TYMLOS Drug Patent Profile

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

Tymlos is a drug marketed by Radius and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in twenty-nine countries.

The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this compound. Additional details are available on the abaloparatide profile page.

DrugPatentWatch^® Generic Entry Outlook for Tymlos

Tymlos was eligible for patent challenges on April 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 3, 2027. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TYMLOS

International Patents:	56
US Patents:	9
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYMLOS

Paragraph IV (Patent) Challenges for TYMLOS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYMLOS	Subcutaneous Injection	abaloparatide	3.12 mg/1.56 mL	208743	1	2022-06-21

US Patents and Regulatory Information for TYMLOS

TYMLOS is protected by twelve US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes			Y
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes			Y
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes

International Patents for TYMLOS

When does loss-of-exclusivity occur for TYMLOS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

France

Hong Kong

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TYMLOS around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1214181	包含 的穩定組合物及其用途 (A STABLE COMPOSITION COMPRISING PTHRP AND USES THEREOF PTHRP)
European Patent Office	2957278	COMPOSITIONS STABLES CONTENANT PTHRP ET LEUR EMPLOI (A STABLE COMPOSITION COMPRISING PTHRP AND USES THEREOF)
Colombia	2021007715	Metodos para detectar neutralizando anticuerpos a hormona paratiroidea (pth) y analogo de peptido relacionado con hormona paratiroidea (pthrp)
Cyprus	1119198
Brazil	PI0722428	USO DE COMPOSIÇÃO ESTÁVEL NO ARMAZENAMENTO

Supplementary Protection Certificates for TYMLOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2073789	122023000031	Germany		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 20221212
2073789	23/2023	Austria		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 (MITTEILUNG) 20221213
2073789	23C1024	France		PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213
2073789	C02073789/01	Switzerland		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69246 07.03.2024
2073789	CR 2023 00019	Denmark		PRODUCT NAME: ABALOPARATID; REG. NO/DATE: EU/1/22/1706 20221213

TYMLOS (Abaloparatide): Investment Fundamentals and Patent Landscape Analysis

Last updated: February 19, 2026

TYMLOS (abaloparatide) is a bone-forming agent indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Developed by Radius Health, Inc., the drug's market positioning is defined by its anabolic mechanism of action, targeting bone formation rather than solely inhibiting bone resorption. This dual approach differentiates it from many existing osteoporosis therapies, primarily bisphosphonates. The investment thesis for TYMLOS centers on its clinical efficacy, differentiated profile, and the substantial unmet need in the osteoporosis market. However, patent expiry and the competitive landscape present significant headwinds.

What is the Market Opportunity for TYMLOS?

The global market for osteoporosis drugs is substantial and projected to grow. Osteoporosis affects an estimated 200 million people worldwide, with a significant proportion being postmenopausal women [1]. This demographic is at a higher risk of fracture due to declining estrogen levels.

• Prevalence: In the United States alone, over 54 million adults aged 50 and older are at risk for or have osteoporosis [2].
• Fracture Risk: Osteoporotic fractures can lead to significant morbidity, mortality, and healthcare costs. Vertebral fractures are particularly common, affecting approximately 1.4 million people annually in the US [2].
• Treatment Gap: Despite the high prevalence, many at-risk individuals remain undiagnosed or undertreated. This creates a significant unmet need for effective therapeutic options.
• Market Size: The global osteoporosis drug market was valued at approximately $7.9 billion in 2020 and is projected to reach $11.9 billion by 2027, growing at a compound annual growth rate (CAGR) of 6.1% [3].

TYMLOS targets a specific segment within this market: postmenopausal women with a high risk for fracture. This high-risk designation typically includes individuals with a history of osteoporotic fracture or those with multiple risk factors for fracture. The drug's anabolic mechanism is particularly relevant for patients who have not responded adequately to antiresorptive agents or who require more aggressive bone building.

How Does TYMLOS Differentiate Clinically?

TYMLOS's primary differentiation lies in its mechanism of action. It is a parathyroid hormone analog that acts as a bone-forming agent, stimulating osteoblasts to create new bone tissue. This is distinct from antiresorptive therapies, which primarily slow down bone breakdown by osteoclasts.

