DrugPatentWatch Database Preview
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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-seven patent family members in twenty-five 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.
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
Summary for FORTEO
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||25|
|Drug Prices:||Drug price information for FORTEO|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for FORTEO|
|What excipients (inactive ingredients) are in FORTEO?||FORTEO excipients list|
|DailyMed Link:||FORTEO at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for FORTEO
*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
|Daniel Horwitz||Phase 4|
|Radius Health, Inc.||Phase 4|
|Eisenhower Army Medical Center||Phase 4|
Pharmacology for FORTEO
|Drug Class||Parathyroid Hormone Analog |
FORTEO is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FORTEO is ⤷ Sign up for a Free Trial.
This potential generic entry date is based on patent ⤷ Sign up for a Free Trial.
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 FORTEO
Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Patent Number: ⤷ Sign up for a Free Trial
Patent Expiration: ⤷ Sign up for a Free Trial
|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||⤷ Sign up for a Free Trial||⤷ Sign up for a Free Trial||Y||⤷ Sign up for a Free Trial|
|Lilly||FORTEO||teriparatide||SOLUTION;SUBCUTANEOUS||021318-001||Nov 26, 2002||DISCN||No||No||⤷ Sign up for a Free Trial||⤷ Sign up for a Free Trial||Y||⤷ Sign up for a Free Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Country||Patent Number||Estimated Expiration|
|Poland||343595||⤷ Sign up for a Free Trial|
|Japan||6177718||⤷ Sign up for a Free Trial|
|Slovenia||1059933||⤷ Sign up for a Free Trial|
|Egypt||23675||⤷ Sign up for a Free Trial|
|Eurasian Patent Organization||003362||⤷ Sign up for a Free Trial|
|Denmark||2907522||⤷ Sign up for a Free Trial|
|Brazil||9813463||⤷ Sign up for a Free Trial|
|>Country||>Patent Number||>Estimated Expiration|