Last Updated: September 24, 2026

ABALOPARATIDE - Generic Drug Details

Name: ABALOPARATIDE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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.

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

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

Generic Entry Date for ABALOPARATIDE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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

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Glossary

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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	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for ABALOPARATIDE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ABALOPARATIDE

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Country	Patent Number	Title	Estimated Expiration
Australia	2020207653		⤷ Start Trial
Brazil	112021011566		⤷ Start Trial
Canada	3122231		⤷ Start Trial
China	113286818		⤷ Start Trial
Colombia	2021007715		⤷ Start Trial
European Patent Office	3908605		⤷ Start Trial
Israel	284533		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ABALOPARATIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2073789	23C1024	France	⤷ Start Trial	PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213
2073789	C202330026	Spain	⤷ Start Trial	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	CA 2023 00019	Denmark	⤷ Start Trial	PRODUCT NAME: ABALOPARATID; REG. NO/DATE: EU/1/22/1706 20221213
2073789	LUC00309	Luxembourg	⤷ Start Trial	PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213
2073789	SPC/GB23/020	United Kingdom	⤷ Start Trial	PRODUCT NAME: ABALOPARATIDE; REGISTERED: UK EU/1/22/1706(FOR NI) 20221213; UK MORE ON HISTORY TAB 20221213
2073789	2023C/523	Belgium	⤷ Start Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
2073789	C02073789/01	Switzerland	⤷ Start Trial	PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69246 07.03.2024
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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