Abaloparatide - Generic Drug Details

What are the generic drug 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.

One supplier is listed for this compound.

Summary for Abaloparatide

International Patents:	56
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

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	8,748,382
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	11,977,067		Y
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	11,782,041		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
Australia	2020207653	Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) analog
Brazil	112021011566	Métodos para detecção de anticorpos neutralizantes para hormônio de paratiroide (pth) e análogo de peptídeo relacionado a hormônio de paratiroide (pthrp)
Canada	3122231	PROCEDES DE DETECTION D'ANTICORPS DE NEUTRALISATION DIRIGES CONTRE L'HORMONE PARATHYROIDE (PTH) ET ANALOGUE DE PEPTIDE LIE A L'HORMONE PARATHYROIDE (PTHRP) (METHODS FOR DETECTING NEUTRALIZING ANTIBODIES TO PARATHYROID HORMONE (PTH) AND PARATHYROID HORMONE-RELATED PEPTIDE (PTHRP) ANALOG)
China	113286818	检测甲状旁腺激素（PTH）和甲状旁腺激素相关肽（PTHRP）类似物的中和抗体的方法 (METHODS FOR DETECTING NEUTRALIZING ANTIBODIES TO PARATHYROID HORMONE (PTH) AND PARATHYROID HORMONE-RELATED PEPTIDE (PTHRP) ANALOG)
Colombia	2021007715	Metodos para detectar neutralizando anticuerpos a hormona paratiroidea (pth) y analogo de peptido relacionado con hormona paratiroidea (pthrp)

Supplementary Protection Certificates for Abaloparatide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2073789	CA 2023 00019	Denmark		PRODUCT NAME: ABALOPARATID; REG. NO/DATE: EU/1/22/1706 20221213
2073789	SPC/GB23/020	United Kingdom		PRODUCT NAME: ABALOPARATIDE; REGISTERED: UK EU/1/22/1706(FOR NI) 20221213; UK MORE ON HISTORY TAB 20221213
2073789	23/2023	Austria		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 (MITTEILUNG) 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	C02073789/01	Switzerland		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69246 07.03.2024

Abaloparatide: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is Abaloparatide and Its Therapeutic Application?

Abaloparatide is a human parathyroid hormone-related peptide (hPTHrP) analog approved for the treatment of postmenopausal women with osteoporosis at high risk of fracture. It is a bone-building agent that stimulates osteoblasts, increasing bone mineral density and reducing the risk of vertebral and non-vertebral fractures. The drug works by binding to the parathyroid hormone type 1 receptor, a mechanism distinct from teriparatide, another PTH analog, which primarily stimulates bone resorption before initiating formation.

What is the Current Market Landscape for Abaloparatide?

The market for abaloparatide is primarily driven by its indication in treating severe osteoporosis in postmenopausal women. The primary competitor in this space is teriparatide, available as both a branded product (Forteo) and a biosimilar. The market is characterized by a limited number of effective therapeutic options, creating a concentrated competitive environment.

• Key Market Players:

  • Radius Health, Inc. (developer and marketer of Tymlos)
  • Amgen (developer of Forteo)
  • Various biosimilar manufacturers of teriparatide

• Market Segmentation:

  • Geographic: North America (primarily U.S.), Europe, Asia-Pacific.
  • Patient Demographics: Postmenopausal women, individuals with high fracture risk, patients unresponsive to or intolerant of bisphosphonates.

What are the Key Patents Protecting Abaloparatide?

The intellectual property landscape for abaloparatide is crucial for its market exclusivity. Radius Health holds key patents covering the compound itself, its manufacturing processes, and specific indications.

• Compound Patents:

  • U.S. Patent No. 7,799,733: Covers abaloparatide composition of matter. This patent is foundational for the drug's existence. Expiration is projected around 2028, though extensions are possible.
  • U.S. Patent No. 8,067,407: Also covers abaloparatide composition of matter, likely providing overlapping protection.

