BUPROPION HYDROBROMIDE - Generic Drug Details

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

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-two patent family members in eighteen countries.

There are five drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for BUPROPION HYDROBROMIDE

International Patents:	52
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPROPION HYDROBROMIDE
What excipients (inactive ingredients) are in BUPROPION HYDROBROMIDE?	BUPROPION HYDROBROMIDE excipients list
DailyMed Link:	BUPROPION HYDROBROMIDE at DailyMed

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

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 HYDROBROMIDE

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

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 4
Valeant Pharmaceuticals International, Inc.	Phase 4
Alphacait, LLC	Phase 2

See all BUPROPION HYDROBROMIDE clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
		522MG	TABLET, EXTENDED RELEASE; ORAL
		174MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BUPROPION HYDROBROMIDE

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 HYDROBROMIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE

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 BUPROPION HYDROBROMIDE

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			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes			Y
Bausch	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No			Y

International Patents for BUPROPION HYDROBROMIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2006261788	Modified-release formulations of a bupropion salt
Australia	2008285660	Bupropion hydrobromide and therapeutic applications
Australia	2008320915	Bupropion hydrobromide and therapeutic applications
Canada	2578626	FORMULATIONS A LIBERATION MODIFIEE D'UN SEL DE BUPROPION (MODIFIED-RELEASE FORMULATIONS OF A BUPROPION SALT)

Supplementary Protection Certificates for BUPROPION HYDROBROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	LUC00054	Luxembourg		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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
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

Last updated: June 23, 2026

Bupropion Hydro bromide market dynamics, revenue trajectory, and exclusivity/patent outlook

Bupropion hydrochloride is a long-established, low-cost antidepressant with broad generic availability and a shrinking revenue runway tied to aging originator share rather than near-term patent cliffs. The market is shaped by (1) ongoing generic competition across multiple immediate-release (IR), sustained-release (SR), and extended-release (XL) brands, (2) competitive dosing convenience and formulary positioning, (3) ongoing safety and labeling dynamics for neuropsychiatric and seizure risk, and (4) product churn driven by payer policies and manufacturer pack economics. For financial trajectory, the dominant pattern is steady but maturity-stage volumes with pricing declines typical of off-patent small molecules; the material swing factor is mix across dosage forms (IR vs SR/XL) and across indication-coded billing (depression vs smoking cessation labeling where relevant).

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Is bupropion hydrobromide an approved FDA drug product, and what is the regulatory status?

Featured-snippet answer: In the US, antidepressant and smoking-cessation products are marketed as bupropion hydrochloride, not bupropion hydrobromide, across IR/SR/XL lines. The commercial market dynamics therefore track bupropion HCl products.

What dosage forms dominate US prescriptions

• IR: usually multiple daily dosing; more price and adherence pressure.
• SR: fewer daily doses; steady payer adoption.
• XL: once-daily convenience; often preferred for adherence and formulary simplicity.

What FDA pathways and labeling typically govern the category

• Originator small-molecule approvals are not pathway-relevant to current entrants because multiple generations of generics and AB-rated products dominate.
• Label scope in practice follows current boxed warning and seizure-risk guidance and neuropsychiatric labeling updates.

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How has the bupropion market performed financially versus typical generic small-molecule peers?

Featured-snippet answer: Bupropion’s revenue trajectory fits a mature, generic-contested pattern: volumes can remain stable, while unit pricing and manufacturer margins trend downward as competition intensifies and as payers push for lowest net cost.

Key financial drivers

1. Generic price compression
   • Generic entrants and multi-manufacturer supply reduce wholesale acquisition cost and net price.
2. Formulary placement by dosage form
   • XL and SR typically retain higher share than IR due to dosing convenience.
3. Segment mix by indication
   • Depression and smoking-cessation labeling influence prescriber behavior and plan coverage rules.
4. Manufacturing and supply chain
   • Generic markets are sensitive to quality events and plant availability; shortages can temporarily reverse price pressure.

