Abaloparatide - Generic Drug Details

What are the generic sources for abaloparatide and what is the scope of patent protection?

Abaloparatide is the generic ingredient in one branded drug marketed by Radius and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abaloparatide has fifty-five patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for abaloparatide

International Patents:	55
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	16
Patent Applications:	436
Drug Prices:	Drug price trends for abaloparatide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for abaloparatide
What excipients (inactive ingredients) are in abaloparatide?	abaloparatide excipients list
DailyMed Link:	abaloparatide at DailyMed

See drug prices for abaloparatide

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

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

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 abaloparatide

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

Sponsor	Phase
Qilu Pharmaceutical Co., Ltd.	PHASE3
Marmara University	PHASE4
Daniel Horwitz	Phase 4

See all abaloparatide clinical trials

Pharmacology for abaloparatide

Drug Class

Parathyroid Hormone-Related Peptide Analog

Anatomical Therapeutic Chemical (ATC) Classes for abaloparatide

H05AA	Parathyroid hormones and analogues
H05A	PARATHYROID HORMONES AND ANALOGUES
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for ABALOPARATIDE

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 abaloparatide

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			Y
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
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes

EU/EMA Drug Approvals for abaloparatide

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 abaloparatide

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

Supplementary Protection Certificates for abaloparatide

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

Market Dynamics and Financial Trajectory for Abaloparatide

Last updated: July 27, 2025

Introduction

Abaloparatide, marketed as Tymlos, is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP). Approved by the U.S. Food and Drug Administration (FDA) in 2017, it addresses postmenopausal osteoporosis predominantly in high-risk women. As a novel therapeutic option, abaloparatide's market trajectory hinges on evolving clinical evidence, regulatory pathways, healthcare provider adoption, and competitive landscape. This analysis delineates the prevailing market dynamics and financial prospects for abaloparatide within the broader osteoporosis treatment market.

Market Overview

Osteoporosis and its Growing Burden

Osteoporosis affects over 200 million individuals globally, predominantly impacting women over 50. The condition considerably elevates fracture risk, leading to increased morbidity, mortality, and healthcare costs. The global osteoporosis therapeutics market was valued at approximately USD 10 billion in 2021, with projections approaching USD 16 billion by 2027([1]). This growth trajectory underscores substantial commercial opportunities for innovative drugs like abaloparatide.

Current Therapeutic Landscape

The osteoporotic treatment paradigm comprises antiresorptive agents—bisphosphonates (e.g., alendronate), selective estrogen receptor modulators (SERMs), and denosumab—and anabolic therapies such as teriparatide and abaloparatide. The latter class promotes bone formation, critical for high-risk populations. Notably, abaloparatide’s approval positioned it as a key competitor to existing anabolic agents, particularly teriparatide.

Market Dynamics Influencing Abaloparatide

1. Clinical Efficacy and Safety Profile

Abaloparatide demonstrates superior efficacy in increasing bone mineral density (BMD) and reducing vertebral and non-vertebral fracture risk compared to placebo and, in some cases, teriparatide([2]). Its safety profile is well-characterized; the most notable side effects include dizziness and hypercalcemia, with a low incidence of osteosarcoma observed in preclinical studies. Continuous accumulation of real-world evidence is expected to bolster its market acceptance.

2. Regulatory Environment and Approvals

Beyond the FDA approval in 2017, regulatory agencies such as the European Medicines Agency (EMA) have reviewed abaloparatide, though approval timelines have varied due to differing evidentiary requirements. Pending or regional approvals can significantly influence market penetration, especially in Europe and Asia.

3. Reimbursement and Pricing Strategies

Pricing strategies for abaloparatide are aligned with other anabolic therapies, with list prices ranging around USD 4,000–5,000 per month ([3]). Reimbursement policies and formulary placements greatly impact accessibility. Better coverage, especially via Medicare and private payers, can accelerate adoption among high-risk patients.

4. Competitive Landscape

The primary competitors include teriparatide (Forteo) and romosozumab (Evenity). While teriparatide remains the gold standard, abaloparatide's differentiated mechanism of action and potentially improved tolerability position it favorably. The emergence of biosimilars and next-generation anabolic agents might pose future competitive threats.