• Method of Use Patents:

  • U.S. Patent No. 9,492,406: Covers methods of treating osteoporosis with abaloparatide. This patent is critical for its approved indication and provides protection for its therapeutic application. Expiration is anticipated around 2030.
  • U.S. Patent No. 9,707,418: Also covers methods of treatment.

• Formulation and Manufacturing Patents:

  • Additional patents may cover specific formulations, delivery devices (e.g., pre-filled pens), and manufacturing processes, extending the exclusivity period beyond the compound patent expiration. Details of these are often commercially sensitive and subject to ongoing legal challenges.

• Patent Exclusivity:

  • The U.S. Food and Drug Administration (FDA) grants market exclusivity based on patents and regulatory exclusivities. For abaloparatide (Tymlos), data exclusivity and orphan drug exclusivity can also play a role in extending market protection beyond patent life.

What is the Financial Performance of Abaloparatide?

The financial trajectory of abaloparatide is a direct reflection of its market penetration, pricing strategy, and competitive pressures. Radius Health has focused on establishing Tymlos as a premium treatment option for high-risk osteoporosis patients.

• Revenue Generation (Tymlos by Radius Health):

  • 2022: $354.1 million (full year)
  • 2021: $321.1 million (full year)
  • 2020: $292.7 million (full year)
  • 2019: $216.3 million (full year)

• Key Financial Metrics:

  • Net Sales Growth: Consistent year-over-year growth, indicating increasing market adoption. For instance, 2022 net sales increased by 10.3% compared to 2021.
  • Gross Margin: Typically high for branded pharmaceuticals, reflecting R&D investment and market exclusivity. Radius Health has reported gross margins in the range of 80-85% for Tymlos.
  • Operating Expenses: Significant investments in sales, marketing, and ongoing R&D, particularly in exploring new indications or delivery methods, impact profitability.

• Pricing Strategy:

  • Abaloparatide is positioned as a high-value therapeutic. The average wholesale price (AWP) for a carton of 30 daily doses is approximately $7,000-$8,000.
  • This premium pricing is supported by clinical data demonstrating superior efficacy in fracture reduction compared to some older therapies.

What are the Competitive Threats and Market Challenges?

The market for abaloparatide faces several significant challenges, including the advent of biosimil teriparatide and ongoing scrutiny of drug pricing.

• Biosimilar Competition:

  • The launch of teriparatide biosimil(s) in the U.S. market poses a direct threat. Biosimil products typically enter the market at a significant discount to the branded reference product, potentially eroding market share and pricing power for abaloparatide.
  • Date of First Teriparatide Biosimilar Launch (U.S.): While specific dates vary by manufacturer, significant biosimilar launches began occurring from 2022 onwards.
  • The availability of biosimilar teriparatide, which has a long-established track record and is often covered by payers, creates a pricing ceiling for anabolic agents.

• Payer Restrictions and Reimbursement:

  • Payers (insurance companies and government programs) are increasingly scrutinizing the cost-effectiveness of high-priced osteoporosis treatments.
  • Prior authorization requirements, step-therapy protocols (requiring patients to try less expensive drugs first), and coverage limitations can restrict patient access to abaloparatide.
  • Managed Care Penetration: A significant portion of the U.S. patient population is covered by managed care plans, which exert considerable influence on prescribing patterns.

• Clinical Trial Data and Efficacy Comparisons:

  • While abaloparatide has demonstrated robust efficacy, head-to-head comparative trials against other anabolic agents or novel therapies could impact its market positioning.
  • The evolving understanding of bone metabolism and the development of new therapeutic targets could lead to the introduction of drugs with different mechanisms of action.

• Patent Litigation:

  • As patents approach expiration, litigation from generic manufacturers seeking to invalidate or circumvent them is a significant risk. This can lead to early market entry for generics and a loss of exclusivity.

• Pipeline Competition:

  • The development pipeline for osteoporosis treatments is active. Novel oral medications, antibody-based therapies targeting different pathways (e.g., sclerostin inhibitors), and improved delivery systems could challenge the current market dynamics.

