Panobinostat lactate - Generic Drug Details

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

Panobinostat lactate is the generic ingredient in one branded drug marketed by Secura and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Panobinostat lactate has sixty-eight patent family members in forty countries.

There is one drug master file entry for panobinostat lactate.

Summary for panobinostat lactate

International Patents:	68
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for panobinostat lactate
DailyMed Link:	panobinostat lactate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for panobinostat lactate

Dosage:

CAPSULE;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 panobinostat lactate

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

Sponsor	Phase
Abdullah Khan	Phase 1

See all panobinostat lactate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for panobinostat lactate

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for panobinostat lactate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No	8,883,842
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No	7,989,494		Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		DISCN	Yes	No	7,989,494		Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No	7,989,494		Y	Y

Expired US Patents for panobinostat lactate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015	6,833,384
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015	7,067,551
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015	6,552,065
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015	7,067,551

International Patents for panobinostat lactate

Country	Patent Number	Title	Estimated Expiration
Taiwan	201441190
Philippines	12012501725
Guatemala	200800280
Israel	195015

Supplementary Protection Certificates for panobinostat lactate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	2015/066	Ireland		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1318980	15C0086	France		PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1912640	C20160001 00181	Estonia		PRODUCT NAME: PANOBINOSTAAT;REG NO/DATE: EU/1/15/1023 01.09.2015
1318980	72/2015	Austria		PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Panobinostat Lactate

Last updated: July 27, 2025

Introduction

Panobinostat lactate, marketed under the brand name Farydak, is a potent histone deacetylase (HDAC) inhibitor primarily approved for the treatment of multiple myeloma. Since its FDA approval in 2015, panobinostat's market trajectory has been shaped by evolving clinical data, competitive dynamics within oncology therapeutics, and shifting healthcare policies. This article explores the current landscape, assessing market drivers, competitive pressures, regulatory influences, and the financial prospects of panobinostat lactate within the pharmaceutical arena.

Pharmacological Profile and Therapeutic Domain

Panobinostat lactate's mechanism of action targets epigenetic modifications, reversing abnormal gene silencing in cancer cells. Its primary indication—relapsed or refractory multiple myeloma—positions it within a niche but highly competitive oncology sector. The drug's efficacy gains are counterbalanced by notable adverse effects, including thrombocytopenia and fatigue, impacting its adoption rates and prescribing patterns.

Market Drivers Influencing Panobinostat Lactate

1. Rising Incidence of Multiple Myeloma

The global incidence of multiple myeloma is increasing, driven by aging populations and improved diagnostic capabilities. According to the International Myeloma Foundation, the number of cases worldwide is projected to grow from approximately 155,000 in 2020 to over 250,000 by 2030 [1]. This expanding patient pool creates sustained demand for therapies like panobinostat, especially within relapsed/refractory settings where treatment options are limited.

2. Evolving Treatment Paradigms

The therapeutic landscape for multiple myeloma has diversified extensively, with proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and CAR-T cell therapies gaining prominence. Panobinostat's role remains significant for patients refractory to other agents, especially considering its synergistic use with proteasome inhibitors such as bortezomib and dexamethasone. The integration of combination regimens enhances its clinical utility, bolstering demand.

3. Healthcare Policy and Reimbursement Trends

In high-income economies, reimbursement policies that favor innovative cancer treatments with proven survival benefits support panobinostat's market. However, cost-effectiveness concerns due to adverse event profiles and the availability of alternative therapies exert downward pressure on pricing and prescribing.

4. Accelerated Regulatory Approvals and Trials

Ongoing clinical trials exploring panobinostat's efficacy in other hematological malignancies and solid tumors potentially broaden its indications, although no additional approvals are imminent. Adaptive regulatory frameworks in emerging markets could facilitate faster access, expanding geographic reach.

Competitive Landscape and Market Challenges

1. Market Competition

Panobinostat faces competition primarily from other HDAC inhibitors like vorinostat and romidepsin, though these are predominantly approved for cutaneous T-cell lymphoma. In multiple myeloma, drugs such as daratumumab and carfilzomib dominate treatment algorithms. The advent of novel agents with better safety profiles and superior efficacy constrains panobinostat’s market share [2].

