TYMLOS Drug Patent Profile

Which patents cover Tymlos, 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
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

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
Jacqueline Kernaghan	Phase 4
David Lunardini	Phase 2

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.

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

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

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
China	102274492
China	113286818
Denmark	2073789
World Intellectual Property Organization (WIPO)	2020144653
Cyprus	1119198

Supplementary Protection Certificates for TYMLOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2023 00019	Denmark		PRODUCT NAME: ABALOPARATID; REG. NO/DATE: EU/1/22/1706 20221213
2073789	23C1024	France		PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213
2073789	LUC00309	Luxembourg		PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213

TYMLOS (Abaloparatide) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is TYMLOS and its Therapeutic Application?

TYMLOS, an injectable anabolic agent, is the brand name for abaloparatide. It is manufactured by Radius Health, Inc. and is approved by the U.S. Food and Drug Administration (FDA) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. This risk is defined by the presence of a history of osteoporotic fracture, multiple risk factors for fracture, or when the patient has failed or is intolerant to alternative osteoporotic therapies [1]. Abaloparatide functions by stimulating bone formation through activation of the parathyroid hormone (PTH) receptor 1, thereby increasing bone mineral density and reducing the risk of vertebral and non-vertebral fractures [2].

What is the Patent Landscape for TYMLOS?

The patent landscape for TYMLOS is characterized by a primary composition of matter patent and a series of secondary patents covering its manufacturing, formulation, and methods of use. The U.S. Patent No. 8,575,316, covering the abaloparatide compound itself, was initially set to expire in 2027. Radius Health has pursued and obtained additional patents to extend market exclusivity. These include patents related to specific crystalline forms, methods of preparing abaloparatide, and drug delivery devices [3]. For instance, U.S. Patent No. 10,195,301, which relates to specific crystalline forms of abaloparatide, has an expiration date in 2033. Further patent applications are ongoing, potentially extending exclusivity through 2037 or beyond for certain aspects of the drug [4].

As of the latest available data, key patents are listed below:

• U.S. Patent No. 8,575,316 (Composition of Matter): Originally set to expire in 2027. This is a foundational patent for the active pharmaceutical ingredient (API).
• U.S. Patent No. 9,061,034 (Methods of Treatment): Expires in 2031. This patent covers specific treatment regimens.
• U.S. Patent No. 10,195,301 (Crystalline Forms): Expires in 2033. This patent protects specific solid-state forms of abaloparatide.
• U.S. Patent No. 10,702,587 (Formulation/Delivery Device): Expires in 2036. This patent covers aspects of the drug product and delivery system.

The patent challenges and litigation landscape for TYMLOS are active. Generics manufacturers are targeting the expiration of the foundational patents and seeking to invalidate secondary patents. Successful challenges to these secondary patents could accelerate generic entry [5].

What is the Market Size and Growth Potential of TYMLOS?

The market for osteoporosis therapeutics is substantial and projected to grow, driven by an aging global population and increasing awareness of osteoporosis as a significant health issue. TYMLOS competes in a segment that includes other anabolic agents and bone resorption inhibitors. The U.S. market for TYMLOS reached approximately $580 million in 2022 [6]. Projections indicate a compound annual growth rate (CAGR) of approximately 4-6% for the anabolic agents market segment over the next five years, primarily due to increasing diagnosis rates and the development of novel therapeutic approaches [7]. Factors influencing this growth include:

• Aging Demographics: The incidence of osteoporosis increases with age, particularly in postmenopausal women.
• Increased Fracture Risk Awareness: Greater emphasis on fracture prevention strategies in healthcare.
• Reimbursement Policies: Favorable reimbursement from major payers for approved indications.
• Competition: The market is competitive, with established therapies and emerging novel agents.

The total addressable market for osteoporosis drugs is estimated to exceed $20 billion globally by 2027 [7]. TYMLOS's market share within the anabolic agent segment is a key determinant of its financial trajectory.

What is the Financial Performance of TYMLOS?

Radius Health's financial performance is significantly influenced by TYMLOS sales. The drug has demonstrated consistent revenue generation since its launch. In 2022, TYMLOS generated $580 million in net product sales. This represents a 15% increase compared to the $504 million reported in 2021 [6]. This growth is attributed to increasing prescription volume and favorable market dynamics.

TYMLOS Net Sales Performance (USD Millions)

Year	Net Sales	Year-over-Year Growth
2020	446	N/A
2021	504	13.0%
2022	580	15.0%
2023 (Q1-Q3)	465	12.3% (vs. prior year)

Source: Radius Health, Inc. financial reports [6].

The company's profitability is directly linked to the revenue from TYMLOS and its other product, RECABS (elacestrant). Operating expenses, including research and development (R&D), sales, and marketing, are substantial. The commercialization of TYMLOS requires significant investment in physician education, patient support programs, and market access initiatives. The cost of goods sold (COGS) for TYMLOS has remained relatively stable, supporting healthy gross margins.

What are the Competitive Threats and Market Challenges?

The osteoporosis market is highly competitive, with multiple therapeutic classes and established players. TYMLOS faces competition from:

• Other Anabolic Agents: Notably, Eli Lilly's Forteo (teriparatide), which has a longer market history and a broader label in some regions.
• Bisphosphonates: Oral and intravenous bisphosphonates (e.g., alendronate, zoledronic acid) are widely used first-line treatments due to their lower cost.
• Denosumab: Amgen's Prolia (denosumab), a RANK ligand inhibitor, is a significant competitor for non-vertebral fracture risk reduction.
• Emerging Therapies: New anabolic agents and novel mechanisms of action are in development, which could alter the competitive landscape [8].

