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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-three patent family members in twenty-eight 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 December 19, 2025. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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:	53
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Patent Applications:	38
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

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

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
Jacqueline Kernaghan	Phase 4
David Lunardini	Phase 2
Felicia Cosman, MD	Phase 4

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 and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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	11,680,942
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	11,782,041		Y

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/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 TYMLOS

See the table below for patents covering TYMLOS around the world.

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.)

Supplementary Protection Certificates for TYMLOS

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

TYMLOS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TYMLOS

Introduction

TYMLOS (abaloparatide) is a significant player in the osteoporosis treatment market, particularly among anabolic therapies. Developed by Radius Health, TYMLOS has been making waves since its launch in May 2017. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Positioning

TYMLOS is positioned as a competitive alternative to Eli Lilly's Forteo (teriparatide), another anabolic agent used for treating postmenopausal osteoporosis. TYMLOS has several advantages that have helped it gain market share:

• Price Competitiveness: TYMLOS is priced significantly lower than Forteo, with a wholesale acquisition cost (WAC) of $17,000 per year compared to Forteo's $40,000 per year. This pricing strategy has been a key factor in capturing market share[3][4].

• Efficacy: In clinical trials, TYMLOS has outperformed Forteo on several endpoints, including reduction in vertebral and non-vertebral fractures and increased bone mineral density[3].

Market Share and Growth

Since its launch, TYMLOS has demonstrated strong growth and market penetration:

• 2019 Performance: TYMLOS achieved U.S. net sales of $173.3 million for the full year 2019, a 75% increase over 2018. It captured 41% of the U.S. anabolic osteoporosis market and achieved a 50% share of new anabolic patient starts in the fourth quarter of 2019[1].

• 2021 Performance: TYMLOS net revenue continued to grow, reaching $219 million in 2021, a 5% increase from 2020. The fourth quarter of 2021 saw a record $65 million in net revenue, up 9% from the same quarter in 2020[2][5].

Financial Trajectory

The financial performance of TYMLOS reflects its growing market presence and the company's strategic management:

• Revenue Growth: TYMLOS has consistently shown revenue growth since its launch. For 2022, Radius Health projected TYMLOS net revenue to be between $232 million, with a seasonal split of approximately 42% in the first half and 58% in the second half[2][5].

• Cost Management: The company has been successful in reducing its net loss and improving adjusted EBITDA. In 2021, the net loss was reduced by 36% to $70 million, and adjusted EBITDA loss improved by 56% to $24 million compared to 2020[2][5].

• Operational Efficiency: The net revenue per commercial employee for TYMLOS increased by 47% in 2021 to $1.6 million, indicating improved productivity and efficiency in the sales force[2][5].

Pipeline and Future Developments

Radius Health is actively advancing its pipeline to further strengthen TYMLOS's market position:

• Phase 3 Studies: Recruitment for three Phase 3 studies, including the ATOM study for male osteoporosis, the wearABLe study, and the EMERALD study, is expected to be completed in 2020 with data read-outs anticipated in the second half of 2021[1].

• Label Updates: The FDA updated the TYMLOS label to reflect its mechanism of action in building new bone and removed the boxed warning regarding the potential risk of osteosarcoma, further enhancing its market appeal[2].

Competitive Landscape

The osteoporosis market is evolving with new entrants and changing treatment paradigms:

• Competitors: TYMLOS competes directly with Forteo and will soon face competition from Amgen’s Evenity (romosozumab), which offers a once-monthly dosing regimen and a novel mechanism of action. However, TYMLOS's efficacy and pricing advantages position it well against these competitors[3][4].

• Treatment Paradigms: The market is stratifying into different lines of therapy, with payers likely to require patients to start with generic bisphosphonates before moving to more expensive anabolic agents like TYMLOS[3].

Coverage and Access

TYMLOS has strong coverage across various insurance plans, which aids in its market penetration:

• Insurance Coverage: TYMLOS is covered for approximately 290 million U.S. insured lives, including 99% of commercial and 83% of Medicare Part D insured lives. This coverage has been enhanced by decisions from major insurers like Aetna, CIGNA, and Anthem[1].

Key Takeaways

• Market Leadership: TYMLOS has established itself as a leader in the anabolic osteoporosis market, capturing a significant share of new patient starts.
• Financial Growth: The drug has shown consistent revenue growth and improved financial metrics, including reduced net loss and improved adjusted EBITDA.
• Pipeline Advancements: Ongoing Phase 3 studies and label updates are expected to further enhance TYMLOS's market position.
• Competitive Advantage: TYMLOS's pricing and efficacy advantages position it well against competitors like Forteo and upcoming drugs like Evenity.

FAQs

What is TYMLOS used for?

TYMLOS (abaloparatide) is used for the treatment of postmenopausal women with osteoporosis at high risk of fracture.

How does TYMLOS compare to Forteo?

TYMLOS is priced lower than Forteo and has shown better efficacy in clinical trials, making it a competitive alternative in the anabolic osteoporosis market.

What are the future financial projections for TYMLOS?

For 2022, Radius Health projects TYMLOS net revenue to be $232 million, with a net loss between $5 million and $5 million, and adjusted EBITDA between $35 million and $45 million.

What are the key Phase 3 studies for TYMLOS?

The key Phase 3 studies include the ATOM study for male osteoporosis, the wearABLe study, and the EMERALD study, with recruitment expected to be completed in 2020.

How does TYMLOS fit into the evolving osteoporosis treatment paradigm?

TYMLOS is part of a stratified treatment approach where patients typically start with generic bisphosphonates before moving to anabolic agents like TYMLOS, based on their fracture risk and treatment response.

Sources

1. Radius Health Announces Fourth Quarter and Full-Year 2019 Operating Results. Biospace.
2. Radius Health, Inc. Fourth Quarter & Full Year 2021 Results. Biospace.
3. Tymlos: A new force in the osteoporosis market. Equinox Group.
4. Global osteoporosis market to reach $11.2bn by 2027. Pharmaceutical Technology.
5. Radius Health, Inc. Fourth Quarter & Full Year 2021 Results. GlobeNewswire.