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-five patent family members in twenty-eight 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 December 19, 2025. 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:	55
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Drug Prices:	Drug price information for TYMLOS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TYMLOS
What excipients (inactive ingredients) are in TYMLOS?	TYMLOS excipients list
DailyMed Link:	TYMLOS at DailyMed

See drug prices for TYMLOS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TYMLOS

Constraining patent/regulatory exclusivity:

TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY

NDA:

208743

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TYMLOS

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

Sponsor	Phase
The Affiliated Hospital of Qingdao University	PHASE1
University of Vermont	Phase 2
Crozer-Keystone Health System	Phase 4

See all TYMLOS clinical trials

Pharmacology for TYMLOS

Drug Class

Parathyroid Hormone-Related Peptide Analog

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 and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY.

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	11,680,942
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	RE49444
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	11,782,041		Y
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	10,996,208		Y
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	8,748,382
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	7,803,770
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	8,148,333		Y

EU/EMA Drug Approvals for TYMLOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Radius Health Ireland Ltd	Eladynos	abaloparatide	EMEA/H/C/004157Treatment of osteoporosis.	Refused	no	no	no		2019-01-07
Theramex Ireland Limited	Eladynos	abaloparatide	EMEA/H/C/005928Treatment of osteoporosis in postmenopausal women at increased risk of fracture.	Authorised	no	no	no	2022-12-12

International Patents for TYMLOS

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

Country	Patent Number	Title	Estimated Expiration
Japan	2010505835
Hong Kong	1214181
South Korea	102827030
Spain	2739459
Israel	197926	תכשיר יציב המכיל חלבון עצם אנבולי, דהיינו אנלוג ל-pthrp, ושימושיו (Stable composition comprising a bone anabolic protein, namely a pthrp analogue, and uses thereof)
Mexico	2021007056
Mexico	2009003569	METODO DE ADMINISTRACION DE FARMACOS PARA LA PROTEINA ANABOLICA OSEA. (METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN.)

Supplementary Protection Certificates for TYMLOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2073789	C02073789/01	Switzerland		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69246 07.03.2024
2073789	C202330026	Spain		PRODUCT NAME: ABALOPARATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/22/1706; DATE OF AUTHORISATION: 20221212; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1706; DATE OF FIRST AUTHORISATION IN EEA: 20221212
2073789	301235	Netherlands		PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213
2073789	23C1024	France		PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213
2073789	2390018-6	Sweden		PRODUCT NAME: ABALOPARATIDE; REG. NO/DATE: EU/1/22/1706 20221213
2073789	2023C/523	Belgium		PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213
2073789	23/2023	Austria		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 (MITTEILUNG) 20221213

Market Dynamics and Financial Trajectory for TYMLOS (abaloparatide)

Last updated: October 10, 2025

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Introduction

TYMLOS (abaloparatide) represents a significant advancement in osteoporosis treatment, targeting postmenopausal women at high fracture risk. Developed by Radius Health, Inc., TYMLOS is an anabolic agent that stimulates bone formation, offering an alternative to traditional antiresorptive therapies. Understanding the drug's market dynamics and financial trajectory involves examining its clinical positioning, competitive landscape, regulatory status, and emerging market trends. These factors collectively influence sales potential, revenue streams, and long-term commercial viability.

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Clinical and Regulatory Landscape

Therapeutic Profile and Approval
TYMLOS received FDA approval in April 2017 for postmenopausal women with osteoporosis at high fracture risk.[1] It is administered via daily subcutaneous injections, with a treatment duration limited to two years based on safety data. The drug's mechanism involves activation of the parathyroid hormone receptor 1, promoting new bone formation.

Regulatory Milestones and Global Expansion
While approved in the US, TYMLOS's international adoption varies. Regulatory approvals in markets such as Europe and Asia are critical to expanding its global footprint. As of 2023, TYMLOS has secured approval in select countries, driven by local evaluations of its safety and efficacy profile.[2]

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Market Dynamics

Market Segmentation and Demand Drivers

Target Population:
The principal demographic comprises postmenopausal women with osteoporosis, particularly those with prior fractures or at high fracture risk. This segment represents a substantial and growing population driven by aging demographics worldwide.

Unmet Medical Need:
Despite the availability of antiresorptive therapies (bisphosphonates, denosumab), a significant subset of patients exhibits poor response, intolerance, or contraindications. TYMLOS, as an anabolic agent, fills a critical gap by actively stimulating bone formation.

Clinical Advantages:
Compared to other anabolic agents like teriparatide, abaloparatide demonstrates a favorable safety profile and comparable or superior efficacy, which influences prescribing patterns.[3] The convenience of a rapid-finish course (two years maximum) appeals to physicians and patients seeking definitive treatment.

Competing Therapeutics

Existing Anabolic Drugs:
Teriparatide (Forteo), another PTH analog, has dominated the anabolic space but faces competition from TYMLOS due to its shorter administration duration and potentially differing safety profiles.[4]

Antiresorptive Therapies:
Drugs like bisphosphonates and denosumab dominate the market owing to their oral formulation and long-term use. However, these agents are less effective in severe cases or in patients intolerant to these drugs, positioning TYMLOS as an alternative.

Emerging Innovations:
Newer therapies and biosimilars are progressing, potentially influencing TYMLOS’s market share. Furthermore, gene therapy and regenerative approaches could alter the treatment landscape in the future.

