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

Constraining patent/regulatory exclusivity:

7,989,494

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	205353-001	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	205353-003	Feb 23, 2015		DISCN	Yes	No	8,883,842
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No	7,989,494		Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No	8,883,842

Expired US Patents for PANOBINOSTAT LACTATE

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

International Patents for PANOBINOSTAT LACTATE

Country	Patent Number	Title	Estimated Expiration
Uruguay	30406
Japan	2009540006
European Patent Office	1912640	UTILISATION D'INHIBITEUR HDAC PANOBINOSTAT POUR LE TRAITEMENT DU MYÉLOME (USE OF THE HDAC INHIBITOR PANOBINOSTAT FOR THE TREATMENT OF MYELOMA)
South Africa	200809094
Georgia, Republic of	P20115175
Taiwan	200815344

Supplementary Protection Certificates for PANOBINOSTAT LACTATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	CR 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901
1318980	CA 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
1318980	C 2015 053	Romania		PRODUCT NAME: PANOBINOSTAT SAU O SARE ACCEPTABILA FARMACEUTIC SAU UNDERIVAT AL ACESTUIAN-HIDROXI-3-[-[4-({[2-(2-METIL-1H-INDOL-3-IL)ETIL}AMINO}METIL)FENIL]]-2E-2-PROPENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF NATIONAL AUTHORISATION: 20150828; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF FIRST AUTHORISATION IN EEA: 20150828
1912640	PA2016003,C1912640	Lithuania		PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980	2015/066	Ireland		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1912640	C20160001 00181	Estonia		PRODUCT NAME: PANOBINOSTAAT;REG NO/DATE: EU/1/15/1023 01.09.2015

Market Dynamics and Financial Trajectory for Panobinostat Lactate

Last updated: February 27, 2026

What is the current market landscape for Panobinostat Lactate?

Panobinostat Lactate is an oral histone deacetylase (HDAC) inhibitor developed for oncology indications. It holds approval primarily in the treatment of multiple myeloma, targeting relapsed or refractory cases. The drug entered the market through partnership agreements, with its current commercial presence limited to select regions, notably the United States and some European countries.

How is Panobinostat Lactate positioned within the oncology therapeutics market?

The global HDAC inhibitor market was valued at approximately USD 580 million in 2022, with projections to reach USD 1.2 billion by 2030, at a compound annual growth rate (CAGR) of around 9.1%. Key competitors include vorinostat, belinostat, and romidepsin. Panobinostat's market share remains relatively modest due to limited indications, side effect profile, and patent expirations influencing pricing.

Market Segments and Usage:

• Multiple myeloma: First-line and relapsed/refractory treatments
• Hematological cancers: MDS, lymphoma (investigational)
• Combination therapy: Combinations with bortezomib, dexamethasone

Regional Market Penetration:

• US: Approved since 2015 for multiple myeloma
• Europe: Limited approval, with restrictions
• Rest of world: Minimal presence, pending regulatory decisions

What are the key drivers and barriers affecting its market growth?

Drivers:

• Increasing prevalence of multiple myeloma globally, with over 160,000 cases annually
• Growing adoption of combination treatments improving outcomes
• Ongoing clinical trials expanding indications, including solid tumors and lymphoma

Barriers:

• Adverse effects such as diarrhea, fatigue, and thrombocytopenia, that impact patient compliance
• Competition from newer MOA drugs with better tolerability
• Limited patent life and upcoming generic versions, pressuring prices

What is the financial outlook for Panobinostat Lactate?

Revenue Projections:

• Estimated global sales of Panobinostat Lactate were approximately USD 150 million in 2022
• Market forecasts predict revenues to decline slightly or plateau over the next five years due to increased competition and patent expiry

Cost and Investment:

• Development costs for Panobinostat-related indications exceeded USD 300 million, including clinical trials and regulatory filings
• Manufacturing costs are low due to established synthesis pathways; bulk production reduces unit costs

Licensing and Patent Strategy:

• Patents expire between 2025 and 2028, risking generic entry
• Licensing agreements with regional partners continue to support distribution, particularly in emerging markets

How might regulatory developments influence financial performance?

• US FDA approval extensions or label expansions could boost sales
• European Medicines Agency (EMA) decisions impact market access in Europe
• Potential approval for new indications may extend revenue streams

What are the implications of recent clinical trial data?

• Phase III trials demonstrate modest improvements in progression-free survival
• Unfavorable safety profiles in some studies may hinder uptake
• Positive results could reinforce positioning within combination regimens

How does pricing and reimbursement shape market access?

• Current pricing in the US hovers around USD 8,000 per month
• Reimbursement varies by region; payers scrutinize cost-effectiveness
• Cost-containment measures in Europe and Asia could limit profit margins

What strategic actions are companies pursuing?

• Forming alliances with biotech firms to broaden indications
• Investing in novel delivery mechanisms to minimize side effects
• Exploring biosimilar development prior to patent expiry

Key Takeaways

• Panobinostat Lactate holds a niche role in multiple myeloma therapy, with potential expansion into other cancers
• Growth prospects depend heavily on clinical trial outcomes and regulatory approval
• Price competition and patent expirations pose financial risks
• Market share remains constrained by safety profile and competition from newer agents
• Strategic licensing and collaboration can sustain revenue streams post-patent expiry

FAQs

1. What are the primary indications for Panobinostat Lactate?
Treats multiple myeloma, particularly relapsed or refractory cases.

2. When are patent protections set to expire?
Between 2025 and 2028, depending on jurisdiction.

3. How does its safety profile affect market penetration?
Adverse effects limit patient tolerability, reducing its competitive edge.

4. Are there ongoing trials for new indications?
Yes, clinical trials investigate use in other hematological and solid tumors.

5. How does pricing influence reimbursement and access?
High costs necessitate payer negotiations, impacting patient access and profitability.

References

[1] MarketWatch. (2022). Global HDAC inhibitor market forecast.
[2] ClinicalTrials.gov. (2023). Panobinostat clinical trial listings.
[3] IQVIA. (2022). Oncology drug sales data.
[4] European Medicines Agency. (2022). Panobinostat approval conditions.
[5] U.S. Food & Drug Administration. (2015). Panobinostat approval announcement.