5. Market Adoption and Physician Perception

Physician familiarity and confidence in abaloparatide influence prescription trends. Education about its benefits over existing therapies, coupled with clinical guideline endorsements, serve as catalysts for broader utilization.

6. Healthcare System Dynamics and Patient Preferences

Growing emphasis on personalized medicine and patient adherence influences market dynamics. Abaloparatide’s subcutaneous administration may be less preferred compared to oral agents, yet its superior efficacy for high-risk patients sustains its niche.

Financial Trajectory and Revenue Projections

Market Penetration Projections

Analysts project abaloparatide to capture approximately 10–15% of the anabolic osteoporosis market by 2025, translating to USD 1–2 billion in annual sales globally([4]). The adoption rate depends on regional approvals, insurance coverage, and clinician preference.

Revenue Drivers

• High-risk patient populations: Focused usage among women with prior fractures or high fracture risk.
• Extension into other markets: Regulatory expansion into Europe, Asia, and emerging economies.
• Combination therapies: Potential for synergistic regimens, enhancing utility and revenue.

Pricing and Reimbursement Impact

Stability or incremental increases in pricing, coupled with improved reimbursement frameworks, will directly influence revenue streams. Enhanced market access programs are crucial for expanding patient reach.

Competitive Risks and Market Challenges

Emerging therapies, reduction in treatment duration, or biosimilars could pressure pricing and market share. Additionally, safety concerns or new clinical data could shift prescribing behaviors.

Strategic Outlook

Pharmaceutical companies with marketed abaloparatide are likely to prioritize clinical and health economic evidence generation to secure broader formulary inclusion. Collaborations for combination therapies and expansion into preventive or early-intervention segments could diversify revenue channels. Long-term growth hinges on addressing unmet needs, particularly in men and broader patient subsets.

Key Takeaways

• Growing Osteoporosis Burden: Increasing prevalence and healthcare costs underpin sustained demand for effective therapies like abaloparatide.
• Competitive Edge: Its efficacy profile offers competitive advantages over existing anabolic agents, fostering rapid adoption in suitable patient populations.
• Regulatory and Reimbursement Strategies: Expanding approvals and favorable reimbursement policies are pivotal to unlocking commercial potential.
• Market Penetration Prospects: With strategic positioning and clinician education, abaloparatide could secure a significant share of the anabolic segment, potentially reaching USD 1–2 billion in annual revenue by 2025.
• Future Opportunities: Innovations in combination therapy, extending into male osteoporosis, and emerging markets present promising growth avenues.

FAQs

1. How does abaloparatide differ from teriparatide in treating osteoporosis?
Abaloparatide is a selective PTHrP analog with a potentially favorable safety profile and pharmacodynamic profile, leading to comparable or superior increases in bone density and fracture risk reduction. Its receptor binding affinity and activation differ, possibly resulting in less hypercalcemia and fewer side effects.

2. What are the key factors influencing abaloparatide's market adoption?
Major factors include clinical efficacy, safety profile, regulatory approvals across regions, reimbursement policies, clinician familiarity, and competitive positioning against existing therapies.

3. Are biosimilars or generics impacting the abaloparatide market?
Currently, abaloparatide is a branded biologic, with no biosimilars on the market, although biosimilar development could influence future pricing and market share.

4. How significant is regional approval in shaping abaloparatide's global market?
Regional approvals dictate market access; delayed or restricted approvals limit geographic expansion. European and Asian markets represent substantial growth opportunities upon gaining regulatory clearance.

5. What future development strategies could enhance abaloparatide’s market trajectory?
Strategies include expanding indications, developing combination therapies, improving patient adherence through delivery innovations, and advocating for guideline endorsements and reimbursement reforms.

References

[1] Grand View Research. Osteoporosis Therapeutics Market Size, Share & Trends Analysis Report, 2021–2027.

[2] Miller PD, et al. Efficacy and Safety of Abaloparatide in Postmenopausal Women with Osteoporosis. NEJM. 2016.

[3] MarketWatch. Abaloparatide Pricing and Reimbursement Dynamics. 2022.

[4] EvaluatePharma. Osteoporosis Market Forecast 2023–2028.