Abaloparatide - Generic Drug Details

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What are the generic sources for abaloparatide and what is the scope of patent protection?

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

Generic Entry Date for abaloparatide^: ⤷ Sign Up* 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
University of Vermont	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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Radius	TYMLOS	abaloparatide	SOLUTION;SUBCUTANEOUS	208743-001	Apr 28, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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/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
>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
Poland	2957278		⤷ Sign Up
Brazil	PI0719821	composiÇço estÁvel na armazenagem apropriada para administraÇço a pacientes e mÉtodo de tratamento de osteoporose nestes	⤷ Sign Up
Japan	2010505835		⤷ Sign Up
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.)	⤷ Sign Up
>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	301235	Netherlands	⤷ Sign Up	PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213
2073789	2390018-6	Sweden	⤷ Sign Up	PRODUCT NAME: ABALOPARATIDE; REG. NO/DATE: EU/1/22/1706 20221213
2073789	23/2023	Austria	⤷ Sign Up	PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 (MITTEILUNG) 20221213
2073789	2023C/523	Belgium	⤷ Sign Up	PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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