ANAFRANIL Drug Patent Profile

Which patents cover Anafranil, and what generic alternatives are available?

Anafranil is a drug marketed by Specgx Llc and is included in one NDA.

The generic ingredient in ANAFRANIL is clomipramine hydrochloride. There are eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Anafranil

A generic version of ANAFRANIL was approved as clomipramine hydrochloride by CHARTWELL RX on March 29^th, 1996.

Summary for ANAFRANIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	8
Drug Prices:	Drug price information for ANAFRANIL
What excipients (inactive ingredients) are in ANAFRANIL?	ANAFRANIL excipients list
DailyMed Link:	ANAFRANIL at DailyMed

See drug prices for ANAFRANIL

Recent Clinical Trials for ANAFRANIL

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

Sponsor	Phase
University of California, San Diego	Phase 2
Tirat Carmel Mental Health Center	N/A
Ariel University	N/A

See all ANAFRANIL clinical trials

Pharmacology for ANAFRANIL

Drug Class

Tricyclic Antidepressant

US Patents and Regulatory Information for ANAFRANIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	ANAFRANIL	clomipramine hydrochloride	CAPSULE;ORAL	019906-001	Dec 29, 1989	AB	RX	Yes	Yes
Specgx Llc	ANAFRANIL	clomipramine hydrochloride	CAPSULE;ORAL	019906-002	Dec 29, 1989	AB	RX	Yes	No
Specgx Llc	ANAFRANIL	clomipramine hydrochloride	CAPSULE;ORAL	019906-003	Dec 29, 1989	AB	RX	Yes	No

Anafranil: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Anafranil (clomipramine hydrochloride) is a tricyclic antidepressant (TCA) primarily indicated for the treatment of obsessive-compulsive disorder (OCD). Its market position is characterized by established efficacy in a niche but significant patient population, alongside a mature product lifecycle and competitive pressures from newer drug classes. Financial performance is primarily driven by prescription volume, generic competition, and the pricing strategies of its manufacturers and distributors.

What is Anafranil's Current Market Position?

Anafranil's market position is defined by its long-standing efficacy in treating OCD, particularly for treatment-resistant cases. It is a first-generation antidepressant, specifically a TCA, which differentiates it from newer selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).

Key Market Differentiators:

• Indication Focus: While TCAs have broader antidepressant applications, Anafranil's specific FDA approval for OCD solidifies its position in this therapeutic area. This focused indication limits its overall market breadth compared to drugs with wider approved uses.
• Efficacy Profile: Anafranil has demonstrated robust efficacy in OCD, often considered a potent option for patients who have not responded to SSRIs. This specific strength carves out a critical role in the treatment algorithm.
• Adverse Event Profile: As a TCA, Anafranil carries a more significant side-effect profile compared to SSRIs, including anticholinergic effects (dry mouth, constipation, blurred vision), cardiac effects (orthostatic hypotension, arrhythmias), and central nervous system effects (sedation, confusion). This profile can limit its first-line use and necessitates careful patient selection and monitoring.
• Generic Availability: Anafranil has been available as a generic for many years. This has led to significant price erosion and a highly competitive market landscape driven by cost.

Competitive Landscape:

The primary competition for Anafranil comes from SSRIs and SNRIs, which are generally considered to have more favorable side-effect profiles and are often prescribed as first-line treatments for OCD. Examples include:

• Fluoxetine (Prozac)
• Sertraline (Zoloft)
• Escitalopram (Lexapro)
• Venlafaxine (Effexor XR)

While newer agents like the atypical antipsychotic olanzapine are sometimes used as augmentation therapy in severe OCD, Anafranil remains a standalone pharmacological option in the established treatment paradigm.

How is Anafranil's Financial Performance Tracked?

Anafranil's financial performance is tracked through prescription data, sales revenue reported by manufacturers and distributors, and market share analysis within the OCD treatment segment.

