BUPROPION HYDROCHLORIDE - Generic Drug Details

What are the generic sources for bupropion hydrochloride and what is the scope of freedom to operate?

Bupropion hydrochloride is the generic ingredient in eight branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Endo Operations, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Prinston Inc, Rising, Sandoz, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Glaxosmithkline, Bausch, Alembic, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, Axsome, and Nalpropion, and is included in sixty-six NDAs. There are one hundred and forty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride has one patent family member in one country.

There are thirty drug master file entries for bupropion hydrochloride. Seventy-seven suppliers are listed for this compound.

Summary for BUPROPION HYDROCHLORIDE

International Patents:	1
US Patents:	143
Tradenames:	8
Applicants:	37
NDAs:	66
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	77
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	381
Patent Applications:	1,767
What excipients (inactive ingredients) are in BUPROPION HYDROCHLORIDE?	BUPROPION HYDROCHLORIDE excipients list
DailyMed Link:	BUPROPION HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUPROPION HYDROCHLORIDE

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

Sponsor	Phase
Currax Pharmaceuticals	Phase 4
Virginia Commonwealth University	Phase 1/Phase 2
Mclean Hospital	Phase 4

See all BUPROPION HYDROCHLORIDE clinical trials

Pharmacology for BUPROPION HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for BUPROPION HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FORFIVO XL	Extended-release Tablets	bupropion hydrochloride	450 mg	022497	1	2013-02-28
WELLBUTRIN XL	Extended-release Tablets	bupropion hydrochloride	150 mg and 300 mg	021515	1	2004-09-21

US Patents and Regulatory Information for BUPROPION HYDROCHLORIDE

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
Invagen Pharms	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	207389-002	Sep 18, 2017		DISCN	No	No
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Aurobindo Pharma Usa	BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090325-002	Apr 8, 2010		DISCN	No	No

Expired US Patents for BUPROPION HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985
Bausch	WELLBUTRIN XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021515-002	Aug 28, 2003
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985

International Patents for BUPROPION HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for BUPROPION HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	2017/059	Ireland		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; REGISTRATION NO/DATE: EU/1/14/988 20150326
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
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

BUPROPION HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bupropion Hydrochloride

Introduction to Bupropion Hydrochloride

Bupropion hydrochloride, an atypical antidepressant, has been a cornerstone in the treatment of major depressive disorder (MDD), seasonal affective disorder (SAD), and as an aid in smoking cessation. Developed in 1966 and initially approved by the FDA in 1985, bupropion has undergone significant transformations, including the development of sustained-release and extended-release formulations, which have enhanced its efficacy and patient compliance[4].

Market Growth Drivers

The market for bupropion hydrochloride extended-release (XL) tablets has experienced substantial growth in recent years, driven by several key factors:

Increasing Prevalence of Mental Health Disorders

The rising incidence of mental health illnesses, particularly among adolescents and young adults, has significantly driven the demand for effective antidepressants. Approximately 1 in 5 adults in the U.S. experiences mental illness each year, with depression being one of the leading causes of disability worldwide[1].

Growing Focus on Efficient Treatment Alternatives

The extended-release formulation of bupropion hydrochloride allows for a once-daily dosage, enhancing patient compliance and reducing adverse effects associated with immediate-release drugs. This formulation provides sustained therapeutic effects and minimizes drug concentration changes, making it a preferred option for clinicians and patients[1].

Regulatory Approvals and Expanding Indications

Regulatory agencies have approved new indications for bupropion hydrochloride, including anxiety disorders and smoking cessation, which has expanded its market potential. These approvals have encouraged pharmaceutical companies to invest in further research and development to broaden the therapeutic applications of bupropion[1].

Financial Trajectory

Market Size and Growth Rate

The global market for bupropion hydrochloride extended-release tablets is projected to exceed several billion dollars in value over the next few years. The market is expected to grow at a compound annual growth rate (CAGR) of approximately 8-10%, fueled by increasing awareness of mental health issues and the corresponding rise in prescriptions for effective antidepressants[1].

Investment and Funding

Investors are recognizing the potential of the bupropion hydrochloride extended-release market, leading to increased funding for research and development. Pharmaceutical companies are investing heavily in clinical trials to further validate the efficacy and safety of bupropion, especially in specific populations such as those with comorbid conditions[1].

