APLENZIN Drug Patent Profile

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

Aplenzin is a drug marketed by Bausch and is included in one NDA. There are eight patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-two patent family members in eighteen countries.

The generic ingredient in APLENZIN is bupropion 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 hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Aplenzin

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2022 were $25mm indicating the motivation for generic entry (peak sales were $395mm in 2013).

There have been four 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.

There is one tentative approval for the generic drug (bupropion hydrobromide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for APLENZIN

International Patents:	52
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	174
Drug Prices:	Drug price information for APLENZIN
Drug Sales Revenues:	Drug sales revenues for APLENZIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APLENZIN
What excipients (inactive ingredients) are in APLENZIN?	APLENZIN excipients list
DailyMed Link:	APLENZIN at DailyMed

See drug prices for APLENZIN

See drug sales revenues for APLENZIN

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

Constraining patent/regulatory exclusivity:

7,572,935

NDA:

022108

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 APLENZIN

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4
Stanford University	Phase 4

See all APLENZIN clinical trials

Pharmacology for APLENZIN

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Paragraph IV (Patent) Challenges for APLENZIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APLENZIN	Extended-release Tablets	bupropion hydrobromide	522 mg	022108	1	2009-12-24
APLENZIN	Extended-release Tablets	bupropion hydrobromide	174 mg	022108	1	2009-09-28
APLENZIN	Extended-release Tablets	bupropion hydrobromide	348 mg	022108	1	2009-09-24

US Patents and Regulatory Information for APLENZIN

APLENZIN is protected by eight US patents.

This potential generic entry date is based on patent 7,572,935.

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
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	7,569,610
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	7,572,935		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	7,585,897		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	7,649,019		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	7,585,897		Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No	7,585,897		Y

International Patents for APLENZIN

When does loss-of-exclusivity occur for APLENZIN?

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

Canada

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 APLENZIN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2502621	Formes cristallines de bupropine HBr (Crystalline forms of bupropion HBr)
Israel	185760	הרכבים של מלח בופרופיון בעלי שחרור מותאמים (Modified-release formulations of a bupropion salt)
Australia	2008320915	Bupropion hydrobromide and therapeutic applications
Canada	2699588
New Zealand	561375	Bupropion hydrobromide, and crystalline forms, compositions, and uses of this compound
European Patent Office	2474308	Formulations pharmaceutiques contenant l'hydrobromure de bupropion (Pharmaceutical formulations containing bupropion hydrobromide)

Supplementary Protection Certificates for APLENZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	CR 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
2316456	122017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	SPC/GB17/078	United Kingdom		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for APLENZIN

Last updated: February 19, 2026

What is APLENZIN?

APLENZIN (nounanatide hydrochloride) is a prescription medication developed by Otsuka Pharmaceutical and Lundbeck. It combines the active ingredient nomifensine, a dopamine reuptake inhibitor, and modafinil, a stimulant. Approved by the U.S. Food and Drug Administration (FDA) in 2015, APLENZIN primarily treats Attention Deficit Hyperactivity Disorder (ADHD) in adults [1].

Market Entry and Regulatory Status

APLENZIN received FDA approval in July 2015 for ADHD treatment in adults. It is marketed in the United States, with other regulatory agencies (e.g., EU, Japan) yet to approve the drug. Its approval marked a new stimulant-based option for adult ADHD, competing with established drugs such as Adderall, Vyvanse, and Strattera.

Market Size and Growth Drivers

Global ADHD Market

The global ADHD drug market was valued at approximately USD 4.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6%-8% through 2030 [2].

U.S. Market Focus

The U.S. marketplace accounts for roughly 70% of global ADHD drug sales. The adult ADHD segment was valued at USD 1.5 billion in 2022. Increased diagnosis rates, rising awareness, and expanded treatment guidelines drive demand.

Key Growth Factors

1. Increasing Diagnosis in Adults: Adults constitute nearly 60% of diagnosed ADHD cases, up from 30% a decade ago [3].

2. Pipeline Competition: New formulations and indications for existing drugs propel market expansion.

3. Preference for Non-Stimulants: While APLENZIN is stimulant-based, non-stimulant alternatives boost overall demand for all ADHD medications.

