ABALOPARATIDE - Generic Drug Details

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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.

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
Jacqueline Kernaghan	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	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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
>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
Slovenia	2957278		⤷ Sign Up
Japan	2022516228	副甲状腺ホルモン（ＰＴＨ）および副甲状腺ホルモン関連ペプチド（ＰＴＨＲＰ）アナログに対する中和抗体を検出するための方法	⤷ Sign Up
European Patent Office	2073789	COMPOSITION STABLE D'UNE PROTÉINE ANABOLIQUE OSSEUSE QUI EST UN ANALOGUE DE PTHRP, ET SES EMPLOIS (A STABLE COMPOSITION COMPRISING A BONE ANABOLIC PROTEIN, NAMELY A PTHRP ANALOGUE, AND USES THEREOF)	⤷ 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	LUC00309	Luxembourg	⤷ Sign Up	PRODUCT NAME: ABALOPARATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1706 20221213
2073789	122023000031	Germany	⤷ Sign Up	PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 20221212
2073789	CA 2023 00019	Denmark	⤷ Sign Up	PRODUCT NAME: ABALOPARATID; REG. NO/DATE: EU/1/22/1706 20221213
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.