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-seven patent family members in forty countries.

There is one drug master file entry for panobinostat lactate.

Summary for PANOBINOSTAT LACTATE

International Patents:	67
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	1
Patent Applications:	58
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	205353-003	Feb 23, 2015		DISCN	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		DISCN	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No			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	205353-002	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015

International Patents for PANOBINOSTAT LACTATE

Country	Patent Number	Title	Estimated Expiration
Chile	2007001689	FORMAS CRISTALINAS SUSTANCIALMENTE PURAS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA; COMPOSICION FARMACEUTICA, UTIL PARA TRATAR UNA ENFERMEDAD QUE RESPONDE A UNA INHIBICION DE LA ACTIVIDAD DE CINASA DE PROT
Eurasian Patent Organization	200802383	ПОЛИМОРФНЫЕ ФОРМЫ N-ГИДРОКСИ-3-[4-[[[2-(2-МЕТИЛ-1H-ИНДОЛ-3-ИЛ)ЭТИЛ]АМИНО]МЕТИЛ]ФЕНИЛ]-2E-2-АКРИЛАМИДА
Honduras	2008001862	POLIMORFOS DE N-HODROXI-3 [4-[[[2-METIL-1H-INDOL-3-IL)ETIL]AMINO] METIL]FENIL]-2E-2-2PROPENAMIDA
Norway	20090135
Ecuador	SP088976	POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA
Nicaragua	200800306	POLIMORFOS DE N-HIDROXI - 3 - [4 - [[[2 - (2-METIL - 1H - INDOL - 3 - IL) ETIL] AMINO] METIL] FENIL] - 2E - 2 - PROPENAMIDA.

Supplementary Protection Certificates for PANOBINOSTAT LACTATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	1590070-7	Sweden		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; 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
1318980	SPC/GB15/085	United Kingdom		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/15/1023 20150901
1912640	PA2016003	Lithuania		PRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980	15C0086	France		PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1318980	C01318980/01	Switzerland		PRODUCT NAME: PANOBINOSTAT; REGISTRATION NO/DATE: SWISSMEDIC 61878 23.12.2015

PANOBINOSTAT LACTATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Panobinostat Lactate

Introduction to Panobinostat Lactate

Panobinostat lactate, marketed under the brand name Farydak by Novartis, is a potent non-selective histone deacetylase (HDAC) inhibitor. It was approved by the FDA on February 23, 2015, for the treatment of multiple myeloma, specifically in combination with bortezomib and dexamethasone in patients who have received at least two prior regimens, including bortezomib and an immunomodulatory agent[1][4].

Approval and Regulatory Status

Panobinostat lactate received accelerated approval from the FDA based on progression-free survival, with ongoing confirmatory trials to demonstrate its clinical efficacy in multiple myeloma treatment. The drug has also been approved in other jurisdictions, including Australia, where it was registered on the Australian Register of Therapeutic Goods (ARTG) on March 31, 2016[4].

Market Positioning

Therapeutic Use

Panobinostat lactate is used in the treatment of multiple myeloma, a type of blood cancer. Its mechanism involves the inhibition of histone deacetylases, which leads to changes in gene expression and protein metabolism. It acts synergistically with bortezomib, enhancing its cytotoxic effects through the simultaneous inhibition of the proteasome and aggresome pathways[4].

Competitive Landscape

The market for multiple myeloma treatments is competitive, with several other drugs and therapies available. However, panobinostat lactate's unique mechanism and synergistic effects with bortezomib position it as a valuable option in the treatment regimen. The drug's approval and inclusion in treatment guidelines have helped it gain a foothold in the market[4].

Financial Performance

Revenue and Sales

Since its approval, panobinostat lactate has generated significant revenue for Novartis. While exact financial figures for Farydak are not publicly disclosed in the sources provided, the drug's inclusion in the treatment protocols for multiple myeloma ensures a steady stream of revenue. The financial performance is influenced by factors such as the number of patients treated, pricing strategies, and market competition.