Strategic Partnerships and Innovations

Pharmaceutical companies have entered strategic partnerships to enhance research and development efforts in the bupropion market. Collaborations between biotech firms and research institutions are focusing on improving the formulation and delivery of bupropion hydrochloride, including alternative delivery methods such as transdermal patches and subcutaneous injections. These innovations aim to provide consistent medication levels and reduce the risk of relapse in patients with mood disorders[1].

Personalized Medicine and Pharmacogenomics

The trend towards personalized medicine is enhancing the appeal of bupropion hydrochloride extended-release. Clinicians are increasingly using pharmacogenomic testing to tailor antidepressant therapy to individual patient profiles. Bupropion's unique mechanism of action and side effect profile make it an advantageous option for patients who do not respond to traditional SSRIs (Selective Serotonin Reuptake Inhibitors)[1].

Dosage and Administration

The extended-release formulation of bupropion hydrochloride allows for a gradual release of the medication into the bloodstream, providing sustained therapeutic effects. The initial dose is typically 150 mg once daily, which can be increased to 300 mg once daily after 4 days if necessary. For seasonal affective disorder, treatment usually starts in the autumn and continues through winter, with doses adjusted based on the patient's seasonal MDD pattern[3].

Adverse Effects and Safety Considerations

While bupropion hydrochloride is generally well-tolerated, it can have various adverse effects, including hypertension, tachycardia, insomnia, headache, and agitation. Severe adverse effects include a lowered seizure threshold and worsening suicidal ideation. Patients on this medication are typically monitored by a doctor for the duration of treatment[3][4].

Special Patient Populations

For patients with hepatic impairment, the dose of bupropion should be reduced by 50%, with subsequent adjustments based on the balance between therapeutic response and adverse effects. For those with renal impairment, dose adjustments are required, and the maximum recommended dose for patients with an eGFR of 30 to 60 mL/min is 150 mg daily. Older patients also require dose adjustments and renal function monitoring due to the drug's metabolism and excretion profile[3].

Antitrust Litigation and Market Impact

The bupropion hydrochloride market has also been influenced by antitrust litigation. A notable case involved GlaxoSmithKline (GSK) and allegations of reverse payment settlements to delay the entry of generic versions of Wellbutrin XL. The court's decision in favor of GSK highlighted the complexities of antitrust laws and their impact on the pharmaceutical industry[2].

Key Takeaways

• Market Growth: The bupropion hydrochloride extended-release market is growing significantly due to increasing mental health awareness and the need for effective antidepressants.
• Financial Prospects: The market is expected to exceed several billion dollars, growing at a CAGR of 8-10%.
• Innovations: New delivery methods and personalized medicine approaches are enhancing the market's potential.
• Regulatory Momentum: Expanded indications and regulatory approvals are driving market growth.
• Safety and Efficacy: The extended-release formulation offers sustained therapeutic effects with minimized side effects.

Frequently Asked Questions (FAQs)

Q1: What are the primary uses of bupropion hydrochloride? Bupropion hydrochloride is primarily used to treat major depressive disorder (MDD), seasonal affective disorder (SAD), and as an aid in smoking cessation[3][4].

Q2: How does the extended-release formulation of bupropion hydrochloride benefit patients? The extended-release formulation allows for a once-daily dosage, enhancing patient compliance and reducing adverse effects associated with immediate-release drugs. It provides sustained therapeutic effects and minimizes drug concentration changes[1].

Q3: What are the key drivers of the bupropion hydrochloride market growth? The market growth is driven by the increasing prevalence of mental health disorders, growing focus on efficient treatment alternatives, and regulatory approvals expanding its indications[1].

Q4: How does personalized medicine impact the use of bupropion hydrochloride? Personalized medicine, through pharmacogenomic testing, allows clinicians to tailor antidepressant therapy to individual patient profiles, making bupropion an appealing option for those who do not respond to traditional SSRIs[1].

Q5: What are the potential adverse effects of bupropion hydrochloride? Common adverse effects include hypertension, tachycardia, insomnia, headache, and agitation. Severe adverse effects can include a lowered seizure threshold and worsening suicidal ideation[3][4].

Cited Sources

1. Market Research Intellect, "Unlocking Potential: Trends Driving the Bupropion Hydrochloride Extended Release Market," September 27, 2024.
2. Analysis Group, "Wellbutrin XL Antitrust Litigation."
3. StatPearls - NCBI Bookshelf, "Bupropion," September 2, 2024.
4. Britannica, "Bupropion," October 28, 2024.