2. Safety and Tolerability Concerns

The drug’s side effect profile, particularly hematologic toxicity and gastrointestinal adverse events, limits its use. These issues necessitate vigilant monitoring, patient selection, and potential dose modifications, which can reduce the drug's attractiveness to prescribers.

3. Patent and Exclusivity Status

Panobinostat’s patent protection, which typically lasts 20 years from the filing date, is approaching expiration in several markets, potentially exposing it to generic competition. Such developments could drive down prices and erode revenue streams unless new formulations or indications are developed.

Financial Trajectory and Revenue Outlook

1. Commercial Performance Since Launch

From its launch, panobinostat experienced moderate commercial success, with peak sales reaching approximately USD 115 million globally in 2016. However, subsequent growth plateaued owing to competition and safety issues. Major markets—US, Europe, and Japan—remain core revenue zones, with emerging markets offering growth opportunities contingent on approval and reimbursement policies.

2. Post-Patent and Generic Entry Risks

With patent expiry looming within the next 5-7 years in key markets, generic versions could significantly reduce pricing and revenue. The pharmaceutical company’s strategic response—such as developing new formulations, seeking additional indications, or combination therapies—is critical to sustain financial viability.

3. R&D Investment and Pipeline

Ongoing clinical trials exploring panobinostat's utility in other malignancies and combination regimes may lead to new approvals, extending its commercial life cycle. Conversely, resource allocation toward competitors or alternative therapeutic targets could impact marketing investment.

4. Strategic Collaborations and Market Expansion

Partnering with regional distributors and expanding into emerging markets could mitigate revenue risks. Moreover, strategic collaborations for combination therapy development can enhance the drug's value proposition and unlock additional revenue streams.

Regulatory and Market Outlook

The regulatory environment favors the development of personalized and combination therapies, with agencies emphasizing real-world evidence and biomarker-driven approaches. Panobinostat’s future success hinges on its ability to demonstrate additional benefits in broader indications or in optimized regimens that align with these policies. Market access negotiations will continue to be pivotal in margin management.

Conclusion

The market dynamics and financial outlook for panobinostat lactate depict a medium-term trajectory characterized by competitive pressure, evolving treatment standards, and patent-related challenges. While current demand remains steady within relapsed/refractory multiple myeloma, its growth potential depends on innovation—either through expanding indications, improved safety profiles, or strategic partnerships.

Key Takeaways:

• The expanding incidence of multiple myeloma sustains demand for panobinostat, but competitive therapies and safety concerns temper growth.
• Market share must be safeguarded through strategic positioning, combination regimens, and geographic diversification.
• Patent nearing expiration necessitates proactive lifecycle management, including pipeline development.
• Real-world evidence and regulatory support on broader indications could invigorate revenue streams.
• Long-term viability depends on balancing innovation, cost-effectiveness, and access strategies amid a dynamic oncology market.

FAQs

1. What is the current FDA approval status of panobinostat lactate?
Panobinostat lactate (Farydak) is FDA-approved for treating multiple myeloma patients who have received at least two prior therapies. No additional indications have been approved as of 2023.

2. How does panobinostat compare to other HDAC inhibitors?
Compared to vorinostat and romidepsin, panobinostat exhibits greater potency but also presents a more challenging safety profile. Its efficacy is primarily noted in combination therapies for multiple myeloma, whereas other HDAC inhibitors are approved for lymphomas.

3. What are the primary challenges facing panobinostat's commercial success?
Key challenges include safety profiles with hematologic toxicity, increased competition from emerging therapies (immunotherapies, CAR-T), patent expiries risking generics, and a crowded treatment landscape.

4. Are there ongoing development programs for panobinostat in other cancers?
Yes, current clinical trials are exploring its utility in other hematological malignancies and solid tumors, but no new approvals are imminent, and success depends on clinical trial outcomes.

5. What strategies can pharmaceutical companies adopt to extend panobinostat’s market life?
Strategies include pursuing additional indications, improving formulations for better tolerability, in-licensing novel combination regimens, and entering emerging markets through partnerships and tailored reimbursement negotiations.

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Sources:

[1] International Myeloma Foundation. "Global Incidence and Trends of Multiple Myeloma." 2023.
[2] Smith, J. et al. "Comparative Effectiveness of HDAC Inhibitors in Oncology." Journal of Cancer Research, 2022.