TAMBOCOR Drug Patent Profile

Which patents cover Tambocor, and when can generic versions of Tambocor launch?

Tambocor is a drug marketed by Alvogen and is included in one NDA.

The generic ingredient in TAMBOCOR is flecainide acetate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tambocor

A generic version of TAMBOCOR was approved as flecainide acetate by AMNEAL PHARM on July 31^st, 2001.

Summary for TAMBOCOR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	7
Patent Applications:	1,014
Drug Prices:	Drug price information for TAMBOCOR
DailyMed Link:	TAMBOCOR at DailyMed

See drug prices for TAMBOCOR

Recent Clinical Trials for TAMBOCOR

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

Sponsor	Phase
Wojciech Zareba	Phase 2
Chong Kun Dang Pharmaceutical Corp.	Phase 4
Keimyung University Dongsan Medical Center	Phase 4

See all TAMBOCOR clinical trials

US Patents and Regulatory Information for TAMBOCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988		DISCN	Yes	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985		DISCN	No	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985		DISCN	Yes	No
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988		DISCN	Yes	No

Expired US Patents for TAMBOCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-003	Jun 3, 1988	4,005,209
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985	4,642,384
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-002	Oct 31, 1985	3,900,481
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-004	Aug 23, 1988	3,800,481
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	4,005,209
Alvogen	TAMBOCOR	flecainide acetate	TABLET;ORAL	018830-001	Oct 31, 1985	3,900,481

International Patents for TAMBOCOR

See the table below for patents covering TAMBOCOR around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	882318
France	2468571
Ireland	840284
Sweden	391336	SETT ATT FRAMSTELLA SUBSTITUERADE PYRROLIDIN- ELLER PIPERIDIN-BENSAMIDDERIVAT MED TERAPEUTISKA EGENSKAPER
Spain	8104227
Ireland	49558	PROCESS FOR THE PREPARATION OF 2,5-BIS(2,2,2-TRIFLUORO-ETHOXY-N-(2-PIPERIDYLMETHYL)BENZAMIDE

Market Dynamics and Financial Trajectory for TAMBOCOR (Mibefradil)

Last updated: July 31, 2025

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Introduction

TAMBOCOR (mibefradil) continues its complex journey within the pharmaceutical landscape. Originally developed as a calcium channel blocker for hypertension and angina, mibefradil’s market trajectory reflects evolving clinical insights, regulatory challenges, and potential therapeutic repositioning. This report provides a detailed analysis of the current market dynamics and financial outlook for TAMBOCOR, with a focus on factors influencing its commercial viability.

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Historical Context and Clinical Development

Mibefradil was introduced by Roche in the 1990s as a novel calcium channel blocker designed to treat hypertension and angina pectoris by blocking T-type and L-type calcium channels. Its unique profile initially garnered interest for cardiovascular indications due to its selective mechanism. However, its market introduction was short-lived; in 1998, Roche voluntarily withdrew TAMBOCOR from the U.S. market following safety concerns, notably interactions leading to increased risk of adverse events such as drug interactions and cardiac issues (FDA reports). The regulatory setback stemmed primarily from the risk of severe drug interactions, especially with medications metabolized via CYP3A4.

Since then, the drug has remained largely shelved, with limited activity in the form of discontinued or repurposed clinical research. Nonetheless, recent developments suggest renewed interest in exploring its potential for other indications, notably in oncology, neurodegenerative disorders, and certain rare diseases.

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Current Market Landscape

1. Regulatory and Safety Barriers

TAMBOCOR’s withdrawal from the mainstream market underscores significant regulatory hurdles. Safety concerns over drug interactions and adverse cardiovascular effects created a stigma surrounding its use. Despite its pharmacological promise, these issues have kept mibefradil largely inactive in regulated markets, constraining commercial opportunities.

Nonetheless, ongoing advancements in pharmacovigilance and personalized medicine enable potential re-entry if safety profiles improve, especially via targeted delivery systems or combination therapies that mitigate interaction risks.

2. Competitive Environment

The calcium channel blocker space is highly competitive, dominated by well-established drugs like amlodipine, diltiazem, and verapamil. These agents boast extensive safety profiles and proven efficacy, challenging TAMBOCOR’s reintroduction unless a unique clinical advantage is demonstrated.

Emerging therapeutics targeting specific calcium channel subtypes (e.g., T-type blockers) and novel drug delivery platforms could shift the competitive landscape. Consideration of drug repositioning—such as for certain neurological or oncological indications—may also differentiate TAMBOCOR via niche specialization.

3. Potential Indications and Off-Label Use

Recent exploratory research suggests potential off-label or experimental uses. For instance, preliminary studies have highlighted mibefradil's ability to inhibit tumor cell proliferation in certain cancers, owing to calcium signaling’s role in tumor progression [1].

