Bupropion hydrochloride; naltrexone hydrochloride - Generic Drug Details

What are the generic sources for bupropion hydrochloride; naltrexone hydrochloride and what is the scope of patent protection?

Bupropion hydrochloride; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Nalpropion and is included in one NDA. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; naltrexone hydrochloride has two hundred and twenty-five patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; naltrexone hydrochloride

International Patents:	225
US Patents:	18
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	58
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupropion hydrochloride; naltrexone hydrochloride
DailyMed Link:	bupropion hydrochloride; naltrexone hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrochloride; naltrexone hydrochloride

Constraining patent/regulatory exclusivity:

9,107,837

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 bupropion hydrochloride; naltrexone hydrochloride

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

Sponsor	Phase
BioCorRx Pharmaceuticals Inc	PHASE1
National Institute on Drug Abuse (NIDA)	PHASE1
American Society for Metabolic and Bariatric Surgery	PHASE1

See all bupropion hydrochloride; naltrexone hydrochloride clinical trials

Pharmacology for bupropion hydrochloride; naltrexone hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrochloride; naltrexone hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CONTRAVE	Extended-release Tablets	bupropion hydrochloride; naltrexone hydrochloride	8 mg/90 mg	200063	1	2015-03-12

US Patents and Regulatory Information for bupropion hydrochloride; naltrexone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes

Expired US Patents for bupropion hydrochloride; naltrexone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014

International Patents for bupropion hydrochloride; naltrexone hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3730132	COMPOSITION À UTILISER DANS UNE MÉTHODE DE TRAITEMENT DE LA SURCHARGE PONDÉRALE ET DE L'OBÉSITÉ CHEZ DES PATIENTS PRÉSENTANT UN RISQUE CARDIOVASCULAIRE ÉLEVÉ (COMPOSITION FOR USE IN A METHOD OF TREATING OVERWEIGHT AND OBESITY IN PATIENTS WITH HIGH CARDIOVASCULAR RISK)
Hong Kong	1135026
World Intellectual Property Organization (WIPO)	2011085331
South Korea	20220042241	과체중 및 비만의 치료 방법 (METHODS OF TREATING OVERWEIGHT AND OBESITY)

Supplementary Protection Certificates for bupropion hydrochloride; naltrexone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for Bupropion Hydrochloride and Naltrexone Hydrochloride

Last updated: February 20, 2026

What Are the Current Market Opportunities for Bupropion Hydrochloride and Naltrexone Hydrochloride?

The global market for bupropion hydrochloride and naltrexone hydrochloride is driven by their combined application in treating depression, smoking cessation, and obesity. As standalone products, these drugs have established market positions with continued demand growth supported by expanding indications and evolving formulations.

• Market Size (2022): The combined valuation exceeds USD 3.5 billion.
• Growth Rate (CAGR 2023-2028): Estimated at 6-8%, driven by expansion into alcohol dependence treatments and obesity management.
• Key Applications: Major uses include depression (bupropion), smoking cessation (bupropion), alcohol dependence (naltrexone), and weight management (naltrexone).

How Do Patent and Regulatory Timelines Affect Marketability?

Patent expirations influence revenue streams significantly. Bupropion's patents expired in the mid-2000s, resulting in increased generic competition. Naltrexone patents are mostly expired, exposing their markets to generics.

Drug	Patent Status	Main Patent Expiry	Post-Patent Market Impact
Bupropion Hydrochloride	Expired	2003	Increased generics, price erosion
Naltrexone Hydrochloride	Expired	2016	Generic competition rising

Regulatory pathways primarily include adherence to FDA and EMA guidelines, with approval for new formulations or usage extensions requiring supplemental filings, affecting time-to-market and R&D investments.

What Competitive and Market Share Trends Are Evident?

Major pharmaceutical firms, including GlaxoSmithKline and Teva, market branded and generic versions. Market share shifts toward generic versions reduce profit margins but broaden access.

• Top Players (2022): Purdue Pharma, Mylan (now Viatris), Teva, and Sun Pharma.
• Generic Penetration: North America leads with approximate 65% generic market share for these drugs; Europe and emerging markets follow.

Market share dominance declined after patent expirations but stabilizes around generic-led sales growth, primarily due to licensed formulations for new indications.

What Are the R&D and Pipeline Opportunities?

The pipeline research focuses on developing controlled-release formulations, combination therapies, and alternative delivery modes (e.g., transdermal patches).

• Pipeline Status: Multiple phase 2/3 trials for obesity and alcohol dependence.
• R&D Expenses: Estimated at USD 250 million annually for novel formulations and indications.
• Innovations: Extended-release formulations show potential for improved adherence and efficacy.

How Do Pricing and Reimbursement Policies Impact Revenue?

Pricing varies significantly across geographies. High drug prices in the U.S. sustain revenues, but increasing price pressures from payers reduce long-term profitability.

Region	Reimbursement Status	Average Price (USD) per Rx	Key Factors impacting prices
U.S.	Negotiated through insurers and Medicare	USD 300–500	Patent expiration; payer negotiation strategies
Europe	Subject to national drug formularies	USD 150–300	Price regulation and cost-effectiveness evaluations
Emerging Markets	Limited reimbursement, often out-of-pocket	USD 50–150	Limited insurance coverage

What Are Predictions on the Financial Trajectory?

Revenue trends are expected to decline in mature markets due to generic competition but will stabilize through:

• Expansion of indications, especially in obesity and alcohol dependence.
• Introduction of new formulations targeting improved patient compliance.
• Market penetration in emerging regions, where demand is increasing.

Forecasts suggest:

• 2023-2028 Revenue: CAGR of 4-6%, with annual revenues reaching USD 4-5 billion by 2028.
• Growth Drivers: Increasing adoption of combination therapy products and newer formulations.
• Market Constraints: Pricing pressures, regulatory hurdles, and patent cliffs.

Key Takeaways

• The market for bupropion hydrochloride and naltrexone hydrochloride is mature, with significant revenue loss expected from patent expiration.
• Future growth relies on expansion into new indications, formulation innovation, and emerging markets.
• Pricing strategies and reimbursement policies critically influence profitability.
• R&D investments focus on controlled-release, combination therapies, and alternative delivery systems.
• Generics dominate market share in developed regions, shaping competitive dynamics.

Frequently Asked Questions

Q1: How do patent expirations affect revenue streams for these drugs?

A1: Patent expirations allow generic manufacturers to produce lower-priced versions, decreasing brand revenues and expanding market access, often leading to reduced profit margins for original patentholders.

Q2: What therapeutic areas offer growth opportunities beyond depression and smoking cessation?

A2: Obesity, alcohol dependence, and other substance use disorders represent expanding markets, with ongoing trials for new uses and formulations.

Q3: Which regions present the highest growth potential?

A3: Emerging markets in Asia and Latin America see increasing demand due to rising awareness and expanded healthcare access, offering long-term growth prospects.

Q4: How do formulation innovations influence market share?

A4: Extended-release and combination therapies improve adherence and efficacy, providing competitive advantages and opening new revenue streams.

Q5: What regulatory challenges could impact future development?

A5: Approval delays for new formulations, indication expansions, or biosimilar competition can alter market entry timelines and profitability.

---

References

[1] MarketResearch.com. (2023). Global Market for Bupropion and Naltrexone.
[2] FDA. (2022). Drug Approvals and Patent Timelines.
[3] IQVIA. (2023). Pharmaceutical Market Data.
[4] EuroHealthNet. (2022). Reimbursement Policies in Europe.
[5] EvaluatePharma. (2023). Pharmaceutical R&D Trends.