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Last Updated: March 29, 2024

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TYMLOS Drug Patent Profile


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When do Tymlos patents expire, and what generic alternatives are available?

Tymlos is a drug marketed by Radius and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-eight countries.

The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this compound. Additional details are available on the abaloparatide profile page.

DrugPatentWatch® Generic Entry Outlook for Tymlos

Tymlos was eligible for patent challenges on April 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2025. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TYMLOS
Drug Prices for TYMLOS

See drug prices for TYMLOS

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TYMLOS
Generic Entry Date for TYMLOS*:
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
NDA:
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 TYMLOS

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

SponsorPhase
Felicia Cosman, MDPhase 4
University of VermontPhase 2
Crozer-Keystone Health SystemPhase 4

See all TYMLOS clinical trials

Pharmacology for TYMLOS
Paragraph IV (Patent) Challenges for TYMLOS
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 TYMLOS

TYMLOS is protected by eleven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TYMLOS is ⤷  Try a Trial.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TYMLOS

Abaloparatide formulations and methods of testing, storing, modifying, and using same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHRP) analog
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR DETECTING NEUTRALIZING ANTIBODIES


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE FOR DETECTING NEUTRALIZING ANTIBODIES


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE

Method of treating osteoporosis comprising administration of PTHrP analog
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.

Stable composition comprising a PTHrP analogue
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method of drug delivery for bone anabolic protein
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE

Method of drug delivery for bone anabolic protein
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE

FDA Regulatory Exclusivity protecting TYMLOS

INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
Exclusivity Expiration: ⤷  Try a Trial

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
Exclusivity Expiration: ⤷  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
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
>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 TYMLOS

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 TYMLOS

See the table below for patents covering TYMLOS around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2020144653 ⤷  Try a Trial
South Korea 20210120009 부갑상선 호르몬(PTH) 및 부갑상선 호르몬-관련 펩티드(PTHRP) 유사체에 대한 중화 항체의 검출 방법 ⤷  Try a Trial
Spain 2739459 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TYMLOS

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 122023000031 Germany ⤷  Try a Trial PRODUCT NAME: ABALOPARATID; REGISTRATION NO/DATE: EU/1/22/1706 20221212
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.