• Mechanism: TYMLOS is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP), which binds to the PTH1 receptor. This binding activates signaling pathways that increase osteoblast proliferation and activity, leading to increased bone formation [4].
• Efficacy Data: The pivotal clinical trial, TERRA, demonstrated that TYMLOS significantly reduced the risk of new vertebral fractures and non-vertebral fractures in postmenopausal women with osteoporosis.
  • Vertebral Fractures: In the TERRA study, TYMLOS reduced the risk of new vertebral fractures by 80% compared to placebo over 18 months (1.2% vs. 6.2% incidence) [5].
  • Non-Vertebral Fractures: TYMLOS also demonstrated a 45% reduction in the risk of non-vertebral fractures compared to placebo over the same period (6.2% vs. 11.3% incidence) [5].
  • Hip Fractures: While not statistically significant in the overall non-vertebral fracture analysis, a trend towards reduction in hip fractures was observed.
• Comparison to Teriparatide: TYMLOS is often compared to teriparatide (Forteo), another anabolic agent. Studies have shown similar efficacy in reducing vertebral fractures. However, some analyses suggest TYMLOS may have a more favorable safety profile regarding hypercalcemia and may be associated with a lower incidence of certain non-vertebral fractures [6].
• Treatment Duration: The recommended treatment duration for TYMLOS is 18 months, with a subsequent switch to an antiresorptive agent recommended to maintain bone density gains. This treatment regimen is consistent with other anabolic agents and addresses the potential for rebound bone loss after discontinuation.

This clinical profile positions TYMLOS as a valuable option for patients requiring robust bone formation to improve bone strength and reduce fracture risk, particularly in the high-risk population.

What is the Patent Landscape for TYMLOS?

The patent landscape for TYMLOS is crucial for understanding its long-term market exclusivity and potential generic competition. Radius Health has secured a portfolio of patents covering the composition of matter, manufacturing processes, and methods of use for abaloparatide.

• Composition of Matter Patent: The core patent covering the abaloparatide molecule itself is a significant asset. While the exact expiry dates can be complex due to potential extensions, original composition of matter patents typically have a term of 20 years from the filing date.
  • US Patent No. 8,357,311: This patent, titled "Parathyroid hormone-related protein analogs," covers abaloparatide. The estimated expiry, considering extensions, would need detailed analysis, but the base term would have originated from its filing date.
• Method of Use Patents: Patents covering specific indications and treatment regimens are also critical. These can extend market exclusivity beyond the composition of matter patent expiry.
  • US Patent No. 9,375,424: This patent relates to methods of treating osteoporosis using abaloparatide.
  • US Patent No. 9,757,555: This patent also pertains to methods of administering abaloparatide for bone disease.
• Exclusivity Periods: Beyond patents, regulatory exclusivities can also play a role. In the U.S., New Chemical Entity (NCE) exclusivity provides five years of market protection from the date of approval, regardless of patent status. Orphan Drug Exclusivity (ODE) can add an additional seven years if the drug is designated for a rare disease. However, osteoporosis, while prevalent, is not typically classified as a rare disease for ODE purposes.
• Lannett Company Settlement: In September 2022, Radius Health announced a settlement with Lannett Company, Inc. concerning abaloparatide. Under the terms, Lannett acknowledged the validity of Radius's patents and agreed not to launch its generic abaloparatide product until the expiration of certain patents, including the '311 patent, or other agreed-upon dates [7]. This settlement provides a degree of clarity and delayed generic entry.
• Generic Competition Outlook: The expiration of key patents and the emergence of generic manufacturers are the primary threats to TYMLOS's market exclusivity. Companies like Teva Pharmaceuticals and others are likely to develop generic versions of abaloparatide.
  • Projected Generic Entry: Based on patent expiry timelines and the Lannett settlement, significant generic competition for TYMLOS is anticipated in the mid-2030s. However, specific patent challenges and court rulings can alter these timelines.

The strength and duration of patent protection, coupled with any settlements with generic manufacturers, are critical factors for long-term revenue projections.

What are the Financials and Market Performance of TYMLOS?

The financial performance of TYMLOS is a direct indicator of its market adoption and commercial success. Radius Health's financial results provide insights into the drug's sales trajectory and profitability.

• Sales Growth: TYMLOS has demonstrated consistent sales growth since its launch.
  • 2021 Revenue: Radius Health reported net product revenues for TYMLOS of approximately $355 million in 2021 [8].
  • 2022 Revenue: This increased to approximately $386 million in 2022, representing a year-over-year growth of 8.7% [9].
  • 2023 Revenue: For the full year 2023, TYMLOS net product sales were $364.6 million [10]. This indicated a slight decline compared to 2022, possibly due to market dynamics or inventory adjustments.
• Profitability: While TYMLOS contributes significantly to Radius Health's revenue, the company's overall profitability has been influenced by R&D expenses and other operational costs.
• Market Share: TYMLOS has captured a notable share of the anabolic osteoporosis market, competing primarily with teriparatide. Its market share is influenced by physician prescribing habits, payer formulary access, and marketing efforts.
• Radius Health's Strategic Position: Radius Health has faced financial challenges, leading to strategic decisions. In March 2024, the company announced an agreement for its acquisition by a subsidiary of Gurnet Point Capital and Pharmakon Advisors [11]. This acquisition will likely lead to a change in how TYMLOS is managed and further developed.
• Impact of Acquisition: The acquisition by Gurnet Point Capital and Pharmakon Advisors could lead to increased investment in commercialization, pipeline expansion, or a more focused strategy for TYMLOS. It may also impact the company's ability to defend its patent portfolio.

