Ubrelvy is a drug owned by Abbvie Inc. It is protected by 9 US drug patents filed from 2020 to 2024 out of which none have expired yet. Ubrelvy's patents have been open to challenges since 24 December, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 22, 2041. Details of Ubrelvy'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. | |||
| US8912210 | Piperidinone carboxamide azaindane CGRP receptor antagonists |
Dec, 2033
(9 years from now) | Active |
| US8754096 | Piperidinone carboxamide azaindane CGRP receptor antagonists |
Jul, 2032
(7 years from now) | Active |
| US9499545 | Piperidinone carboxamide azaindane CGRP receptor antagonists |
Nov, 2031
(6 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). | |||
| US12070450 | Treatment of migraine |
Dec, 2041
(17 years from now) | Active |
| US11717515 | Treatment of migraine |
Dec, 2041
(17 years from now) | Active |
| US11857542 | Treatment of migraine |
Dec, 2041
(17 years from now) | Active |
| US10117836 | Tablet formulation for CGRP active compounds |
Jan, 2035
(10 years from now) | Active |
| US11925709 | Tablet formulation for CGRP active compounds |
Jan, 2035
(10 years from now) | Active |
| US9833448 | Piperidinone carboxamide azaindane CGRP receptor antagonists |
Nov, 2031
(6 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 Ubrelvy's patents.
Latest Legal Activities on Ubrelvy's Patents
Given below is the list of recent legal activities going on the following patents of Ubrelvy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Apr, 2024 | US9499545 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Mar, 2024 | US11925709 |
| Email Notification Critical | 22 Feb, 2024 | US11925709 |
| Issue Notification Mailed Critical | 21 Feb, 2024 | US11925709 |
| transaction for FDA Determination of Regulatory Review Period | 14 Feb, 2024 | US9499545 |
| transaction for FDA Determination of Regulatory Review Period | 14 Feb, 2024 | US8754096 |
| Dispatch to FDC | 09 Feb, 2024 | US11925709 |
| Application Is Considered Ready for Issue Critical | 09 Feb, 2024 | US11925709 |
| Issue Fee Payment Received Critical | 05 Feb, 2024 | US11925709 |
| Issue Fee Payment Verified Critical | 05 Feb, 2024 | US11925709 |
FDA has granted several exclusivities to Ubrelvy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ubrelvy, 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 Ubrelvy.
Exclusivity Information
Ubrelvy holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Ubrelvy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 23, 2024 |
US patents provide insights into the exclusivity only within the United States, but Ubrelvy 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 Ubrelvy's family patents as well as insights into ongoing legal events on those patents.
Ubrelvy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ubrelvy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 22, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ubrelvy Generics:
There are no approved generic versions for Ubrelvy as of now.
Alternative Brands for Ubrelvy
Ubrelvy which is used for the acute treatment of migraines in adults with or without aura, including those with severe hepatic or renal impairment., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Scilex Pharms |
| |||
About Ubrelvy
Ubrelvy is a drug owned by Abbvie Inc. It is used for the acute treatment of migraines in adults with or without aura, including those with severe hepatic or renal impairment. Ubrelvy uses Ubrogepant as an active ingredient. Ubrelvy was launched by Abbvie in 2019.
Approval Date:
Ubrelvy was approved by FDA for market use on 23 December, 2019.
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 Ubrelvy is 23 December, 2019, its NCE-1 date is estimated to be 24 December, 2023.
Active Ingredient:
Ubrelvy uses Ubrogepant as the active ingredient. Check out other Drugs and Companies using Ubrogepant ingredient
Treatment:
Ubrelvy is used for the acute treatment of migraines in adults with or without aura, including those with severe hepatic or renal impairment.
Dosage:
Ubrelvy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |