Forteo Patent Expiration

Forteo is a drug owned by Eli Lilly And Co. It is protected by 7 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 25, 2025. Details of Forteo's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7144861 Stabilized teriparatide solutions
Dec, 2018

(5 years ago)

Expired
US7550434 Stabilized teriparatide solutions
Dec, 2018

(5 years ago)

Expired
US6770623 Stabilized teriparatide solutions
Dec, 2018

(5 years ago)

Expired
US7351414 Method of reducing the risk of bone fracture
Aug, 2019

(4 years ago)

Expired
US6977077 Method of increasing bone toughness and stiffness and reducing fractures
Aug, 2019

(4 years ago)

Expired
US7163684 Method of increasing bone toughness and stiffness and reducing fractures
Aug, 2019

(4 years ago)

Expired
US7517334 Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Mar, 2025

(8 months from now)

Active


FDA has granted several exclusivities to Forteo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Forteo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Forteo.

Exclusivity Information

Forteo holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Forteo's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-602) Jul 22, 2012
M(M-302) Nov 16, 2023

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US patents provide insights into the exclusivity only within the United States, but Forteo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Forteo's family patents as well as insights into ongoing legal events on those patents.

Forteo's family patents

Forteo has patent protection in a total of 25 countries. It's US patent count contributes only to 17.1% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Forteo.

Family Patents

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Generic Launch

Generic Release Date:

Forteo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 25, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Forteo Generics:

Teriparatide is the generic name for the brand Forteo. 2 different companies have already filed for the generic of Forteo, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Forteo's generic

How can I launch a generic of Forteo before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Forteo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Forteo's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Forteo -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
250 mcg/mL, 2.4 mL prefilled Pen 27 Jul, 2015 1 25 Mar, 2025




About Forteo

Forteo is a drug owned by Eli Lilly And Co. It is used for reducing the risk of bone fractures in post-menopausal women with osteoporosis. Forteo uses Teriparatide as an active ingredient. Forteo was launched by Lilly in 2008.

Market Authorisation Date:

Forteo was approved by FDA for market use on 25 June, 2008.

Active Ingredient:

Forteo uses Teriparatide as the active ingredient. Check out other Drugs and Companies using Teriparatide ingredient

Treatment:

Forteo is used for reducing the risk of bone fractures in post-menopausal women with osteoporosis.

Dosage:

Forteo is available in solution form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.75MG/3ML (0.25MG/ML) SOLUTION Discontinued SUBCUTANEOUS
0.6MG/2.4ML (0.25MG/ML) SOLUTION Prescription SUBCUTANEOUS