Augtyro is a drug owned by Bristol Myers Squibb Co. It is protected by 3 US drug patents filed in 2023 out of which none have expired yet. Augtyro's patents will be open to challenges from 16 November, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 24, 2036. Details of Augtyro'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. | |||
| US10294242 | Diaryl macrocycle polymorph |
Jul, 2036
(11 years from now) | Active |
| US9714258 | Diaryl macrocycles as modulators of protein kinases |
Jan, 2035
(10 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). | |||
| US11452725 | Chiral diaryl macrocycles and uses thereof |
Jul, 2036
(11 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 Augtyro's patents.
Latest Legal Activities on Augtyro's Patents
Given below is the list of recent legal activities going on the following patents of Augtyro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Initial letter Re: PTE Application to regulating agency | 16 Feb, 2024 | US9714258 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 15 Feb, 2024 | US9714258 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 Jan, 2024 | US9714258 |
| Email Notification Critical | 22 Jan, 2024 | US9714258 |
| Requirement for information sent under 37 CFR 1.750 | 16 Jan, 2024 | US9714258 |
| Patent Term Extension Application under 35 USC 156 Filed | 11 Jan, 2024 | US9714258 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Nov, 2023 | US9714258 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 15 Nov, 2022 | US11452725 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Nov, 2022 | US10294242 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 26 Oct, 2022 | US10294242 |
FDA has granted several exclusivities to Augtyro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Augtyro, 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 Augtyro.
Exclusivity Information
Augtyro holds 5 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Augtyro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 15, 2028 |
| ODE*(ODE*) | Nov 15, 2030 |
| Orphan Drug Exclusivity(ODE-455) | Nov 15, 2030 |
| Orphan Drug Exclusivity(ODE-483) | Jun 13, 2031 |
| Orphan Drug Exclusivity(ODE-488) | Jun 13, 2031 |
US patents provide insights into the exclusivity only within the United States, but Augtyro 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 Augtyro's family patents as well as insights into ongoing legal events on those patents.
Augtyro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Augtyro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 24, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Augtyro Generics:
There are no approved generic versions for Augtyro as of now.
About Augtyro
Augtyro is a drug owned by Bristol Myers Squibb Co. It is used for treating locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adult patients. Augtyro uses Repotrectinib as an active ingredient. Augtyro was launched by Bristol in 2023.
Approval Date:
Augtyro was approved by FDA for market use on 15 November, 2023.
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 Augtyro is 15 November, 2023, its NCE-1 date is estimated to be 16 November, 2027.
Active Ingredient:
Augtyro uses Repotrectinib as the active ingredient. Check out other Drugs and Companies using Repotrectinib ingredient
Treatment:
Augtyro is used for treating locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adult patients.
Dosage:
Augtyro is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 160MG | CAPSULE | Prescription | ORAL |
| 40MG | CAPSULE | Prescription | ORAL |