Tymlos is a drug owned by Radius Health Inc. It is protected by 9 US drug patents filed from 2017 to 2024 out of which none have expired yet. Tymlos's patents have been open to challenges since 28 April, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 10, 2040. Details of Tymlos'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). | |||
| US11680942 | Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) analog |
Jan, 2040
(14 years from now) | Active |
| US11255842 | Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHRP) analog |
Jan, 2040
(14 years from now) | Active |
| US10996208 | Abaloparatide formulations and methods of testing, storing, modifying, and using same |
Apr, 2038
(12 years from now) | Active |
| US11782041 | Abaloparatide formulations and methods of testing, storing, modifying, and using same |
Apr, 2038
(12 years from now) | Active |
| US11977067 | Abaloparatide formulations and methods of testing, storing, modifying, and using same |
Apr, 2038
(12 years from now) | Active |
| USRE49444 | Method of treating osteoporosis comprising administration of PTHrP analog |
Apr, 2031
(5 years from now) | Active |
| US7803770 | Method of treating osteoporosis comprising administration of PTHrP analog |
Apr, 2031
(5 years from now) | Active |
| US8148333 | Stable composition comprising a PTHrP analogue |
Nov, 2027
(2 years from now) | Active |
| US8748382 | Method of drug delivery for bone anabolic protein |
Oct, 2027
(2 years from now) | Active |
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 Tymlos's patents.
Latest Legal Activities on Tymlos's Patents
Given below is the list of recent legal activities going on the following patents of Tymlos.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 11 Oct, 2023 | US11782041 |
| Recordation of Patent eGrant | 10 Oct, 2023 | US11782041 |
| Recordation of Patent Grant Mailed Critical | 10 Oct, 2023 | US11782041 |
| Sequence Moved to Public Database | 10 Oct, 2023 | US11782041 |
| Patent Issue Date Used in PTA Calculation Critical | 10 Oct, 2023 | US11782041 |
| Mail Patent eGrant Notification | 10 Oct, 2023 | US11782041 |
| Patent eGrant Notification | 10 Oct, 2023 | US11782041 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Oct, 2023 | US8148333 |
| Email Notification Critical | 21 Sep, 2023 | US11782041 |
| Issue Notification Mailed Critical | 20 Sep, 2023 | US11782041 |
FDA has granted several exclusivities to Tymlos. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tymlos, 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 Tymlos.
Exclusivity Information
Tymlos holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Tymlos's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 28, 2022 |
| M(M-270) | Sep 20, 2024 |
| New Indication(I-907) | Dec 19, 2025 |
Several oppositions have been filed on Tymlos's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tymlos's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tymlos patents.
Tymlos's Oppositions Filed in EPO
Tymlos has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 16, 2018, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP15176548A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15176548A | Feb, 2018 | Isenbruck Bösl Hörschler LLP | Revoked |
| EP15176548A | Feb, 2018 | Teva Pharmaceutical Industries Ltd | Revoked |
US patents provide insights into the exclusivity only within the United States, but Tymlos 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 Tymlos's family patents as well as insights into ongoing legal events on those patents.
Tymlos's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tymlos's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 10, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tymlos Generics:
There are no approved generic versions for Tymlos as of now.
How can I launch a generic of Tymlos before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tymlos's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tymlos'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 Tymlos -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3.12 mg/1.56 mL | 21 Jun, 2022 | 1 | 10 Jan, 2040 |
About Tymlos
Tymlos is a drug owned by Radius Health Inc. It is used for increasing bone density and reducing fracture risk in postmenopausal women and men with osteoporosis, as well as for detecting neutralizing antibodies. Tymlos uses Abaloparatide as an active ingredient. Tymlos was launched by Radius in 2017.
Approval Date:
Tymlos was approved by FDA for market use on 28 April, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tymlos is 28 April, 2017, its NCE-1 date is estimated to be 28 April, 2021.
Active Ingredient:
Tymlos uses Abaloparatide as the active ingredient. Check out other Drugs and Companies using Abaloparatide ingredient
Treatment:
Tymlos is used for increasing bone density and reducing fracture risk in postmenopausal women and men with osteoporosis, as well as for detecting neutralizing antibodies.
Dosage:
Tymlos is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3.12MG/1.56ML (2MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |