auvelity Drug Patent Profile

When do Auvelity patents expire, and what generic alternatives are available?

Auvelity is a drug marketed by Axsome and is included in one NDA. There are one hundred and thirty patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-eight patent family members in thirty-four countries.

The generic ingredient in AUVELITY is bupropion hydrochloride; dextromethorphan hydrobromide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrochloride; dextromethorphan hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Auvelity

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 20, 2043. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for auvelity

International Patents:	258
US Patents:	130
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for auvelity
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for auvelity
What excipients (inactive ingredients) are in auvelity?	auvelity excipients list
DailyMed Link:	auvelity at DailyMed

See drug prices for auvelity

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for auvelity

Constraining patent/regulatory exclusivity:

12,156,914

NDA:

215430

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for auvelity

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2
Virginia Commonwealth University	Phase 1/Phase 2

See all auvelity clinical trials

Pharmacology for auvelity

Drug Class	Aminoketone Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Paragraph IV (Patent) Challenges for AUVELITY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUVELITY	Extended-release Tablet	bupropion hydrochloride; dextromethorphan hydrobromide	45 mg/105 mg	215430	1	2022-12-22

US Patents and Regulatory Information for auvelity

auvelity is protected by one hundred and thirty US patents.

This potential generic entry date is based on patent 12,156,914.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	10,772,850
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	10,092,560
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	10,894,047
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	9,700,528
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	10,874,664

International Patents for auvelity

When does loss-of-exclusivity occur for auvelity?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

China

European Patent Office

Japan

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering auvelity around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014346807	Compositions and methods comprising bupropion or related compounds and dextromethorphan
Australia	2015350559	Methods of modulating drug plasma levels using erythrohydroxybupropion
Australia	2018203638	COMPOSITIONS AND METHODS COMPRISING BUPROPION OR RELATED COMPOUNDS AND DEXTROMETHORPHAN
Australia	2019201548
Australia	2019223187	Dosage forms and methods for enantiomerically enriched or pure bupropion

Supplementary Protection Certificates for auvelity

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	CA 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
0656775	CR 2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for AUVELITY

Last updated: February 19, 2026

AUVELITY (dextromethorphan + bupropion) received FDA approval in August 2022 for treating major depressive disorder (MDD) in adults. Its market penetration depends on competitive positioning, approval scope, reimbursement landscape, and commercialization strategies.

Market Adoption and Competitive Landscape

Market Size:
Major depressive disorder affects approximately 19 million adults annually in the U.S. (NIMH, 2021). The antidepressant market was valued at around US$15 billion in 2022, projected to grow at 3.2% annually (IQVIA, 2022). AUVELITY enters a dense segment dominated by selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).

Positioning:
AUVELITY is a novel combination of dextromethorphan and bupropion, providing a rapid onset of antidepressant effects compared to traditional therapies. It targets patients with inadequate response to initial antidepressants, aiming for a niche in treatment-resistant depression (TRD). Its unique mechanism offers a potential advantage but faces scrutiny over efficacy and side effect profile.

Competition: Key competitors include esketamine (Spravato), approved for TRD since 2019, and newer oral agents like zuranolone (SAGE-217).	Drug	Approval Year	Indication	Market share (2022)	Key differentiator
AUVELITY	2022	MDD in adults	Emerging	Oral, rapid onset in TRD
Esketamine	2019	TRD, treatment-resistant	2% of antidepressant market	Nasal, rapid-acting
Zuranolone (SAGE-217)	2021	MDD, postpartum depression	Limited	Oral, neuroactive modulator

Pricing and Reimbursement

Pricing: AUVELITY’s wholesale acquisition cost (WAC) is approximately US$850 per month, comparable to esketamine’s $850–$900/month.	Drug	Monthly WAC (USD)
AUVELITY	850
Esketamine	850–900
Zuranolone	800–850

Reimbursement:
Initial coverage relies on Medicare and private insurers. Since AUVELITY is an oral medication, it benefits from easier reimbursement compared to intranasal or IV therapies.
Reimbursement policies depend on formulary inclusion; companies plan to pursue competitive placement to capture market share.

Sales and Revenue Trajectory

Launch Strategy:
Initial launch in the U.S. began post-FDA approval, with focused efforts on specialty care providers and psychiatrists. The company has allocated approximately US$150 million to marketing and education efforts for the first 12 months.

Sales Estimates: Forecasts predict that AUVELITY could reach US$300 million in sales within two years, assuming a 10% adoption rate among estimated 3 million TRD patients (IQVIA).	Year	Revenue Projection	Assumptions
2023	US$50–75 million	Early adoption, limited brand awareness
2024	US$150–200 million	Increased market penetration, expanded prescriber base
2025	US$300–400 million	Uptake accelerates, formulary inclusion improves

Growth Drivers:

• Clinical advantage in rapid symptom relief
• Expanding recognition of treatment-resistant depression
• Increased physician education efforts

Challenges:

• High competition from established oral antidepressants
• Limited long-term efficacy data at this stage
• Reimbursement hurdles and formulary placements

Regulatory and Policy Environment

FDA Status:
Approved for MDD in adults. Awaiting further data on long-term safety and efficacy. No additional indications filed yet.

Potential Expansion:
Regulatory filings underway for pediatric use and bipolar disorder, which could broaden the market scope.

Key Takeaways

• AUVELITY is positioned as a rapid-onset treatment for resistant depression, entering a competitive market with established players.
• Its revenue trajectory depends heavily on market adoption, reimbursement approval, and clinical differentiation.
• Initial sales are projected to be moderate, with growth contingent on formulary acceptance and physician familiarity.
• Competitive advantages include oral delivery and rapid action, but challenges remain from entrenched therapies and safety perceptions.

FAQs

1. How does AUVELITY compare to esketamine in treating TRD?
AUVELITY offers an oral alternative with a rapid onset similar to esketamine but does not require nasal administration or REMS (Risk Evaluation and Mitigation Strategy) program. Its efficacy appears comparable, but long-term data are limited.

2. What pricing strategies are likely to influence market uptake?
Pricing near competitors (around US$850/month) combined with coverage negotiations will impact accessibility. Discounts or value-based rebates may be employed to accelerate formulary inclusion.

3. Are there off-label uses being pursued for AUVELITY?
Current regulatory filings are focused on MDD; off-label use for other psychiatric conditions remains speculative pending further clinical trials.

4. How important is formulary placement for AUVELITY’s success?
Critical. Inclusion in major formularies will significantly influence prescriber adoption and patient access, directly impacting sales growth.

5. What long-term market trends could affect AUVELITY?
Growth in digital health tools and personalized medicine approaches may enhance or pose threats to traditional pharmacologic treatments. Monitoring ongoing clinical trials and post-marketing data will clarify its position.

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References

[1] National Institute of Mental Health. (2021). Major Depression. https://www.nimh.nih.gov/health/statistics/major-depression
[2] IQVIA. (2022). The Global Use of Medicine in 2022.
[3] US Food and Drug Administration. (2022). AUVELITY (dextromethorphan-bupropion) approval announcement.

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