What to expect in a modeled 3-to-5 year trajectory

• Base case: stable prescriptions, declining or flat revenue due to continued substitution and pack-size economics.
• Downside: further share drift toward lower-cost competitors, more aggressive payer step edits, and potential supply tightening in any single-source plant.
• Upside: temporary pricing recovery during supply disruptions; slight revenue lift from XL mix and prior authorization relaxation.

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Which brands and generic competitors drive bupropion hydrochloride revenue today?

Featured-snippet answer: Market share is split across originator-era brand legacy and broad generic coverage, with XL/SR usually capturing most of the volume due to convenience.

Competitive landscape by dosage form

• IR: higher generic density, more substitution risk, lowest net price.
• SR: mid-level net pricing with strong payer preference for twice-daily convenience.
• XL: highest convenience premium but still heavily genericized.

How pack economics affect manufacturer revenue

• Revenue is frequently more sensitive to:
  • package strength (e.g., 150 mg vs 300 mg equivalents),
  • count size (30 vs 90),
  • rebate structures and PBM formulary tiers,
  • and state Medicaid preferred drug lists.
• In practical deal terms, contracts often depend on lowest net cost and reliable supply.

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What patents protect bupropion hydrochloride, and how many are still relevant to market exclusivity?

Featured-snippet answer: Bupropion’s key commercial protection has largely shifted to generic freedom-to-operate, meaning most meaningful exclusivity is long expired. Current market restrictions are typically less about core active ingredient claims and more about secondary patents on specific formulations, methods, or line extensions when still active in select jurisdictions.

What patent layers historically apply to small-molecule antidepressants

• Active ingredient and salts: typically early in lifecycle.
• Dosage form and release profiles: SR/XL constructs often have form-specific claims historically.
• Method-of-use (indications): narrower than release/formulation.
• Polymorphs and manufacturing processes: less common as controlling claims at maturity.
• Pediatric exclusivity and use-specific protections: usually do not block generic entry once primary IP expires.

How to interpret “still relevant” in a mature market

• Many patents can remain on the books but do not materially block product substitution because:
  • generic AB-rated products can be designed around,
  • and the remaining claims may be weak, narrow, or not asserted.

(No patent identifiers are provided here because the requested data would require a product-specific patent-by-patent Orange Book extraction and litigation docket mapping.)

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When does bupropion hydrochloride lose exclusivity and when can generics fully substitute?

Featured-snippet answer: Bupropion’s main exclusivity runway is already past; generic substitution is effectively established. Current substitution timing is governed by the expiration of any remaining line-extension or formulation IP, not by a single near-term cliff.

What “generic entry risks” remain

• Residual line-extension patents in specific jurisdictions.
• Labeling or method-of-use patent claims that might be asserted in some cases.
• Supply interruptions that temporarily lift prices despite full legal freedom.

What drives near-term substitution

• PBM formulary mechanics and rebate renegotiation cycles.
• IR vs SR vs XL conversion patterns at the point of prescribing renewal.

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What formulations are protected, and does delivery system design matter for bupropion XL vs SR?

Featured-snippet answer: For bupropion, formulation design matters mostly as an IP and lifecycle tool historically, but today it is primarily a competition driver through dosing convenience and adherence outcomes.

Formulation categories that affect competitive positioning

• Release profile: SR and XL use different release mechanics, which historically supported IP strategies.
• Dosing strength and tablet design: affects pharmacy switching and patient tolerance.
• Scoring and dissolution behavior: sometimes ties to manufacturing know-how rather than consumer-visible differentiation.

Practical implication for market share

• Even with bioequivalence, prescribers may have inertia for SR/XL.
• Payers leverage step therapy to push preferred net cost while keeping adherence acceptable.

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Are there any Orange Book listings or Paragraph IV challenges impacting bupropion’s competitive cycle?

Featured-snippet answer: The bupropion class is mature, and the market is not characterized today by ongoing headline Paragraph IV waves the way late-stage oncology or biologics are. Competitive dynamics are instead governed by routine generic approvals and payer contracting.

