Retevmo is a drug owned by Loxo Oncology A Wholly Owned Sub Of Eli Lilly And Company. It is protected by 5 US drug patents filed from 2020 to 2024 out of which none have expired yet. Retevmo's patents have been open to challenges since 08 May, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 10, 2038. Details of Retevmo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10584124 | Crystalline forms |
Oct, 2038
(13 years from now) | Active |
| US10112942 | Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors |
Oct, 2037
(12 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10786489 | Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carbonitrile |
Oct, 2038
(13 years from now) | Active |
| US10172851 | Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors |
Oct, 2037
(12 years from now) | Active |
| US10137124 | Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors |
Oct, 2037
(12 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 Retevmo's patents.
Latest Legal Activities on Retevmo's Patents
Given below is the list of recent legal activities going on the following patents of Retevmo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 21 Feb, 2024 | US10786489 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Aug, 2023 | US10584124 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jun, 2022 | US10172851 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Apr, 2022 | US10137124 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Mar, 2022 | US10112942 |
| Post Issue Communication - Certificate of Correction | 25 Nov, 2020 | US10786489 |
| Sequence Moved to Public Database | 29 Sep, 2020 | US10786489 |
| Recordation of Patent Grant Mailed Critical | 29 Sep, 2020 | US10786489 |
| Patent Issue Date Used in PTA Calculation Critical | 29 Sep, 2020 | US10786489 |
| Email Notification Critical | 15 Sep, 2020 | US10786489 |
FDA has granted several exclusivities to Retevmo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Retevmo, 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 Retevmo.
Exclusivity Information
Retevmo holds 10 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Retevmo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 08, 2025 |
| Orphan Drug Exclusivity(ODE-301) | May 08, 2027 |
| Orphan Drug Exclusivity(ODE-302) | May 08, 2027 |
| Orphan Drug Exclusivity(ODE-303) | May 08, 2027 |
| New Patient Population(NPP) | May 29, 2027 |
| Orphan Drug Exclusivity(ODE-409) | Sep 21, 2029 |
| Orphan Drug Exclusivity(ODE-412) | Sep 21, 2029 |
| Orphan Drug Exclusivity(ODE-484) | May 29, 2031 |
| Orphan Drug Exclusivity(ODE-485) | May 29, 2031 |
| Orphan Drug Exclusivity(ODE-487) | May 29, 2031 |
US patents provide insights into the exclusivity only within the United States, but Retevmo 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 Retevmo's family patents as well as insights into ongoing legal events on those patents.
Retevmo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Retevmo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 10, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Retevmo Generics:
There are no approved generic versions for Retevmo as of now.
About Retevmo
Retevmo is a drug owned by Loxo Oncology A Wholly Owned Sub Of Eli Lilly And Company. It is used for treating advanced or metastatic thyroid cancer and non-small cell lung cancer with specific genetic mutations that are refractory to other treatments. Retevmo uses Selpercatinib as an active ingredient. Retevmo was launched by Loxo Oncol Eli Lilly in 2024.
Approval Date:
Retevmo was approved by FDA for market use on 10 April, 2024.
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 Retevmo is 10 April, 2024, its NCE-1 date is estimated to be 08 May, 2024.
Active Ingredient:
Retevmo uses Selpercatinib as the active ingredient. Check out other Drugs and Companies using Selpercatinib ingredient
Treatment:
Retevmo is used for treating advanced or metastatic thyroid cancer and non-small cell lung cancer with specific genetic mutations that are refractory to other treatments.
Dosage:
Retevmo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG | TABLET | Prescription | ORAL |
| 80MG | TABLET | Prescription | ORAL |
| 120MG | TABLET | Prescription | ORAL |
| 160MG | TABLET | Prescription | ORAL |