Pralatrexate - Generic Drug Details

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

Pralatrexate is the generic ingredient in one branded drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pralatrexate has thirty-one patent family members in twenty-three countries.

There are two drug master file entries for pralatrexate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for pralatrexate

International Patents:	31
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	39
Patent Applications:	6,567
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pralatrexate
What excipients (inactive ingredients) are in pralatrexate?	pralatrexate excipients list
DailyMed Link:	pralatrexate at DailyMed

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

Dosage:

SOLUTION;INTRAVENOUS

^*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 pralatrexate

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

Sponsor	Phase
Acrotech Biopharma Inc.	Phase 3
Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 1
University of Bologna	Phase 1

See all pralatrexate clinical trials

Generic filers with tentative approvals for PRALATREXATE

Applicant	Application No.	Strength	Dosage Form
		40MG/2ML	INJECTABLE;INJECTION
		20MG/1ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pralatrexate

Drug Class

Folate Analog Metabolic Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for pralatrexate

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PRALATREXATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOLOTYN	Injection	pralatrexate	20 mg/mL and 40 mg/2 mL	022468	4	2013-09-24

US Patents and Regulatory Information for pralatrexate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes

Expired US Patents for pralatrexate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009

EU/EMA Drug Approvals for pralatrexate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Allos Therapeutics Ltd	Folotyn	pralatrexate	EMEA/H/C/002096 treatment of peripheral T-cell lymphoma,	Refused	no	no	yes		2012-06-21

International Patents for pralatrexate

Country	Patent Number	Title	Estimated Expiration
South Korea	20070035490	Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
South Korea	101189693
South Korea	101189692

Pralatrexate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pralatrexate

Introduction to Pralatrexate

Pralatrexate, marketed under the brand name Folotyn, is a small molecule drug that has revolutionized the treatment of various cancers and immune system diseases. Developed by the Memorial Sloan Kettering Cancer Center, it targets dihydrofolate reductase (DHFR), an enzyme crucial for DNA, RNA, and protein synthesis[1].

Regulatory Status and Approvals

Pralatrexate was first approved by the U.S. FDA in September 2009 for the treatment of peripheral T-cell lymphoma (PTCL). It has undergone priority review and accelerated approval processes and has been designated as an orphan drug, indicating its address of a significant unmet medical need[1].

Clinical Indications

Pralatrexate is primarily used in the treatment of various neoplasms, including peripheral T-cell lymphoma, T-cell lymphoma, multiple myeloma, and lymphoma. Its efficacy in these indications has made it a valuable treatment option for patients who may not respond to other therapies[1].

Mechanism of Action

By inhibiting DHFR, pralatrexate disrupts the synthesis of DNA and RNA, thereby inhibiting the growth of cancer cells. This mechanism is particularly effective in preventing the replication of cancer cells, making it a potent tool in cancer treatment[1].

Market Landscape

The market for DHFR inhibitors, including pralatrexate, is highly competitive. As of 2023, there are 43 DHFR drugs worldwide from 71 organizations, covering 96 indications and involving 3122 clinical trials. Pfizer Inc. is a leading player in this market, with several approved drugs targeting DHFR[1].

Economic Evaluation

A cost-utility analysis conducted in Korea based on the PROPEL phase II study showed that pralatrexate is a cost-effective intervention for patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). The incremental cost-effectiveness ratio was $39,153 per quality-adjusted life-year (QALY) gained, which is within the implicit willingness-to-pay threshold for anticancer drugs in Korea[3].

Financial Impact

The financial trajectory of pralatrexate is influenced by several factors, including its cost-effectiveness and the financial burden on patients and healthcare systems. For instance, the cost of pralatrexate treatment includes drug costs, administration, monitoring, and management of adverse events. In the context of R/R PTCL, pralatrexate has shown superior overall survival compared to conventional chemotherapy, which can lead to reduced long-term healthcare costs[3].

Market Forecast

The market forecast for pralatrexate is promising, particularly in the treatment of PTCL. A detailed market assessment by DelveInsight highlights the drug's potential in the United States and Japan, where it is approved for PTCL treatment. The report suggests that the drug's market performance will be driven by its efficacy and the growing demand for targeted therapies in oncology[4].

