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Last Updated: November 30, 2022

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 Health Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abaloparatide has fifty patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for abaloparatide
International Patents:50
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 5
Clinical Trials: 14
Drug Prices: Drug price trends for abaloparatide
What excipients (inactive ingredients) are in abaloparatide?abaloparatide excipients list
DailyMed Link:abaloparatide at DailyMed
Drug Prices for abaloparatide

See drug prices for abaloparatide

Recent Clinical Trials for abaloparatide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Daniel HorwitzPhase 4
Johns Hopkins UniversityPhase 2
University of VermontPhase 2

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 Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 International Ltd Eladynos abaloparatide EMEA/H/C/004157
Treatment of osteoporosis.
Refused no no no 2019-01-07
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for abaloparatide

Country Patent Number Title Estimated Expiration
Brazil PI0719821 composiÇço estÁvel na armazenagem apropriada para administraÇço a pacientes e mÉtodo de tratamento de osteoporose nestes See Plans and Pricing
New Zealand 576682 METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN PARATHYROID HORMONE-RELATED PROTEIN (PTHrP) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008063279 See Plans and Pricing
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) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009137093 See Plans and Pricing
European Patent Office 3908605 PROCÉDÉS DE DÉTECTION D'ANTICORPS DE NEUTRALISATION DIRIGÉS CONTRE L'HORMONE PARATHYROÏDE (PTH) ET ANALOGUE DE PEPTIDE LIÉ À L'HORMONE PARATHYROÏDE (PTHRP) (METHODS FOR DETECTING NEUTRALIZING ANTIBODIES TO PARATHYROID HORMONE (PTH) AND PARATHYROID HORMONE-RELATED PEPTIDE (PTHRP) ANALOG) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.