Auvelity is a drug owned by Axsome Therapeutics Inc. It is protected by 120 US drug patents filed from 2022 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 20, 2043. Details of Auvelity's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11844797 | Combination of dextromethorphan and bupropion for treating depression |
Apr, 2043
(18 years from now) | Active |
| US11839612 | Compounds and combinations thereof for treating neurological and psychiatric conditions |
Mar, 2043
(18 years from now) | Active |
| US12042473 | Compounds and combinations thereof for treating neurological and psychiatric conditions |
Feb, 2043
(18 years from now) | Active |
| US11752144 | Compounds and combinations thereof for treating neurological and psychiatric conditions |
Feb, 2043
(18 years from now) | Active |
| US12036191 | Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan |
Feb, 2043
(18 years from now) | Active |
| US11986444 | Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan |
Feb, 2043
(18 years from now) | Active |
| US11730706 | Treatment of depression in certain patient populations |
Jan, 2043
(18 years from now) | Active |
| US11883373 | Treatment of depression in certain patient populations |
Jan, 2043
(18 years from now) | Active |
| US11717518 | Bupropion dosage forms with reduced food and alcohol dosing effects |
Jan, 2043
(18 years from now) | Active |
| US11925636 | Bupropion dosage forms with reduced food and alcohol dosing effects |
Jan, 2043
(18 years from now) | Active |
| US11896563 | Bupropion and dextromethorphan for reduction of suicide risk in depression patients |
Dec, 2041
(17 years from now) | Active |
| US10940124 | Bupropion as a modulator of drug activity |
Jan, 2040
(15 years from now) | Active |
| US10925842 | Bupropion as a modulator of drug activity |
Jan, 2040
(15 years from now) | Active |
| US10780064 | Bupropion as a modulator of drug activity |
Jan, 2040
(15 years from now) | Active |
| US10966942 | Bupropion as a modulator of drug activity |
Jan, 2040
(15 years from now) | Active |
| US10780066 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9474731 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9375429 | Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan |
Nov, 2034
(9 years from now) | Active |
| US9421176 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9408815 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9763932 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11311534 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9205083 | Compositions and methods comprising erythrohydroxybupropion and related compounds for improving the efficacy of dextromethorphan |
Nov, 2034
(9 years from now) | Active |
| US9707191 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US10898453 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11433067 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9700528 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9457023 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9238032 | Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan |
Nov, 2034
(9 years from now) | Active |
| US11096937 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11298352 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10966941 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11298351 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11090300 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10894047 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10064857 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11291665 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11291638 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10786469 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11253492 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10881657 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10874663 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10799497 | Combination of dextromethorphan and bupropion for treating depression |
Nov, 2034
(9 years from now) | Active |
| US11058648 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11273133 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10864209 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10806710 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10881624 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US10786496 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11020389 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11185515 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10945973 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11285146 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11285118 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10596167 | Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan |
Nov, 2034
(9 years from now) | Active |
| US11439636 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9314462 | Compositions and methods for increasing dextromethorphan plasma levels and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9198905 | Compositions and methods for reducing dextrorphan plasma levels and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11426401 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11426370 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11419867 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10772850 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11273134 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11253491 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11234946 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10548857 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11229640 | Combination of dextromethorphan and bupropion for treating depression |
Nov, 2034
(9 years from now) | Active |
| US10874665 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10933034 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10251879 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10092561 | Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan |
Nov, 2034
(9 years from now) | Active |
| US10894046 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11191739 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10874664 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10080727 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11197839 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11147808 | Method of decreasing the fluctuation index of dextromethorphan |
Nov, 2034
(9 years from now) | Active |
| US11207281 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11141416 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11141388 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11213521 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11129826 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11123343 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10966974 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US10512643 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US10463634 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US10105361 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US10105327 | Compositions and methods for increasing the metabolic lifetime of dextromethorphane and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US10092560 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9968568 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11969421 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11478468 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11541048 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11524007 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11534414 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11779579 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11617728 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11596627 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11497721 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US12109178 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11524008 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9370513 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11617747 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11541021 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11517542 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11517543 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11510918 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11382874 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11364233 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9457025 | Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan |
Nov, 2034
(9 years from now) | Active |
| US10058518 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9278095 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9867819 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9168234 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9861595 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US9700553 | Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects |
Nov, 2034
(9 years from now) | Active |
| US11357744 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US11344544 | Bupropion as a modulator of drug activity |
Nov, 2034
(9 years from now) | Active |
| US9486450 | Hydroxybupropion and related compounds as modulators of drug plasma levels |
Nov, 2034
(9 years from now) | Active |
| US8569328 | Compositions and methods comprising tilidine or related compounds and dextromethorphan |
Oct, 2033
(8 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 Auvelity's patents.
Latest Legal Activities on Auvelity's Patents
Given below is the list of recent legal activities going on the following patents of Auvelity.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jul, 2024 | US10894047 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Jul, 2024 | US10881657 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Jul, 2024 | US11426401 |
| Email Notification Critical | 02 Jul, 2024 | US11426401 |
| Email Notification Critical | 02 Jul, 2024 | US11439636 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Jul, 2024 | US11439636 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Jul, 2024 | US10881624 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Jun, 2024 | US10780066 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Jun, 2024 | US10786469 |
| Email Notification Critical | 27 Jun, 2024 | US10780066 |
FDA has granted several exclusivities to Auvelity. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Auvelity, 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 Auvelity.
Exclusivity Information
Auvelity holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Auvelity's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 18, 2025 |
Several oppositions have been filed on Auvelity's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Auvelity's generic, the next section provides detailed information on ongoing and past EP oppositions related to Auvelity patents.
Auvelity's Oppositions Filed in EPO
Auvelity has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 31, 2021, by Elkington And Fife Llp. This opposition was filed on patent number EP15861189A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15861189A | May, 2021 | Elkington and Fife LLP | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Auvelity 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 Auvelity's family patents as well as insights into ongoing legal events on those patents.
Auvelity's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Auvelity's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 20, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Auvelity Generics:
There are no approved generic versions for Auvelity as of now.
How can I launch a generic of Auvelity before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Auvelity's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Auvelity's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Auvelity -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 45 mg/105 mg | 22 Dec, 2022 | 1 | 07 Jan, 2040 |
About Auvelity
Auvelity is a drug owned by Axsome Therapeutics Inc. It is used for treating major depressive disorder by administering dextromethorphan and bupropion in combination. Auvelity uses Bupropion Hydrochloride; Dextromethorphan Hydrobromide as an active ingredient. Auvelity was launched by Axsome in 2022.
Can you believe Auvelity received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Auvelity was approved by FDA for market use on 18 August, 2022.
Active Ingredient:
Auvelity uses Bupropion Hydrochloride; Dextromethorphan Hydrobromide as the active ingredient. Check out other Drugs and Companies using Bupropion Hydrochloride; Dextromethorphan Hydrobromide ingredient
Treatment:
Auvelity is used for treating major depressive disorder by administering dextromethorphan and bupropion in combination.
Dosage:
Auvelity is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 105MG;45MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |