Qulipta is a drug owned by Abbvie Inc. It is protected by 4 US drug patents filed in 2021 out of which none have expired yet. Qulipta's patents will be open to challenges from 28 September, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 30, 2035. Details of Qulipta'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. | |||
| US9850246 | Process for making CGRP receptor antagonists |
Mar, 2033
(8 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). | |||
| US10117836 | Tablet formulation for CGRP active compounds |
Jan, 2035
(10 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 Qulipta's patents.
Latest Legal Activities on Qulipta's Patents
Given below is the list of recent legal activities going on the following patents of Qulipta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Apr, 2024 | US9499545 |
| transaction for FDA Determination of Regulatory Review Period | 14 Feb, 2024 | US9499545 |
| transaction for FDA Determination of Regulatory Review Period | 14 Feb, 2024 | US8754096 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US8754096 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9499545 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 May, 2023 | US9850246 |
| Email Notification Critical | 26 May, 2023 | US9499545 |
| Electronic Review Critical | 26 May, 2023 | US9499545 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 May, 2023 | US9499545 |
| Electronic Review Critical | 26 May, 2023 | US9850246 |
FDA has granted several exclusivities to Qulipta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qulipta, 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 Qulipta.
Exclusivity Information
Qulipta holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Qulipta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-909) | Apr 17, 2026 |
| New Chemical Entity Exclusivity(NCE) | Sep 28, 2026 |
US patents provide insights into the exclusivity only within the United States, but Qulipta 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 Qulipta's family patents as well as insights into ongoing legal events on those patents.
Qulipta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Qulipta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 30, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qulipta Generics:
There are no approved generic versions for Qulipta as of now.
About Qulipta
Qulipta is a drug owned by Abbvie Inc. It is used for preventing migraine attacks in adults. Qulipta uses Atogepant as an active ingredient. Qulipta was launched by Abbvie in 2021.
Approval Date:
Qulipta was approved by FDA for market use on 28 September, 2021.
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 Qulipta is 28 September, 2021, its NCE-1 date is estimated to be 28 September, 2025.
Active Ingredient:
Qulipta uses Atogepant as the active ingredient. Check out other Drugs and Companies using Atogepant ingredient
Treatment:
Qulipta is used for preventing migraine attacks in adults.
Dosage:
Qulipta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 30MG | TABLET | Prescription | ORAL |
| 60MG | TABLET | Prescription | ORAL |