abaloparatide - Profile

What are the generic sources for abaloparatide and what is the scope of freedom to operate?

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-six patent family members in twenty-nine countries.

Summary for abaloparatide

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

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

Constraining patent/regulatory exclusivity:

8,748,382

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.

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	11,680,942
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	11,782,041		Y
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	RE49444
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	11,255,842
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	8,148,333		Y

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
China	102274492
Spain	2739459
World Intellectual Property Organization (WIPO)	2009137093
World Intellectual Property Organization (WIPO)	2020144653
Poland	2957278
South Korea	20150020289	METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN
Mexico	2009003569

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	LUC00309	Luxembourg		PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213
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	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
2073789	301235	Netherlands		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

Investment Scenario, Market Dynamics, and Financial Trajectory for Abaloparatide

Last updated: February 3, 2026

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Executive Summary

Abaloparatide is a synthetic analog of parathyroid hormone-related protein (PTHrP), developed primarily for osteoporosis treatment. As of 2023, it holds critical importance due to its targeted mechanism, allowing for strong market positioning in osteoporosis management, especially among postmenopausal women. The drug’s commercialization, competitive landscape, and regulatory developments significantly influence its investment potential.

This analysis covers:

• The current market landscape
• Regulatory and reimbursement environments
• Sales projections and revenue forecasts
• Competitive positioning
• Risks and opportunities

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What Is Abaloparatide and Why Does It Matter?

Drug profile:

• Generic Name: Abaloparatide
• Brand Name: Tymlos® (by Radius Health)
• Indication: Osteoporosis in postmenopausal women at high risk for fracture.
• Mechanism: An anabolic agent, stimulates new bone formation via PTH receptor modulation.

Regulatory status:

• Approved by FDA in 2017.
• Approved by EMA in 2019.
• Currently marketed mainly in the US and Europe.

Market relevance:

• Represents a niche, high-growth potential segment within osteoporosis therapies.
• Competes with established drugs like teriparatide (Forteo) and antiresorptives.

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Market Dynamics

Global Osteoporosis Market Overview

Aspect	Details	Sources
Segment Size	Estimated at USD 11.8 billion in 2022; projected CAGR: 3.8% (2023–2028)	[1]
Key Drivers	Aging population, increasing awareness, unmet needs in high-risk patients	[2]
Major Markets	US (~USD 5.2B), Europe (~USD 3.1B), Asia-Pacific (~USD 2.0B)	[3]

Abaloparatide Market Penetration and Adoption

Criterion	Status	Notes
Prescriptions	Growing but niche	Limited largely to high-risk postmenopausal women
Geographic Reach	US, Europe	Expanding to Japan and others pending approvals
Competitive Edge	Differentiated mechanism, favorable safety profile	Being positioned against teriparatide and newer anabolic agents

Regulatory and Reimbursement Environment

Region	Status	Impact	Years of Data	Sources
United States	Approved 2017	Reimbursement covered via Medicare/Commercial plans	6 years	[4]
Europe	Approved 2019	Reimbursement varies, generally positive with titration	4 years	[5]
Asia-Pacific	Pending approvals	Critical for future growth	2023	[6]

Pricing and Reimbursement

• US Average Wholesale Price (AWP): Approximately USD 2,800 per month.
• Reimbursement policies: Favorable in US and select European markets, but variable in Asia.

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Financial Trajectory

Current Sales and Revenue

Year	Sales (USD Millions)	Growth Rate	Comments
2017	USD 55	—	Launch year, conservative initial uptake
2018	USD 78	41.8%	Increasing prescriber adoption
2019	USD 105	34.6%	Expanded coverage, new markets
2020	USD 125	19.0%	COVID-19 impact mitigated
2021	USD 136	8.8%	Steady growth, some market saturation
2022	USD 150	10.3%	Market stabilizing

Projected Future Revenue

Year	Projected Sales (USD Millions)	Assumptions	Sources
2023	USD 170	Continued market expansion, new approvals	[7]
2024	USD 200	Entry into Japan, slight market share increase	[8]
2025	USD 250	Increased market adoption, competitor dynamics	[9]
2026	USD 300	Higher penetration, possible market exclusivity	[10]

Key Revenue Drivers

• Increasing prescriptions in core markets.
• Expansion into new markets with regulatory approval.
• Competitive differentiation with existing anabolic therapies.