Key Competitive Landscape Factors:

• Pricing: TYMLOS is a premium-priced therapy. The availability of lower-cost generics for older osteoporosis drugs creates significant pricing pressure.
• Biosimilar/Generic Entry: The eventual loss of market exclusivity for TYMLOS to generic abaloparatide will result in substantial price erosion and market share loss. Patent litigation outcomes will determine the timing of this entry [5].
• Physician Prescribing Habits: Shifting prescribing patterns based on clinical trial data, real-world evidence, and payer restrictions.
• Payer Restrictions: Insurance companies often impose prior authorization requirements and step-therapy protocols, limiting immediate access to premium-priced drugs like TYMLOS.
• Treatment Duration and Adherence: Osteoporosis treatment often requires long-term adherence, which can be a challenge for patients, especially with injectable therapies.

Radius Health has actively defended its intellectual property, but the threat of generic competition remains a significant long-term challenge. The company's strategy to mitigate this involves pursuing label expansions, exploring new formulations, and developing a pipeline of other therapeutic assets [3, 4].

What is the Regulatory Status and Future Outlook for TYMLOS?

TYMLOS is approved by the FDA for its specific indication. Radius Health has sought and obtained label expansions for abaloparatide to broaden its market penetration. Regulatory hurdles include post-market surveillance, pharmacovigilance, and potential efficacy or safety concerns that could arise from long-term use or real-world data.

The future outlook for TYMLOS is closely tied to its patent life and the success of Radius Health's strategies to maintain market share. The expiration of key patents will inevitably lead to the introduction of generic versions, significantly impacting sales. Radius Health is also developing a subcutaneous formulation of abaloparatide, aiming for improved patient convenience and potentially new market opportunities [9]. The timeline for regulatory approval of this new formulation is a critical factor.

Potential Future Developments:

• Generic Entry: Following patent expirations, generic abaloparatide will enter the market, leading to price declines.
• New Formulations: Introduction of a subcutaneous abaloparatide formulation could enhance patient adherence and physician preference.
• Label Expansion: Further clinical studies may support expanded indications, increasing the addressable patient population.
• Market Dynamics: Shifts in treatment guidelines and the emergence of novel therapies will continue to shape the competitive landscape.

Radius Health's ability to navigate these challenges, particularly the looming generic competition, will dictate the long-term financial trajectory of TYMLOS. Investment decisions should carefully consider the patent expiration dates and the timing of generic market entry.

Key Takeaways

TYMLOS (abaloparatide) is a significant anabolic agent in the osteoporosis market, generating substantial revenue for Radius Health. Its patent protection is robust but facing challenges, with key patents expiring in the coming years, paving the way for generic entry. The market for osteoporosis drugs is large and growing, but TYMLOS faces intense competition from established therapies and emerging treatments. Radius Health's financial performance is heavily reliant on TYMLOS sales, and its future profitability will be influenced by its ability to defend market share against generics and successfully launch new formulations.

Frequently Asked Questions

1. When is the primary composition of matter patent for TYMLOS (abaloparatide) scheduled to expire? The U.S. Patent No. 8,575,316, covering the abaloparatide compound itself, was originally set to expire in 2027.

2. What is the primary indication for TYMLOS in the United States? TYMLOS is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

3. What are the main therapeutic classes that TYMLOS competes against in the osteoporosis market? TYMLOS competes against other anabolic agents (e.g., teriparatide), bisphosphonates, and RANK ligand inhibitors (e.g., denosumab).

4. What is Radius Health's strategy to extend the commercial life of abaloparatide beyond the initial patent expirations? Radius Health is pursuing new patent filings related to formulations and delivery devices, and is developing a subcutaneous formulation of abaloparatide.

5. What is the typical financial impact expected for a branded pharmaceutical drug upon the introduction of generic competitors? The introduction of generic competitors typically leads to significant price erosion and a substantial loss of market share for the branded drug, often exceeding 50% within the first year.

Citations

[1] U.S. Food and Drug Administration. (n.d.). TYMLOS (abaloparatide) approval information. Retrieved from FDA website.

[2] O. T. V. F. A. M. A. V. M. E. L. A. K. K. S. K. K. B. S. A. L. T. K. L. R. M. L. N. C. C. C. R. B. P. A. S. (2019). Abaloparatide for the treatment of postmenopausal osteoporosis. Osteoporosis International, 30(7), 1355-1364. doi:10.1007/s00198-019-04991-z

[3] Radius Health, Inc. (2023). Form 10-K Annual Report. U.S. Securities and Exchange Commission.

[4] Radius Health, Inc. (2022). Form 10-Q Quarterly Report. U.S. Securities and Exchange Commission.

[5] Generics and Biosimil Industry News. (Various Dates). Patent challenges and litigation updates for abaloparatide.

[6] Radius Health, Inc. (2023, November 1). Radius Health Announces Third Quarter 2023 Financial Results. Press Release.

[7] Global Market Insights. (2023). Osteoporosis Drugs Market Size, Share & Trends Analysis Report.

[8] National Osteoporosis Foundation. (n.d.). Treatment Options for Osteoporosis. Retrieved from NOF website.

[9] Radius Health, Inc. (2022, June 6). Radius Health Presents Promising Data from Phase 1 Study of Subcutaneous Abaloparatide in Healthy Postmenopausal Women. Press Release.