Pricing and Accessibility

The pricing of panobinostat lactate is a critical factor in its market dynamics. The drug is available in various strengths (10 mg, 15 mg, and 20 mg) and is administered in a specific dosing schedule (20 mg three times a week, with a 2 weeks on/1 week off schedule)[4]. The cost of the drug can be significant, and accessibility is often influenced by healthcare policies and insurance coverage.

Clinical Trials and Development

Ongoing and Future Studies

Panobinostat lactate is being explored in various clinical trials beyond its initial approval for multiple myeloma. For example, it is in Phase 1 trials for the treatment of sickle cell anemia, indicating potential expansion into other therapeutic areas[3].

Collaborations and Partnerships

Novartis, the sponsor of panobinostat lactate, often collaborates with other pharmaceutical companies and research institutions to advance the drug's development and market reach. These collaborations can enhance the drug's financial trajectory by sharing costs and leveraging expertise.

Safety and Toxicology

Nonclinical Findings

Animal studies have shown that panobinostat lactate can cause various toxicities, including thyroid toxicities, hematopoietic and lymphatic system abnormalities, and toxicities in male reproductive organs. These findings are crucial for understanding the drug's safety profile and managing potential side effects in clinical settings[2].

Pharmacovigilance and Risk Management

Post-Marketing Surveillance

Post-marketing surveillance and pharmacovigilance activities are essential for monitoring the safety of panobinostat lactate in real-world settings. Regulatory bodies, such as the FDA and TGA, require ongoing reporting of adverse events to ensure the drug's risk-benefit profile remains favorable[4].

Market Trends and Outlook

Growing Demand for Targeted Therapies

The market for targeted cancer therapies, including HDAC inhibitors like panobinostat lactate, is growing due to their efficacy and specificity. The increasing incidence of cancer, particularly in younger populations, and the need for more effective treatments drive the demand for these therapies[5].

Economic and Public Health Impact

The economic impact of cancer treatments is significant, and drugs like panobinostat lactate contribute to the overall cost of healthcare. However, their effectiveness in improving patient outcomes and quality of life justifies the investment. Public health initiatives and funding for cancer research are crucial for sustaining the development and accessibility of these treatments[5].

Key Takeaways

• Approval and Use: Panobinostat lactate is approved for the treatment of multiple myeloma and is used in combination with bortezomib and dexamethasone.
• Market Position: The drug holds a unique position due to its synergistic effects with bortezomib and its mechanism of action.
• Financial Performance: The drug generates revenue for Novartis, influenced by factors such as patient numbers, pricing, and market competition.
• Clinical Trials: Ongoing trials explore its use in other therapeutic areas, such as sickle cell anemia.
• Safety and Toxicology: The drug has shown various toxicities in animal studies, which are managed through careful clinical monitoring.
• Market Trends: Growing demand for targeted therapies and increasing cancer incidence drive the market for drugs like panobinostat lactate.

FAQs

Q1: What is the primary use of panobinostat lactate?

Panobinostat lactate is primarily used in the treatment of multiple myeloma, specifically in combination with bortezomib and dexamethasone.

Q2: Who is the manufacturer of panobinostat lactate?

Panobinostat lactate is manufactured by Novartis and marketed under the brand name Farydak.

Q3: What are the common side effects of panobinostat lactate?

Common side effects include thyroid toxicities, hematopoietic and lymphatic system abnormalities, and toxicities in male reproductive organs, as observed in animal studies.

Q4: Is panobinostat lactate approved for other conditions besides multiple myeloma?

Currently, panobinostat lactate is approved only for multiple myeloma, but it is being explored in clinical trials for other conditions such as sickle cell anemia.

Q5: How is panobinostat lactate administered?

Panobinostat lactate is administered orally in capsules, with a recommended dose of 20 mg three times a week, following a 2 weeks on/1 week off schedule[4].

Sources

1. DrugBank Online: Panobinostat lactate | DrugBank Online
2. FDA: 205353Orig1s000 | FDA
3. Synapse: Secura Bio, Inc. - Drug pipelines, Patents, Clinical trials - Synapse
4. TGA: Australian Public Assessment Report for Panobinostat lactate
5. Navy Medicine: CANCER PROGRESS REPORT - Navy Medicine