Risk-Sharing Arrangements

To mitigate the financial uncertainty associated with pralatrexate and other cancer therapies, risk-sharing arrangements (RSAs) can be implemented. These arrangements, such as money-back guarantees or conditional treatment continuation schemes, can reduce costs for payers while ensuring patients receive effective treatments. For example, analyses have shown that RSAs can lead to moderate to significant cost reductions for payers, making pralatrexate more accessible to patients[2].

Global Market Presence

Pralatrexate has been approved for use in global markets, including the United States, and its regulatory status and approvals have facilitated its widespread adoption. The drug's global presence is further supported by ongoing research and development, particularly in regions like China, which is emerging as a key player in DHFR research[1].

Patient Access and Financial Toxicity

Despite its therapeutic benefits, the cost of pralatrexate can impose significant financial burdens on patients. Financial toxicity, a well-recognized adverse impact of cancer treatment, can decrease patients' quality of life and even lead to bankruptcy. Therefore, ensuring affordable access to pralatrexate through various financial assistance programs and risk-sharing arrangements is crucial[5].

Competitive Landscape

The competitive landscape for DHFR inhibitors is intense, with multiple companies focusing on the development of drugs targeting this enzyme. Pfizer Inc. leads in terms of the highest stage of development, and China is emerging as a significant player in this field. This competition drives innovation and potentially lowers costs, making pralatrexate and other DHFR inhibitors more accessible to a broader patient population[1].

Future Development and Innovation

The target DHFR shows promise for future development and innovation in the pharmaceutical industry. With ongoing clinical trials and research, new indications and improved formulations of pralatrexate and other DHFR inhibitors are likely to emerge, further expanding their therapeutic potential[1].

Key Takeaways

• Regulatory Approvals: Pralatrexate has undergone priority review, accelerated approval, and has been designated as an orphan drug.
• Clinical Indications: It is primarily used in treating peripheral T-cell lymphoma, T-cell lymphoma, multiple myeloma, and lymphoma.
• Cost-Effectiveness: Pralatrexate is a cost-effective intervention for R/R PTCL, with an incremental cost-effectiveness ratio within acceptable thresholds.
• Market Forecast: The drug has a promising market forecast, driven by its efficacy and growing demand for targeted therapies.
• Global Presence: Pralatrexate is approved for global use, with ongoing research and development in regions like China.
• Patient Access: Ensuring affordable access through financial assistance programs and risk-sharing arrangements is crucial to mitigate financial toxicity.

FAQs

What is pralatrexate used for?

Pralatrexate is used primarily in the treatment of various neoplasms, including peripheral T-cell lymphoma, T-cell lymphoma, multiple myeloma, and lymphoma.

How does pralatrexate work?

Pralatrexate works by inhibiting the enzyme dihydrofolate reductase (DHFR), disrupting the synthesis of DNA and RNA, and thereby inhibiting the growth of cancer cells.

What is the regulatory status of pralatrexate?

Pralatrexate has undergone priority review, accelerated approval, and has been designated as an orphan drug.

Is pralatrexate cost-effective?

Yes, pralatrexate has been shown to be a cost-effective intervention for patients with relapsed or refractory peripheral T-cell lymphoma, with an incremental cost-effectiveness ratio within acceptable thresholds.

What are the potential side effects of pralatrexate?

Pralatrexate can have side effects as it may also affect normal cells that rely on DHFR activity. Careful monitoring and dosage adjustments are necessary to minimize adverse effects.

Sources

1. Patsnap Synapse: Exploring Pralatrexate's Revolutionary R&D Successes and its Mechanism of Action.
2. CancerIndex: Vinorelbine.
3. PubMed: Cost-utility analysis of pralatrexate for relapsed or refractory peripheral T-cell lymphoma.
4. DelveInsight: FOLOTYN Market Drug Insight.
5. Mayo Clinic Research: Cancer Treatment Clinical Trials.