Nurtec Odt is a drug owned by Pfizer Inc. It is protected by 3 US drug patents filed from 2020 to 2021 out of which none have expired yet. Nurtec Odt's patents have been open to challenges since 28 February, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 25, 2039. Details of Nurtec Odt'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. | |||
| US8759372 | N-(5S,6S,9R)-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-ctclohepta[b]Pyridin-9-yl-4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-carboxylate salt |
Feb, 2033
(8 years from now) | Active |
| US8314117 | CGRP receptor antagonists |
Mar, 2030
(5 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). | |||
| US11083724 | Rimegepant for CGRP related disorders |
Mar, 2039
(14 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 Nurtec Odt's patents.
Latest Legal Activities on Nurtec Odt's Patents
Given below is the list of recent legal activities going on the following patents of Nurtec Odt.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Apr, 2024 | US8314117 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 13 Aug, 2023 | US8314117 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Jun, 2023 | US8314117 |
| Email Notification Critical | 30 Jun, 2023 | US8314117 |
| Electronic Review Critical | 30 Jun, 2023 | US8314117 |
| Terminal Disclaimer Filed Critical | 27 Jun, 2023 | US8314117 |
| Notice of Final Determination -Eligible | 30 May, 2023 | US8759372 |
| Notice of Final Determination -Eligible | 30 May, 2023 | US8314117 |
| FDA Final Eligibility Letter Critical | 10 May, 2023 | US8314117 |
| FDA Final Eligibility Letter Critical | 10 May, 2023 | US8759372 |
FDA has granted several exclusivities to Nurtec Odt. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nurtec Odt, 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 Nurtec Odt.
Exclusivity Information
Nurtec Odt holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Nurtec Odt's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-865) | May 27, 2024 |
| New Chemical Entity Exclusivity(NCE) | Feb 27, 2025 |
US patents provide insights into the exclusivity only within the United States, but Nurtec Odt 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 Nurtec Odt's family patents as well as insights into ongoing legal events on those patents.
Nurtec Odt's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nurtec Odt's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 25, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nurtec Odt Generics:
There are no approved generic versions for Nurtec Odt as of now.
About Nurtec Odt
Nurtec Odt is a drug owned by Pfizer Inc. It is used for preventing episodic migraine in adults. Nurtec Odt uses Rimegepant Sulfate as an active ingredient. Nurtec Odt was launched by Pfizer in 2020.
Approval Date:
Nurtec Odt was approved by FDA for market use on 27 February, 2020.
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 Nurtec Odt is 27 February, 2020, its NCE-1 date is estimated to be 28 February, 2024.
Active Ingredient:
Nurtec Odt uses Rimegepant Sulfate as the active ingredient. Check out other Drugs and Companies using Rimegepant Sulfate ingredient
Treatment:
Nurtec Odt is used for preventing episodic migraine in adults.
Dosage:
Nurtec Odt is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 75MG BASE | TABLET, ORALLY DISINTEGRATING | Prescription | ORAL |