Key Performance Indicators:

• Prescription Volume: The number of prescriptions dispensed annually is a primary indicator of demand. This data is typically sourced from prescription tracking firms. For instance, in the U.S., IMS Health (now IQVIA) data has historically been a key source.
• Sales Revenue: Total revenue generated from Anafranil sales, net of rebates, discounts, and returns. This is reported by the brand holder and generic manufacturers. Specific revenue figures for individual generic drugs are often proprietary and not publicly disclosed unless aggregated by market research firms.
• Market Share: Anafranil's percentage of the total market for OCD treatments, both by volume and value. This is a crucial metric for understanding its competitive standing.
• Average Selling Price (ASP): The average price at which the drug is sold to wholesalers and pharmacies. For generics, this is often influenced by competitive bidding and discounting.
• Wholesale Acquisition Cost (WAC): The list price of a drug before discounts and rebates. While WAC has increased historically for branded drugs, the WAC for generic Anafranil is less indicative of actual transaction prices.

Financial Trajectory Factors:

The financial trajectory of Anafranil is influenced by several factors:

• Generic Competition Intensity: The number of generic manufacturers and the aggressive pricing strategies employed by these companies directly impact revenue.
• Payer Policies: Formulary placement, prior authorization requirements, and step-therapy protocols by insurance companies affect access and prescribing patterns.
• Physician Prescribing Habits: The willingness of psychiatrists and other prescribers to continue using Anafranil, especially for refractory cases, versus opting for newer agents or alternative treatment modalities.
• Patient Adherence and Persistence: The extent to which patients remain on the medication, which is influenced by efficacy and tolerability.
• Incidence and Prevalence of OCD: Changes in the diagnosed population size directly impact the potential market for OCD treatments.

While precise, up-to-date global sales figures for clomipramine hydrochloride are not publicly available due to its generic status and fragmentation across multiple manufacturers, market analysis suggests a stable but modest revenue stream primarily driven by its established role in specific OCD patient subgroups. Its market value is likely in the tens of millions of U.S. dollars annually worldwide.

What are Anafranil's Patent Expirations and Generic Entry Dates?

Anafranil's patent landscape is a critical determinant of its market exclusivity and the subsequent entry of generic competitors. As a well-established drug, its original patents have long expired.

Patent Expirations and Generic Entry:

• Original Compound Patent: The fundamental patent protecting the clomipramine molecule itself expired decades ago. The original patent for clomipramine hydrochloride was filed in the late 1950s and granted in the early 1960s by Ciba (now Novartis).
• Formulation and Method of Use Patents: While primary patents are long gone, secondary patents related to specific formulations (e.g., extended-release versions) or novel methods of use can emerge. However, any such patents for Anafranil are also likely expired or have been successfully challenged by generic manufacturers.
• First Generic Entry: Generic versions of clomipramine hydrochloride entered the market shortly after the expiration of key patents. The exact date of the first generic launch in the U.S. was in the early to mid-1990s. For example, reports indicate generic clomipramine was available by 1993-1994.
• Sustained Generic Competition: Following the initial generic entry, numerous pharmaceutical companies have manufactured and marketed generic clomipramine hydrochloride. This has resulted in a highly fragmented generic market.

The absence of patent protection means Anafranil faces perpetual generic competition, with no possibility of regaining market exclusivity through patent extensions.

How Does Anafranil Compare to Newer OCD Treatments?

Anafranil's comparison to newer treatments highlights its strengths in specific patient populations and its limitations regarding tolerability and convenience.

Comparative Analysis:

Feature	Anafranil (Clomipramine HCl)	SSRIs (e.g., Sertraline, Fluoxetine)	SNRIs (e.g., Venlafaxine XR)
Drug Class	Tricyclic Antidepressant (TCA)	Selective Serotonin Reuptake Inhibitor (SSRI)	Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Primary Indication	Obsessive-Compulsive Disorder (OCD)	Major Depressive Disorder, Anxiety Disorders, OCD (specific SSRIs)	Major Depressive Disorder, Anxiety Disorders, OCD (Venlafaxine XR)
Efficacy in OCD	High efficacy, particularly for severe/refractory cases.	Moderate to high efficacy, often first-line.	Moderate to high efficacy, considered for OCD, especially when comorbid depression is present.
Side Effect Profile	Higher incidence and severity: Anticholinergic (dry mouth, constipation, blurred vision), cardiac (orthostatic hypotension, arrhythmias), CNS (sedation, dizziness, confusion). Potential for overdose toxicity.	Lower incidence/severity: Gastrointestinal (nausea, diarrhea), sexual dysfunction, insomnia/somnolence. Generally better tolerated.	Moderate incidence/severity: Similar to SSRIs, with potential for increased blood pressure and heart rate.
Dosing Frequency	Typically twice daily.	Once daily for most agents.	Once daily (extended-release formulations).
Generic Availability	Yes, multiple manufacturers.	Yes, widely available.	Yes, widely available.
Market Position	Niche for refractory OCD; established but not first-line.	First-line for many anxiety and depressive disorders, including OCD.	Second-line or alternative first-line for depression/anxiety; used for OCD.
Cost	Low (due to generic status).	Low to moderate (generic).	Moderate (generic).

