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-three patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for ABALOPARATIDE

International Patents:	53
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	14
Patent Applications:	128
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
Daniel Horwitz	Phase 4
Johns Hopkins University	Phase 2
David Lunardini	Phase 2

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
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

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/004157 Treatment of osteoporosis.	Refused	no	no	no		2019-01-07
Theramex Ireland Limited	Eladynos	abaloparatide	EMEA/H/C/005928 Treatment 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
World Intellectual Property Organization (WIPO)	2020144653
Portugal	2073789
Mexico	2009003569	METODO DE ADMINISTRACION DE FARMACOS PARA LA PROTEINA ANABOLICA OSEA. (METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN.)
New Zealand	576682	METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN PARATHYROID HORMONE-RELATED PROTEIN (PTHrP)
Singapore	11202106223R	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)
Mexico	2021007056	MÉTODOS PARA DETECTAR ANTICUERPOS NEUTRALIZADORES DE HORMONA PARATIROIDEA (PTH) Y ANÁLOGO DE PÉPTIDO RELACIONADO CON HORMONA PARATIROIDEA (PTHRP). (METHODS FOR DETECTING NEUTRALIZING ANTIBODIES TO PARATHYROID HORMONE (PTH) AND PARATHYROID HORMONE-RELATED PEPTIDE (PTHRP) ANALOG.)

Supplementary Protection Certificates for ABALOPARATIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2073789	LUC00309	Luxembourg		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
2073789	2023C/523	Belgium		PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213
2073789	122023000031	Germany		PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 20221212
2073789	CA 2023 00019	Denmark		PRODUCT NAME: ABALOPARATID; REG. NO/DATE: EU/1/22/1706 20221213

ABALOPARATIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abaloparatide

Introduction

Abaloparatide, a novel bone anabolic agent, has been making significant waves in the treatment of postmenopausal osteoporosis. Approved by the U.S. Food and Drug Administration (FDA) in 2017 under the trade name Tymlos®, this drug has shown promising results in reducing the risk of fractures and improving bone mineral density. Here, we delve into the market dynamics and financial trajectory of abaloparatide.

Market Size and Growth

The global market for abaloparatide injections is projected to experience substantial growth. As of 2023, the market size was valued at approximately USD 1.5 billion and is expected to reach around USD 3.8 billion by 2032[1].

Competitive Landscape

Abaloparatide competes in a market dominated by other osteoporosis treatments, notably teriparatide. However, studies have shown that abaloparatide offers several advantages, including a higher reduction in the incidence of new vertebral and nonvertebral fractures compared to teriparatide and placebo[5].

Cost-Effectiveness Analysis

A cost-effectiveness analysis revealed that abaloparatide is a dominant treatment strategy over teriparatide. The analysis showed that abaloparatide accrued higher quality-adjusted life-years (QALYs) at lower costs, making it a cost-effective option for treating postmenopausal women at high risk of fracture[2].

Regional Market Penetration

Teijin Pharma's launch of abaloparatide acetate under the tradename OSTABALO® in Japan marks a significant milestone in regional market penetration. Japan, with an estimated 13 million patients suffering from osteoporosis, presents a substantial market opportunity. The drug is priced at JPY 16,128 for a 1.5mg subcutaneous injection cartridge, positioning it as a strategic product for robust market penetration[3].

Clinical Efficacy

Clinical trials, such as the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial, have demonstrated the efficacy of abaloparatide. The drug significantly reduces the incidence of new vertebral and nonvertebral fractures and improves bone mineral density at the total hip, femoral neck, and lumbar spine compared to placebo and teriparatide[5].

Safety Profile

Abaloparatide has a favorable safety profile, with a lower incidence of hypercalcemia compared to teriparatide. This makes it a preferable option for patients who are at risk of hypercalcemia-related complications[5].

Market Drivers

Several factors are driving the growth of the abaloparatide market:

• Increasing Prevalence of Osteoporosis: The rising number of postmenopausal women with osteoporosis, particularly those at high risk of fractures, is a significant driver.
• Clinical Efficacy: The drug's proven ability to reduce fracture risk and improve bone mineral density.
• Cost-Effectiveness: Abaloparatide's favorable cost-effectiveness profile compared to other treatments.
• Regional Expansion: Entry into new markets, such as Japan, is expanding the drug's reach[1][3][5].

Market Restraints

Despite the positive outlook, there are some restraints to consider:

• High Development Costs: The cost of developing and bringing new drugs to market can be prohibitive.
• Regulatory Hurdles: Navigating regulatory approvals in different regions can be challenging.
• Competition: The presence of established treatments like teriparatide and other osteoporosis medications[2][3].

Financial Projections

The financial trajectory for abaloparatide is promising, with the global market expected to more than double by 2032. Here are some key financial projections:

• Market Size: Expected to grow from USD 1.5 billion in 2023 to USD 3.8 billion by 2032[1].
• API Market: The global abaloparatide API market is projected to grow from USD 350 million in 2023 to USD 1.2 billion by 2032, reflecting a compound annual growth rate (CAGR) driven by increasing demand for the active ingredient[4].

Key Players

The market for abaloparatide is dominated by a few key players:

• Radius Health, Inc.: The original developer and marketer of abaloparatide under the trade name Tymlos® in the U.S.
• Teijin Pharma: Partnering with Radius Health for the development and sales of abaloparatide in Japan under the tradename OSTABALO®[3].

Conclusion

Abaloparatide is poised to become a leading treatment for postmenopausal osteoporosis, driven by its clinical efficacy, cost-effectiveness, and expanding market reach. As the global market continues to grow, it is clear that abaloparatide will play a significant role in the treatment landscape for osteoporosis.

Key Takeaways

• Market Growth: The global abaloparatide market is expected to reach USD 3.8 billion by 2032.
• Clinical Efficacy: Abaloparatide significantly reduces the risk of new vertebral and nonvertebral fractures.
• Cost-Effectiveness: Abaloparatide is a cost-effective treatment option compared to teriparatide.
• Regional Expansion: Entry into new markets, such as Japan, is expanding the drug's reach.
• Financial Projections: The global abaloparatide API market is projected to grow to USD 1.2 billion by 2032.

FAQs

Q: What is the current market size of abaloparatide injections? A: The global market size for abaloparatide injections was valued at approximately USD 1.5 billion in 2023[1].

Q: How does abaloparatide compare to teriparatide in terms of cost-effectiveness? A: Abaloparatide is more cost-effective than teriparatide, offering higher QALYs at lower costs[2].

Q: Which company is responsible for the launch of abaloparatide in Japan? A: Teijin Pharma is responsible for the launch of abaloparatide under the tradename OSTABALO® in Japan[3].

Q: What are the primary benefits of using abaloparatide for osteoporosis treatment? A: Abaloparatide significantly reduces the risk of new vertebral and nonvertebral fractures and improves bone mineral density[5].

Q: What is the projected growth rate for the global abaloparatide API market? A: The global abaloparatide API market is projected to grow from USD 350 million in 2023 to USD 1.2 billion by 2032[4].

Sources

1. Dataintelo: Abaloparatide Injection Market Research Report 2032.
2. PubMed: Cost-effectiveness Analysis of Sequential Treatment of Postmenopausal Osteoporosis.
3. Teijin Pharma: Teijin Pharma to Launch Japan-market Sales of Abaloparatide Acetate for Osteoporosis.
4. Dataintelo: Abaloparatide API Market Research Report 2032.
5. JAMA Network: Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women with Osteoporosis.