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Last Updated: April 22, 2024

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 eight 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.

Drug Prices for abaloparatide

See drug prices for abaloparatide

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for abaloparatide
Generic Entry 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

SponsorPhase
Daniel HorwitzPhase 4
Johns Hopkins UniversityPhase 2
Crozer-Keystone Health SystemPhase 4

See all abaloparatide clinical trials

Pharmacology for abaloparatide
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Radius TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Radius TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Radius TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Radius TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

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

Country Patent Number Title Estimated Expiration
Russian Federation 2506070 СПОСОБ ЛЕЧЕНИЯ ОСТЕОПОРОЗА И ИСПОЛЬЗУЕМАЯ В НЕМ КОМПОЗИЦИЯ (METHOD OF TREATING OSTEOPOROSIS AND COMPOSITION USED THEREIN) ⤷  Try a Trial
Denmark 2073789 ⤷  Try a Trial
Russian Federation 2009116531 СПОСОБ ЛЕЧЕНИЯ ОСТЕОПОРОЗА И ИСПОЛЬЗУЕМАЯ В НЕМ КОМПОЗИЦИЯ ⤷  Try a Trial
Norway 344885 ⤷  Try a Trial
South Korea 20150020289 METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for abaloparatide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2073789 301235 Netherlands ⤷  Try a Trial PRODUCT NAME: ABALOPARATIDE; REGISTRATION NO/DATE: EU/1/22/1706 20221213
2073789 23/2023 Austria ⤷  Try a Trial PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 (MITTEILUNG) 20221213
2073789 122023000031 Germany ⤷  Try a Trial PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 20221212
2073789 CA 2023 00019 Denmark ⤷  Try a Trial PRODUCT NAME: ABALOPARATID; REG. NO/DATE: EU/1/22/1706 20221213
2073789 LUC00309 Luxembourg ⤷  Try a Trial 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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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.