONSITY, recently approved by the FDA, is expected to contribute significantly to the market growth.
• The market is driven by increasing prevalence, advancements in drug development, and regulatory approvals.
• Distribution channels are shifting towards online pharmacies, offering cost-effective and convenient options.
• Regional growth is significant in North America, Europe, and the Asia Pacific.

FAQs

1. What is the current market size of the global osteoporosis drugs market? The global osteoporosis drugs market was valued at USD 14.74 billion in 2023[1].

2. What is the projected CAGR for the osteoporosis drugs market from 2023 to 2030? The market is projected to grow at a CAGR of 3.5% from 2023 to 2030[1].

3. What are the key drivers of the osteoporosis drugs market? Key drivers include the increasing prevalence of osteoporosis, advancements in drug development, and recent regulatory approvals[1][5].

4. How does BONSITY fit into the osteoporosis drugs market? BONSITY is a recently approved injection indicated for patients at high risk of fracture, contributing to the growth of the branded drugs segment[4].

5. What role do online pharmacies play in the distribution of osteoporosis drugs? Online pharmacies are experiencing significant growth, offering patients a practical and economical option for purchasing osteoporosis medications, with a CAGR of 5.2%[1].

Cited Sources

1. Grand View Research: Osteoporosis Drugs Market Size And Share Report, 2030.
2. Wellmark: Teriparatide Policy.
3. BioSpace: Pharmacy Benefit Management Market Size to Reach USD 903.8 Billion by 2032.
4. Fortune Business Insights: Osteoporosis Treatment Market Size, Share & Industry Analysis.
5. GlobeNewswire: Osteoporosis Drugs Market is Projected to Develop at a CAGR of 3.5% from 2023 to 2033.