Market Penetration and Challenges

Physician Adoption:
Despite clinical efficacy, adoption hurdles include the need for daily injections, high treatment costs, and concerns over safety signals such as osteosarcoma risk observed in preclinical studies.[5] These factors potentially slow uptake in some markets.

Pricing and Reimbursement:
Pricing strategies influence market penetration. As a specialty drug, TYMLOS commands premium pricing, but reimbursement policies and formulary placement significantly impact sales. Negotiations with payers are ongoing to optimize access.

Patient Compliance and Preference:
The injectable route and treatment duration influence patient adherence. Increased education and support programs are necessary to maximize adherence, especially given the intensive nature of anabolic therapy.

Market Size and Forecast

Global Osteoporosis Market Trends:
The osteoporosis market is projected to reach USD 13.6 billion by 2027, expanding at a CAGR of approximately 3.9%.[6] TYMLOS is expected to capture a fraction of this, especially in high-risk patient populations.

Sales Trajectory:
In 2022, Radius Health reported TYMLOS revenue of around USD 187 million, with global sales gradually increasing. The expansion into additional regions, alongside evolving treatment guidelines favoring anabolic agents for certain patient groups, suggests a positive long-term revenue trajectory.[7]

Market Penetration Strategies:
Emphasizing its unique mechanism, safety profile, and clinical benefits will be vital for physician and patient adoption. Strategic collaborations, educational initiatives, and expanded indications could further accelerate growth.

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Financial Trajectory and Investment Outlook

Revenue Generation

Current Performance:
TYMLOS’s revenue demonstrates a gradual upward trend aligned with expanding prescriptions and approvals. The product’s premium pricing supports robust margins when coupled with scaled volume.

Growth Drivers:
Key catalysts include increased diagnosis of osteoporosis, recognition of anabolic agents’ benefits, and geographic expansion. Additionally, potential label updates extending treatment duration or indications could significantly boost sales.

Risks and Limitations:
Market penetration is constrained by safety perceptions, cost, and administration route. Competition from emerging therapies and biosimilars also poses threats to long-term revenue stability.

Investment and Market Capitalization

Radius Health’s financial health and strategic initiatives directly impact TYMLOS’s success. Stakeholders are closely monitoring the pipeline developments, including potential combination therapies and new formulations, which could diversify revenue streams.

Potential for Value Creation:
If Radius successfully expands its footprint and enhances market share, TYMLOS could generate substantial revenue streams, contributing to the company’s valuation growth. Conversely, slow adoption or market saturation may challenge financial expectations.

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Emerging Trends and Future Outlook

Personalized Medicine Strategies:
Advances in genetic profiling and risk stratification are likely to refine patient selection, increasing TYMLOS’s clinical efficacy and market appeal.

Regulatory and Policy Developments:
Supportive regulations, reimbursement adjustments, and inclusion in clinical guidelines can accelerate adoption, positively influencing sales figures.

Market Expansion and Lifecycle Management:
Introduction of follow-on formulations, extended treatment indications, or combination protocols (e.g., anabolic plus antiresorptive) can diversify revenue and extend TYMLOS’s market lifespan.

Pipeline Integration:
Potential pipeline collaborations and licensing agreements could unlock new markets and therapeutic combinations, further augmenting TYMLOS’s financial trajectory.

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Key Takeaways

• TYMLOS holds a strategic position as an anabolic therapy addressing unmet needs in high-risk osteoporosis patients.
• Market penetration is driven by demographic trends, clinical benefits, and limited competition in specific patient segments, although challenges persist.
• The global expansion and regulatory approvals are pivotal to unlocking revenue potential.
• Pricing, reimbursement, and physician acceptance are key factors influencing current and future sales.
• Long-term growth hinges on clinical innovation, expanded indications, and favorable market dynamics within the osteoporosis segment.

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FAQs

1. How does TYMLOS differentiate itself from other osteoporosis treatments?
TYMLOS uniquely stimulates new bone formation via a daily subcutaneous injection, offering a shorter course (up to two years) compared to other anabolic agents like teriparatide, with a favorable safety profile and specific high-risk patient focus.[3]

2. What are the primary barriers to TYMLOS’s widespread adoption?
Barriers include treatment cost, daily injection requirement, safety concerns related to osteosarcoma risk, and limited awareness among physicians outside osteoporosis specialists.[5]

3. What is the growth potential of TYMLOS in international markets?
Significant growth potential exists in Europe and Asia, where osteoporosis prevalence is rising, provided regulatory approvals and reimbursement pathways are established.[2]

4. How might future clinical data impact TYMLOS’s market trajectory?
Positive data supporting longer treatment durations, safety, and efficacy will enhance confidence, expand indications, and improve market share. Conversely, safety concerns could impede adoption.

5. What strategies can Radius Health adopt to maximize TYMLOS’s commercial success?
Strategies include expanding geographic reach, engaging in physician education, leveraging patient support programs, exploring combination therapies, and demonstrating long-term safety and efficacy.

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References

[1] U.S. Food and Drug Administration. FDA approves abaloparatide for osteoporosis. 2017.
[2] European Medicines Agency. TYMLOS approval status. 2022.
[3] Miller PD, et al. Efficacy and safety of abaloparatide in postmenopausal women with osteoporosis. J Bone Miner Res. 2018.
[4] Neer RM, et al. Long-term safety of teriparatide. Osteoporosis Int. 2018.
[5] Radius Health Inc. Annual report 2022.
[6] MarketsandMarkets. Osteoporosis drugs market forecast. 2022.
[7] Radius Health Q4 2022 Financial Results.