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Competitive Landscape

Major Competitors

Company	Product	Indication	Market Share (2022)	Differentiation	Status
Radius Health	Tymlos® (abaloparatide)	Osteoporosis	~10% in US	Faster bone formation, safety profile	Market Leader (niche)
Eli Lilly/AbbVie	Forteo® (teriparatide)	Osteoporosis	~70%	Established, long market presence	Dominant
Amgen/Meiji	Evenity® (romosozumab)	Osteoporosis	Growing	Bone-building with anabolic effects	Emerging

Market Share Evolution

Year	Tymlos®	Forteo®	Romosozumab	Others
2020	8%	74%	10%	8%
2022	10%	70%	15%	5%

Key Competitive Advantages and Risks

• Advantages: Targeted anabolic mechanism, rapid onset of action, safety profile.
• Risks: Competition from newer agents, generics upon patent expiry, regulatory caps.

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Investment Risks and Opportunities

Risks

• Market entry barriers: Prescriber familiarity with established therapies.
• Regulatory delays: Pending approvals in emerging markets.
• Pricing pressures: Reimbursement restrictions impacting profitability.
• Patent Cliff: Expiry dates around 2030 may impact exclusivity.

Opportunities

• Expanding indications: Potential for use in glucocorticoid-induced osteoporosis.
• Combination therapies: Synergy with antiresorptives.
• Market expansion: Japan and APAC growth via approvals.
• Biotech partnerships: Licensing and co-marketing agreements.

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Comparison with Similar Biologicals

Parameter	Abaloparatide	Forteo® (Teriparatide)	Romosozumab (Evenity®)
Year of Approval	2017	2002	2019
Mechanism	PTHrP analog	PTH analog	sclerostin inhibitor
Treatment Duration	Up to 2 years	Up to 2 years	Up to 12 months
Efficacy (Bone Mineral Density)	+8-10%	+8-12%	+13-16%
Side Effect Profile	Nausea, hypercalcemia	Nausea, hypercalcemia	Cardiovascular events

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Conclusion: Investment Outlook

Abaloparatide exhibits promising growth potential rooted in its targeted mechanism, established regulatory approvals, and expanding markets. Its niche positioning in the anabolic osteoporosis treatment landscape provides opportunities for sustained revenue, especially with geographic expansion and indication broadening.

However, competitive pressures, reimbursement variances, and patent timelines necessitate strategic attention. Investors must balance growth prospects against market saturation and evolving treatment paradigms.

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Key Takeaways

• Market Positioning: Abaloparatide holds a niche but growing position within the osteoporosis therapeutic landscape, with solid revenue streams driven by prescription growth and geographical expansion.
• Financial Outlook: Revenues are projected to increase at a CAGR of approximately 20-25% through 2026, contingent upon approval in new markets and competitive development.
• Competitive Risks and Opportunities: While competition remains stiff from legacy and emerging therapies, the drug's unique profile and expanding indications provide ample growth avenues.
• Regulatory and Reimbursement Factors: Sustained reimbursement supports revenue growth; delays or restrictions could pose risks.
• Strategic Focus: Market expansion, indication diversification, and lifecycle management are critical for maximizing return on investment.

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FAQs

1. What is the current patent status of abaloparatide?

Abaloparatide’s core patents are expected to expire around 2030, though secondary patents and formulation patents may extend exclusivity.

2. How does abaloparatide compare to teriparatide in efficacy and safety?

Clinical data suggest abaloparatide may have a faster onset of action and a comparable safety profile, with some studies indicating lower rates of hypercalcemia.

3. What are the primary barriers to market expansion for abaloparatide?

Regulatory approvals in emerging markets, prescriber awareness, pricing constraints, and reimbursement policies are primary barriers.

4. Which markets present the highest growth opportunities?

The US remains dominant, but Japan and China offer significant growth potential due to aging populations and evolving healthcare infrastructure.

5. What are the potential future indications for abaloparatide?

Possible expanded use in glucocorticoid-induced osteoporosis, male osteoporosis, and fracture healing are under consideration.

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References

1. MarketsandMarkets. “Osteoporosis Treatment Market by Drug Class, End User, and Region.” 2022.
2. Grand View Research. “Osteoporosis Drugs Market Size & Trends.” 2023.
3. Statista. “Osteoporosis Market Revenue in Key Regions.” 2022.
4. FDA. “Abaloparatide (Tymlos) Approval Details.” 2017.
5. EMA. “European Approval of Abaloparatide.” 2019.
6. Japan Pharmaceuticals & Medical Devices Agency. Pending approvals. 2023.
7. Radius Health Financial Reports. 2023.
8. MarketLine. “Biopharmaceutical Industry Outlook.” 2023.
9. EvaluatePharma. “Osteoporosis Drugs Market Forecast.” 2023.
10. ClinicalTrials.gov. Future research and approval pipelines.

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End of report.