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Last Updated: October 27, 2020

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FORTEO Drug Profile

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When do Forteo patents expire, and when can generic versions of Forteo launch?

Forteo is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twenty-four countries.

The generic ingredient in FORTEO is teriparatide. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the teriparatide profile page.

US ANDA Litigation and Generic Entry Outlook for Forteo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 25, 2025. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases 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 FORTEO
Drug Prices for FORTEO

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Generic Entry Opportunity Date for FORTEO
Generic Entry Date for FORTEO*:
Constraining patent/regulatory exclusivity:
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 FORTEO

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

SponsorPhase
University of South CarolinaPhase 4
Washington University School of MedicinePhase 4
VA Office of Research and DevelopmentPhase 4

See all FORTEO clinical trials

Pharmacology for FORTEO
Paragraph IV (Patent) Challenges for FORTEO
Tradename Dosage Ingredient NDA Submissiondate
FORTEO SOLUTION;SUBCUTANEOUS teriparatide 021318 2015-07-27

US Patents and Regulatory Information for FORTEO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-001 Nov 26, 2002 DISCN No No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FORTEO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008   Start Trial   Start Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-001 Nov 26, 2002   Start Trial   Start Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.