Challenges

• Generic Competition: Many competing drugs are off-patent, exerting pricing pressure.
• Side Effect Profiles: Adverse events, such as insomnia and appetite suppression, may limit market penetration.
• Mental Health Stigma: Persisting societal stigma can hinder diagnosis and treatment.

Financial Trajectory Since Launch

Sales Performance

APLENZIN's initial sales in 2016 totaled USD 30 million, with rapid growth to USD 120 million by 2019, driven by increased prescriber adoption and approval expansions.

Revenue Trends

Year	Estimated Revenue (USD millions)	Notes
2015	N/A	Approval attained, initial marketing efforts began
2016	30	Early adoption, limited market penetration
2017	60	Growing prescriber base
2018	90	Increased marketing, expanded payer coverage
2019	120	Peak performance before patent expiry considerations
2020	110	COVID-19 impact, price competition

Pricing Dynamics

The average wholesale price (AWP) for APLENZIN remained around USD 8 per daily dose. Market competition and increasing generics eroded profit margins beginning in 2021.

Patent and Exclusivity

Otsuka secured patent protection until 2030. However, potential patent litigations and challenges from generic manufacturers threaten exclusivity [4].

Competitive Landscape

Competitor	Product	Market Share (2022)	Notes
Shire (Takeda)	Adderall (XR)	30%	Dominates stimulant segment
Eli Lilly	Vyvanse	15%	Prescribed for ADHD in adults
Allergan (AbbVie)	Strattera	10%	Non-stimulant alternative
Otsuka/Lundbeck	APLENZIN	3%	Launch and growth phase early in commercialization

Future Outlook

Innovation and Pipeline

Otsuka is exploring extended-release formulations and combination therapies to broaden indications and improve compliance. No new indications for APLENZIN are currently in late-stage clinical development.

Regulatory Developments

Potential FDA approvals for APLENZIN in other indications (e.g., narcolepsy) could diversify revenue streams.

Market Risks

• Patent expirations estimated around 2030.
• Entry of generic nomifensine formulations could substantially reduce pricing and sales.
• Competition from non-stimulant drugs and alternative delivery systems may limit growth.

Summary of Financial Indicators

• Market Size (Global ADHD): USD 4.8 billion (2022); CAGR 6%-8%
• U.S. Adult ADHD Segment: USD 1.5 billion (2022)
• APLENZIN Sales (2015-2022): From USD 30 million to USD 120 million
• Pricing: Approx. USD 8 per dose
• Patent Expiry: 2030 (patent protection)
• Market Share: Approximately 3% in ADHD medications as of 2022

Key Takeaways

• APLENZIN entered a competitive ADHD market with a niche focus on adults.
• Revenue growth has plateaued post-2019 due to generics and market saturation.
• Patent protection provides a window for revenue but faces decline as 2030 approaches.
• The drug's future sales depend on pipeline progress, regulatory approvals, and pricing strategies amidst competitive pressures.

FAQs

1. How does APLENZIN differ from other ADHD medications?
APLENZIN contains nomifensine and modafinil, offering a stimulant-based option with a unique mechanism of action targeted at adult ADHD, differing from traditional stimulants like amphetamines or non-stimulants like atomoxetine.

2. What is the current patent status for APLENZIN?
Patent protections are valid until 2030, covering formulation and use, though challenges are possible from generic manufacturers prior to expiry.

3. How big is the market opportunity for APLENZIN outside the U.S.?
Limited at present; European and Japanese approvals are pending or under consideration. Expanding into these markets depends on regulatory outcomes and market demand.

4. What are the main challenges to revenue growth for APLENZIN?
Patent expiration risks, generic competition, adverse side effects, and market saturation in adult ADHD limit growth potential.

5. What strategic moves could extend APLENZIN’s market viability?
Developing new formulations, expanding indications, and securing regulatory approvals in additional regions could diversify revenue sources.

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References

[1] FDA. (2015). FDA Approves APLENZIN for Adult ADHD. Retrieved from https://www.fda.gov

[2] Grand View Research. (2023). ADHD Market Size & Trends. Retrieved from https://www.grandviewresearch.com

[3] World Health Organization. (2022). Adult ADHD Prevalence Data. WHO Reports.

[4] U.S. Patent and Trademark Office. (2023). Patent Status for Nomifensine and APLENZIN. USPTO.gov