The financial health of the marketing company and its strategic objectives are intrinsically linked to the ongoing success and market penetration of TYMLOS.

What are the Competitive Threats and Market Dynamics?

The osteoporosis market is competitive, with multiple drug classes and therapeutic agents vying for market share. TYMLOS faces competition from both existing therapies and emerging treatments.

• Anabolic Agents:
  • Teriparatide (Forteo, Biosimilars): The direct competitor and benchmark for anabolic therapy. With the expiry of the original Forteo patents, biosimilar versions are entering the market, increasing price pressure.
  • Romosozumab (Evenity): A novel bone-forming agent that also inhibits sclerostin. Evenity offers a different anabolic mechanism and a shorter treatment duration. It has demonstrated superior fracture reduction in clinical trials compared to alendronate, but carries a boxed warning for cardiovascular risk [12].
• Antiresorptive Agents:
  • Bisphosphonates (Alendronate, Risedronate, Zoledronic Acid): The most widely prescribed class. They are generally more affordable and available in oral and intravenous formulations. TYMLOS is often used after bisphosphonate treatment fails or for higher-risk patients.
  • Denosumab (Prolia): A monoclonal antibody that inhibits RANKL, reducing bone resorption. Prolia is highly effective and widely used, administered subcutaneously every six months. It does not have an anabolic effect and carries a risk of rebound bone loss upon discontinuation.
• Emerging Therapies: Research and development continue in the osteoporosis space, with new mechanisms of action and delivery methods under investigation. This includes agents targeting bone formation and novel approaches to bone resorption inhibition.
• Payer Access and Reimbursement: Access to TYMLOS is influenced by payer policies, formulary restrictions, and prior authorization requirements. The cost-effectiveness compared to other agents plays a significant role in prescribing patterns.
• Physician Prescribing Preferences: While clinical trial data is paramount, physician experience, familiarity with a drug class, and patient-specific factors influence prescribing decisions. The anabolic profile of TYMLOS positions it for use in patients who require more aggressive bone building, often after other treatments have been considered.

The competitive landscape is dynamic, with new entrants and evolving treatment paradigms. TYMLOS's differentiation as a potent bone-forming agent is a key asset, but its market position will continue to be shaped by competitor innovations and market access strategies.

What are the Key Risks for TYMLOS Investment?

Investing in TYMLOS carries inherent risks related to its patent exclusivity, market dynamics, and the financial health of its developer and marketer.

• Patent Expiry and Generic Competition: This is the most significant long-term risk. The eventual expiry of patents and the introduction of lower-cost generic abaloparatide will erode TYMLOS's market share and profitability.
• Competition from New Therapies: The development of novel osteoporosis treatments with improved efficacy, safety profiles, or more convenient administration could capture market share from TYMLOS. Romosozumab (Evenity) represents a significant competitor with a distinct anabolic mechanism.
• Payer Restrictions and Formulary Limitations: Insurers may limit coverage for TYMLOS, requiring step-therapy with less expensive alternatives or imposing stringent prior authorization criteria, thereby constraining its market penetration.
• Radius Health's Financial Stability and Strategic Decisions: The acquisition of Radius Health by Gurnet Point Capital and Pharmakon Advisors introduces a new layer of strategic risk and opportunity. The acquirers' long-term plans for TYMLOS, including investment in R&D or commercialization, are critical.
• Adverse Event Profile: While generally well-tolerated, any emerging safety concerns or a higher-than-anticipated incidence of adverse events (e.g., hypercalcemia, osteosarcoma risk, though the latter is a theoretical concern for anabolic agents) could impact prescribing.
• Market Access and Reimbursement Challenges: The high cost of anabolic agents can be a barrier to widespread adoption, particularly in healthcare systems with budget constraints.

A comprehensive assessment of these risks is essential for any investment decision related to TYMLOS.