Strengths of Anafranil:

• Potency in Refractory OCD: Its distinct mechanism of action, with significant serotonin reuptake inhibition and some norepinephrine reuptake inhibition, can be effective when SSRIs fail.
• Established Track Record: Decades of clinical experience provide a wealth of data on its efficacy and management of side effects.

Limitations of Anafranil:

• Tolerability: The higher incidence of significant side effects limits its use, particularly in elderly patients or those with cardiovascular comorbidities.
• Safety Margin: The therapeutic index is narrower than SSRIs, making overdose more dangerous.
• Dosing Frequency: Requires more frequent dosing than once-daily SSRIs or SNRIs, potentially impacting adherence.

Newer treatments are generally favored as first-line options due to their more favorable safety and tolerability profiles. Anafranil retains its value as a therapeutic option for a specific subset of patients with severe or treatment-resistant OCD who can tolerate its side effects.

What are the Regulatory Considerations for Anafranil?

Regulatory considerations for Anafranil primarily revolve around its post-marketing surveillance, generic drug approval processes, and labeling requirements.

Key Regulatory Aspects:

• FDA Approval Status: Anafranil (clomipramine hydrochloride) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of obsessive-compulsive disorder. Its initial approval dates back to the late 1980s.
• Generic Drug Approval (ANDA): Generic versions of Anafranil are approved through the Abbreviated New Drug Application (ANDA) pathway. This requires demonstrating bioequivalence to the reference listed drug (RLD), which is typically the branded product (Anafranil). Generic manufacturers must prove their product performs the same as the branded drug in terms of absorption, distribution, metabolism, and excretion.
• Labeling Requirements: Generic drug labels must be essentially the same as the RLD's label, reflecting approved indications, contraindications, warnings, precautions, and adverse reactions. However, differences in inactive ingredients or minor formatting variations are permissible.
• Post-Marketing Surveillance: Like all approved drugs, Anafranil and its generics are subject to post-marketing surveillance. This includes monitoring adverse event reports submitted through the FDA's MedWatch program. Any new safety signals that emerge could lead to labeling updates or, in rare cases, regulatory action.
• Manufacturing Standards: All manufacturers of clomipramine hydrochloride, whether branded or generic, must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, purity, and consistency.
• Controlled Substance Status: Clomipramine hydrochloride is not a controlled substance in the United States.

The regulatory environment for generic drugs is mature and well-established. For Anafranil, the primary regulatory focus is on ensuring continued compliance with cGMP and monitoring for any emerging safety issues through adverse event reporting. There are no active regulatory initiatives suggesting a significant shift in its market status beyond standard post-marketing oversight.

What is the Future Outlook for Anafranil?

The future outlook for Anafranil is one of continued stable demand within its specific therapeutic niche, offset by the persistent realities of generic competition and the availability of newer treatment modalities.

