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Last Updated: April 3, 2020

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TYMLOS Drug Profile


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Which patents cover Tymlos, and what generic alternatives are available?

Tymlos is a drug marketed by Radius Health Inc and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-seven patent family members in twenty-five countries.

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

US ANDA Litigation and Generic Entry Outlook for Tymlos

Tymlos will be eligible for patent challenges on April 28, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 28, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TYMLOS
International Patents:37
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 3
Clinical Trials: 3
Drug Prices: Drug price information for TYMLOS
DailyMed Link:TYMLOS at DailyMed
Drug patent expirations by year for TYMLOS
Drug Prices for TYMLOS

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Generic Entry Opportunity Date for TYMLOS
Generic Entry Date for TYMLOS*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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
Weill Medical College of Cornell UniversityPhase 2
Lenox Hill HospitalPhase 2
New York Hospital QueensPhase 2

See all TYMLOS clinical trials

Pharmacology for TYMLOS
Synonyms for TYMLOS
247062-33-5
Abaloparatide
Abaloparatide [USAN:INN]
Abaloparatide-SC
BA058
BDBM50246337
BIM-44058
C2.29-methyl(22-L-glutamic acid(F>E),23-L-leucine(F>L),25-L-glutamic acid(H>E),26-L-lysine(H>K),28-L-leucine(I>L),30-L-lysine(E>K),31-L-leucine(I>L))human parathyroid hormone-related protein-(1-34)-proteinamide
CHEMBL4084894

US Patents and Regulatory Information for TYMLOS

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   Start Trial   Start Trial   Start Trial
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Radius Health Inc TYMLOS abaloparatide SOLUTION;SUBCUTANEOUS 208743-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Harvard Business School
Mallinckrodt
McKinsey
Medtronic

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.