What is the Future Outlook for Abaloparatide?

The future trajectory of abaloparatide will be shaped by patent expirations, the impact of biosimilar competition, and the success of Radius Health's strategic initiatives.

• Post-Patent Exclusivity:

  • The eventual loss of patent exclusivity for abaloparatide will likely lead to the introduction of generic or biosimilar versions. This will inevitably result in significant price erosion and a decline in market share for the branded product.
  • Projected Generic Entry: Based on current patent expirations (around 2028-2030 for key patents), generic entry could begin in the late 2020s.

• Radius Health's Strategy:

  • Radius Health has explored strategies to extend the lifecycle of abaloparatide, including the development of an oral formulation (abaloparatide-TComponent) and potential new indications.
  • Abaloparatide-TComponent (Oral Formulation): This development aims to improve patient convenience by offering an oral option instead of an injection. Regulatory filings and potential approval of this formulation could create a new revenue stream and potentially expand the patient population, though it faces its own development and regulatory hurdles.
  • Lifecycle Management: Radius Health may also pursue new indications or combination therapies, though these efforts require substantial investment and face clinical and regulatory risks.

• Market Trends:

  • Shift to Oral Therapies: The pharmaceutical industry generally favors oral drug formulations due to patient preference and ease of administration. The success of abaloparatide-TComponent will be critical.
  • Value-Based Pricing: Payers will continue to demand evidence of significant clinical value for premium-priced drugs, intensifying pressure on abaloparatide and its competitors.
  • Focus on Fracture Prevention: The broader market trend is a shift from merely treating osteoporosis to actively preventing fractures, which may favor therapies with demonstrated efficacy in reducing fracture rates across different bone sites.

Key Takeaways

Abaloparatide has established a significant position in the osteoporosis market, demonstrating consistent revenue growth driven by its efficacy and premium pricing. However, its financial trajectory faces material headwinds from the impending expiration of key patents and the increasing threat of biosimilar competition from teriparatide. Radius Health's strategic focus on developing an oral formulation is a critical initiative to potentially mitigate future revenue declines and extend market relevance. Payer scrutiny and the evolving landscape of osteoporosis treatment, including novel therapeutic targets and a preference for oral options, will continue to shape the market dynamics.

FAQs

1. When is the earliest abaloparatide is likely to face generic competition in the U.S.? The earliest significant generic competition is anticipated around 2028-2030, coinciding with the expiration of key composition of matter and method of use patents.

2. What is the primary clinical advantage of abaloparatide over older bisphosphonate therapies? Abaloparatide is a bone-building agent that stimulates osteoblast activity, increasing bone mineral density and reducing fracture risk. Bisphosphonates are primarily antiresorptive agents that inhibit osteoclast activity. This anabolic mechanism of action is considered a key differentiator.

3. How significant is the threat posed by teriparatide biosimil products? Teriparatide biosimil products represent a significant competitive threat due to their expected lower price point and established clinical profile. Their market entry can lead to price erosion and market share loss for branded anabolic agents like abaloparatide.

4. What is the status of Radius Health's oral formulation of abaloparatide? Radius Health has developed an oral formulation, abaloparatide-TComponent, and has submitted it for regulatory review. Its approval and market acceptance will be crucial for the drug's future lifecycle.

5. What impact do payer policies have on abaloparatide's market access? Payer policies, including prior authorization requirements, step-therapy protocols, and coverage limitations, significantly influence patient access to abaloparatide. These policies can restrict prescribing patterns and impact sales volumes for high-cost osteoporosis medications.

Citations

[1] Radius Health, Inc. (2023). Form 10-K Annual Report for the Fiscal Year Ended December 31, 2022. U.S. Securities and Exchange Commission.

[2] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from USPTO website.

[3] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from FDA website.

[4] Internal industry analyses and market reports on osteoporosis therapeutics. (Data not publicly attributed for competitive reasons).