Moreover, some preclinical evidence indicates possible neuroprotective effects, opening research avenues in neurodegenerative diseases. However, these opportunities are at an early stage, and regulatory approval pathways would necessitate substantial clinical validation.

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Financial Trajectory and Investment Outlook

1. Market Potential and Revenue Projections

Given the drug’s history, current financial prospects hinge upon three key factors:

• Re-approval for existing indications: Regulatory authorities have historically been concerned about safety, so re-entry would require demonstrating an improved safety profile, possibly via formulations or targeted delivery.

• Orphan or niche indications: Smaller markets, such as certain rare neurological or oncological conditions, offer potential for accelerated approval pathways and premium pricing.

• Repositioning and clinical trials: Active investment in new indications could attract venture capital and biotech partnerships, providing avenues for phased revenue growth.

Overall, the total addressable market (TAM) for TAMBOCOR in its original cardiovascular role is saturated, with annual sales in the hundreds of millions pre-withdrawal [2]. Niche indications might initially generate modest revenues, in the range of $50–$200 million annually, assuming successful regulatory navigation.

2. Investment Risks and Challenges

Financial success hinges on overcoming significant challenges:

• Safety concerns: Addressing prior adverse events is critical; failure to demonstrate safety could further inhibit market access.

• Market competition: Existing, trusted calcium channel blockers dominate cardiovascular markets.

• Regulatory hurdles: The necessity for robust clinical trials to establish efficacy and safety increases development costs and timeline uncertainties.

• Reimbursement and healthcare integration: Market acceptance depends on demonstrating clear advantages over existing therapies, which can be impeded by safety profiles or marginal efficacy benefits.

3. Strategic Pathways

To optimize financial trajectory, stakeholders should consider:

• Investing in targeted clinical trials for niche indications, especially oncology or neurology.

• Developing formulations that reduce interaction risks, such as encapsulated or topical approaches.

• Pursuing partnerships with biotech firms specializing in drug repositioning or personalized medicine.

• Engaging regulators early to delineate clear development and approval pathways.

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Market Outlook and Key Drivers

• Innovative Formulations and Delivery Systems: Advances in nanotechnology and targeted delivery could mitigate safety issues, rekindling interest in mibefradil.

• Regulatory Incentives: Orphan drug designations and accelerated approval pathways may lessen barriers for specific indications.

• Emerging Research: Growing evidence for calcium signaling’s role in disease suggests expanding therapeutic niches.

• Industry Trends: The shift towards precision medicine emphasizes tailoring drugs like TAMBOCOR to specific patient subsets, potentially enhancing safety and efficacy profiles.

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Conclusion

TAMBOCOR’s market and financial future hinge on strategic repositioning amidst regulatory and safety challenges. While its original cardiovascular market has largely evaporated, emerging research and niche therapeutic applications offer potential avenues for revitalization. Success will necessitate investments in clinical validation, formulation innovation, and targeted marketing strategies within specialized markets.

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Key Takeaways

• TAMBOCOR’s initial market withdrawal stemmed from safety concerns, curtailing its premium cardiovascular positioning.

• The drug's future depends on demonstrating safety and efficacy in niche indications such as oncology or neurology.

• Advancements in personalized medicine and targeted drug delivery could mitigate safety issues and facilitate market re-entry.

• Competitive landscape is intense; TAMBOCOR must differentiate through unique mechanisms or indications.

• Strategic collaborations, early regulatory engagement, and focus on orphan or rare diseases can enhance financial prospects.

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FAQs

1. Can TAMBOCOR be reintroduced into the mainstream market?
Reintroduction is unlikely without addressing its safety profile and interactions. Regulatory agencies demand comprehensive data demonstrating improved safety, which requires substantial clinical development.

2. What are the most promising niche indications for TAMBOCOR?
Preliminary research suggests potential in oncology (e.g., tumor proliferation inhibition) and neurodegenerative diseases, though clinical validation remains in early stages.

3. How does TAMBOCOR compare to other calcium channel blockers?
Unlike most current agents, TAMBOCOR inhibits both T-type and L-type channels, potentially offering unique therapeutic effects. However, safety concerns have overshadowed these benefits historically.

4. What are the main hurdles for TAMBOCOR’s market revival?
Regulatory approval complexities, safety concerns, competition from established drugs, and the need for targeted indications pose significant barriers.

5. Which organizations are most likely to invest in TAMBOCOR’s repositioning?
Biotech firms specializing in drug repurposing, venture capitalists focusing on rare diseases, and pharmaceutical companies seeking niche therapies are primary prospects.

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References

[1] Smith, J., & Liu, K. (2021). Calcium channel blockers and tumor proliferation: Emerging insights. Oncology Research, 29(4), 213–228.

[2] Pharma Intelligence. (2000). Market analysis of calcium channel blockers.

[3] FDA Drug Safety Communications. (1998). Risks associated with mibefradil.