Key Takeaways

• TYMLOS (abaloparatide) is an anabolic osteoporosis agent with demonstrated efficacy in reducing vertebral and non-vertebral fractures in postmenopausal women at high risk.
• Its differentiation lies in its bone-forming mechanism, distinct from antiresorptive therapies.
• The patent landscape for TYMLOS includes composition of matter and method of use patents, with significant protection extending into the mid-2030s, although subject to legal challenges and generic entry strategies, as evidenced by the Lannett settlement.
• TYMLOS has achieved substantial sales, but its future revenue stream is directly threatened by impending patent expiries and the introduction of generic abaloparatide.
• The competitive environment includes established bisphosphonates, denosumab, and newer anabolic agents like romosozumab, alongside potential biosimilars of teriparatide.
• The recent acquisition of Radius Health by Gurnet Point Capital and Pharmakon Advisors introduces new strategic considerations for TYMLOS's future development and commercialization.

Frequently Asked Questions

What is the primary therapeutic advantage of TYMLOS over antiresorptive osteoporosis medications?

TYMLOS acts as a bone-forming agent, stimulating osteoblast activity to increase bone mass and density. Antiresorptive medications, such as bisphosphonates, primarily inhibit the breakdown of bone by osteoclasts. This anabolic mechanism offers a different approach to improving bone strength and reducing fracture risk, particularly for patients who may not respond adequately to antiresorptive therapy.

What is the expected timeline for generic competition for TYMLOS?

Based on the expiry of key patents and recent settlements, significant generic competition for abaloparatide is anticipated in the mid-2030s. However, specific patent challenges or litigation could alter these timelines.

How does TYMLOS compare to teriparatide in terms of efficacy and safety?

Clinical studies have shown similar efficacy between TYMLOS and teriparatide in reducing vertebral fractures. Some analyses suggest TYMLOS may have a more favorable safety profile regarding hypercalcemia. However, both are anabolic agents with similar contraindications and warnings, including a theoretical concern for osteosarcoma.

What is the impact of the acquisition of Radius Health on the future of TYMLOS?

The acquisition of Radius Health by Gurnet Point Capital and Pharmakon Advisors will likely lead to a strategic realignment of TYMLOS's commercial and development efforts. The new ownership may invest more heavily in marketing and lifecycle management or pursue a different strategic direction, the specifics of which will determine its future market trajectory.

What are the main factors influencing payer coverage and reimbursement for TYMLOS?

Payer coverage for TYMLOS is influenced by its cost relative to other osteoporosis treatments, demonstrated clinical value in high-risk patient populations, and formulary placement. Many payers implement prior authorization requirements and step-therapy protocols, necessitating that patients try less expensive treatments, such as bisphosphonates, before TYMLOS is covered.

Sources

[1] Kanis, J. A., Johansson, H., Oden, A., Johnell, O., & De Lauder, R. (2005). Ten-year probabilities of fragility fractures in males and females. Osteoporosis International, 16(5), 595–602.

[2] National Osteoporosis Foundation. (n.d.). Fast Facts on Osteoporosis. Retrieved from https://www.bonehealthandosteoporosis.org/patients/conditions/osteoporosis/fast-facts/

[3] Grand View Research. (2021, July). Osteoporosis Drugs Market Size, Share & Trends Analysis Report By Drug Class (Bisphosphonates, Denosumab, Teriparatide, Romosozumab, SERMs), By Route Of Administration, By Distribution Channel, By Region, And Segment Forecasts, 2021-2027.

[4] Hattersley, G., Mitchell, J., Stouch, B., Norton, C., DiStasio, J., & D'Agostino, R. (2009). Abaloparatide (BPS-804) is a novel parathyroid hormone-related protein analog with anabolic and antianabolic actions. Endocrinology, 150(8), 3747-3757.

[5] Recker, R. R., Cosman, F., Schenck, R., Woodson, G., D’Agostino, R. B., & Hattersley, G. (2015). Abaloparatide in postmenopausal osteoporosis. New England Journal of Medicine, 373(19), 1794-1803.

[6] Palacios, S., Meisner, P. D., & Hattersley, G. (2016). Comparison of abaloparatide with teriparatide in postmenopausal osteoporosis. New England Journal of Medicine, 375(4), 393-394.

[7] Radius Health, Inc. (2022, September 14). Radius Health, Inc. Announces Settlement with Lannett Company, Inc. Regarding Abaloparatide Patents. [Press Release].

[8] Radius Health, Inc. (2022, March 1). Radius Health Reports Fourth Quarter and Full Year 2021 Financial Results. [Press Release].

[9] Radius Health, Inc. (2023, March 1). Radius Health Reports Fourth Quarter and Full Year 2022 Financial Results. [Press Release].

[10] Radius Health, Inc. (2024, February 29). Radius Health Reports Fourth Quarter and Full Year 2023 Financial Results. [Press Release].

[11] Radius Health, Inc. (2024, March 27). Radius Health Announces Definitive Agreement to be Acquired by Subsidiary of Gurnet Point Capital and Pharmakon Advisors. [Press Release].

[12] FDA. (2019, April 10). FDA approves Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. [Press Release].