Future Market Dynamics:

• Sustained Niche Demand: Anafranil is expected to maintain its role as a valuable treatment option for a subset of patients with treatment-resistant OCD. This patient population, though not the largest, represents a consistent need that newer drugs may not fully address.
• Impact of Pharmacogenomics: Advances in pharmacogenomics could potentially identify patients who are more likely to respond to clomipramine or experience severe side effects. This could lead to more targeted prescribing, potentially increasing its effectiveness for selected individuals while reducing off-target use.
• Competition from Novel Therapies: Ongoing research into OCD treatments may yield new pharmacological agents, neuromodulation techniques (e.g., transcranial magnetic stimulation), or refined psychotherapeutic approaches. While these may not directly displace Anafranil in its established role, they could further fragment the overall OCD treatment market.
• Pricing Pressures: As a generic drug, Anafranil will continue to face intense pricing pressure from multiple manufacturers. This will limit any significant revenue growth potential.
• Formulation Innovation (Limited): While there might be minor formulation improvements or combinations explored, significant innovation for an established, generic TCA like Anafranil is unlikely to drive substantial market expansion.
• Global Accessibility: In regions with less developed healthcare systems or where newer, more expensive medications are less accessible, Anafranil may continue to be a more widely used and cost-effective option for OCD.

The financial trajectory will likely remain flat to slightly declining in value terms, driven primarily by volume. Any revenue growth would be attributable to increased prescribing in specific resistant populations or geographic markets where it is more prevalent, rather than new indications or significant price increases. The market is mature, and substantial shifts are not anticipated.

Key Takeaways

• Anafranil (clomipramine hydrochloride) is a TCA approved for OCD, valued for its efficacy in treatment-resistant cases.
• Its market position is niche, facing competition from SSRIs and SNRIs with more favorable tolerability profiles.
• Financial performance is characterized by generic competition, leading to price erosion and a stable, modest revenue stream primarily driven by prescription volume.
• Original patents expired decades ago, with generic entry occurring in the early to mid-1990s, ensuring continuous generic competition.
• Anafranil offers potent efficacy but carries a higher risk of side effects compared to newer agents, limiting its first-line use.
• Regulatory oversight focuses on cGMP compliance and post-marketing surveillance for generics.
• The future outlook indicates continued stable demand in its niche, with pricing pressures and competition limiting significant financial growth.

Frequently Asked Questions

1. Is Anafranil still considered a first-line treatment for OCD?

No, Anafranil is generally not considered a first-line treatment for OCD. First-line treatment typically involves SSRIs or SNRIs, which have more favorable side-effect profiles and are better tolerated by most patients. Anafranil is usually reserved for cases where initial treatments have been ineffective.

2. What are the most common serious side effects associated with Anafranil?

Serious side effects associated with Anafranil can include cardiac arrhythmias, significant orthostatic hypotension, seizures, and central nervous system depression. Its anticholinergic effects, such as dry mouth, constipation, and urinary retention, can also be problematic.

3. How does Anafranil's mechanism of action differ from SSRIs?

Anafranil, as a TCA, inhibits the reuptake of both serotonin and norepinephrine into presynaptic neurons. SSRIs, as their name suggests, selectively inhibit the reuptake of serotonin only. This broader action on neurotransmitters contributes to Anafranil's distinct efficacy profile and its side-effect spectrum.

4. Is clomipramine hydrochloride available in extended-release formulations?

Yes, extended-release (ER) formulations of clomipramine hydrochloride are available. These formulations aim to provide more stable plasma concentrations and potentially improve tolerability and dosing convenience compared to immediate-release versions.

5. What is the typical cost of generic clomipramine hydrochloride?

The cost of generic clomipramine hydrochloride is typically low, reflecting the competitive generic market. Prices can vary based on the manufacturer, dosage strength, and the pharmacy or distributor, but it is generally considered a very affordable medication, often costing under $1 per day for many patients.

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Citations

[1] U.S. Food & Drug Administration. (n.d.). Approved Drug Products. Retrieved from [FDA Website] (Specific link not provided as it's a general database)

[2] U.S. Food & Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs) . Retrieved from [FDA Website]

[3] National Institute of Mental Health. (n.d.). Obsessive-Compulsive Disorder. Retrieved from [NIMH Website]

[4] Prescribing information for clomipramine hydrochloride (various manufacturers). (Date of Access). [Accessed via drug databases like DailyMed or manufacturer websites].

[5] Ciba-Geigy Corporation. (1960s). [Original patent filings for clomipramine]. (Specific patent numbers and dates vary and are typically found in patent databases).