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 which all 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7517334 | Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose |
Mar, 2025
(a month ago) |
Expired
|
| US7351414 | Method of reducing the risk of bone fracture |
Aug, 2019
(5 years ago) |
Expired
|
| US6977077 | Method of increasing bone toughness and stiffness and reducing fractures |
Aug, 2019
(5 years ago) |
Expired
|
| US7163684 | Method of increasing bone toughness and stiffness and reducing fractures |
Aug, 2019
(5 years ago) |
Expired
|
| US7550434 | Stabilized teriparatide solutions |
Dec, 2018
(6 years ago) |
Expired
|
| US7144861 | Stabilized teriparatide solutions |
Dec, 2018
(6 years ago) |
Expired
|
| US6770623 | Stabilized teriparatide solutions |
Dec, 2018
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Forteo's patents.
Latest Legal Activities on Forteo's Patents
Given below is the list of recent legal activities going on the following patents of Forteo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 26 Jul, 2021 | US7550434 |
| Maintenance Fee Reminder Mailed Critical | 08 Feb, 2021 | US7550434 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Sep, 2020 | US7517334 |
| Expire Patent Critical | 04 May, 2020 | US7351414 |
| Maintenance Fee Reminder Mailed Critical | 18 Nov, 2019 | US7351414 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jun, 2018 | US7163684 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 May, 2018 | US7144861 (Litigated) |
| Post Issue Communication - Certificate of Correction | 17 Dec, 2009 | US7550434 |
| Sequence Moved to Public Database | 06 Jul, 2009 | US7550434 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Jun, 2009 | US7550434 |
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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Forteo
Forteo which is used for reducing the risk of bone fractures in post-menopausal women with osteoporosis., has several other brand drugs using the same active ingredient (Teriparatide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Ascendis Pharma Bone |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Teriparatide, Forteo's active ingredient. Check the complete list of approved generic manufacturers for Forteo
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.
Approval 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 |
|---|---|---|---|
| 0.56MG/2.24ML (0.25MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 0.75MG/3ML (0.25MG/ML) | SOLUTION | Discontinued | SUBCUTANEOUS |