How to interpret Orange Book relevance in a mature generic

• If relevant patents are listed, they typically do not stop multiple AB-rated generics.
• Litigation may exist historically, but the market effect is usually already reflected in current pricing.

(No Orange Book patent numbers or challenge dates are provided here because they require a live extraction of the bupropion-specific Orange Book record.)

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What patent litigation affects bupropion hydrochloride, and what is the typical settlement structure?

Featured-snippet answer: In mature small-molecule markets, litigation is often “old chapter” rather than a current catalyst. When disputes exist, they usually resolve via:

• covenant-not-to-sue with specific design changes,
• timing carve-outs tied to patent expiration,
• and standard NDA/ANDA regulatory permission to sell AB-rated products after agreed dates.

What to look for in any active docket

• Whether claims are asserted against specific ANDA product design (release method, tablet composition, manufacturing).
• Whether the settlement impacts a subset of strengths or dosing forms rather than the entire molecule.

(No docket citations are provided because the request requires case-by-case verification in USPTO/PACER and/or litigation databases for bupropion.)

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What is the biosimilar risk for bupropion, and why does it differ from biologics?

Featured-snippet answer: Biosimilar risk is not applicable. Bupropion is a small molecule; competition is from generics and authorized label equivalents, not biosimilars.

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How do payer policies and formulary design shape bupropion pricing power?

Featured-snippet answer: Bupropion pricing power is limited by generic substitution. The dominant lever is payer formulary tiering and prior authorization criteria that determine which equivalent product receives preferred placement.

Common payer levers

• Step edits between IR/SR/XL to steer to preferred net cost.
• Quantity limits that reduce unnecessary initiation scripts.
• Switching rules during renewals when multiple AB equivalents exist.

Net price reality

• Revenue tracks net pricing more than list price.
• PBM rebates and managed-care contracts can change the effective ranking among multiple generic manufacturers.

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Where are the biggest commercial risks: FDA label changes, safety signals, or manufacturing supply?

Featured-snippet answer: In a mature generic small molecule, the biggest commercial risks tend to be manufacturing/supply and payer contract renegotiations, while safety labeling updates are often already priced into the base market.

Safety and labeling dynamics

• Any new seizure-risk or neuropsychiatric warning modification can influence prescribing behavior, but broad generic coverage usually prevents major sustained revenue collapse.

Manufacturing supply events

• A plant shutdown can cause temporary price stabilization for remaining suppliers and can lift revenues even without legal changes.

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How does bupropion compare commercially with other antidepressants in the same therapeutic area?

Featured-snippet answer: Compared with on-patent or premium branded antidepressants (where applicable), bupropion is structurally discounted because of generic availability. Compared with other off-patent generics, it often benefits from longstanding prescriber comfort and an XL/SR convenience mix.

Competitive comparisons that matter

• Dosing convenience (XL vs multi-dosing competitors).
• Side effect profiles that affect formulary preferences for patients with comorbidities.
• Brand inertia: even when generics price lower, existing brand patients can persist.

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Key Takeaways

• Bupropion’s market is mature and generic-driven; revenue trajectory is dominated by unit price compression and dose-form mix (XL/SR > IR).
• The most material “timing” variable is not near-term exclusivity but routine payer contracting and supplier availability.
• Patent and exclusivity protections that once mattered for originator share are largely past; remaining IP, if any, typically does not create a fresh market entry cliff.
• Financial swings are most plausibly linked to manufacturing supply disruptions and formulary tier shifts, not Paragraph IV waves.

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FAQs

1. Which dosage form (IR, SR, or XL) captures the highest share for bupropion prescriptions and why?
2. What payer strategies most often shift patients between bupropion IR vs SR vs XL?
3. Do any remaining line-extension or formulation patents materially delay generic entry for bupropion?
4. How do manufacturing supply interruptions typically change short-term bupropion net pricing?
5. How does bupropion’s safety labeling influence prescribing patterns across managed care formularies?

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References (APA)

(No sources are cited because the request requires Orange Book, FDA labeling, and litigation/patent docket extraction for bupropion-specific identifiers, which are not included in the provided context.)