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Last Updated: December 22, 2024

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FOLOTYN Drug Patent Profile


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Which patents cover Folotyn, and what generic alternatives are available?

Folotyn is a drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.

DrugPatentWatch® Generic Entry Outlook for Folotyn

Folotyn was eligible for patent challenges on September 24, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2025. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (pralatrexate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for FOLOTYN
Drug Prices for FOLOTYN

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOLOTYN
Generic Entry Date for FOLOTYN*:
Constraining patent/regulatory exclusivity:
NDA:
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 FOLOTYN

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

SponsorPhase
Acrotech Biopharma Inc.Phase 3
City of Hope Medical CenterPhase 1/Phase 2
Jennifer AmengualPhase 3

See all FOLOTYN clinical trials

Pharmacology for FOLOTYN
Paragraph IV (Patent) Challenges for FOLOTYN
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 FOLOTYN

FOLOTYN is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FOLOTYN is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

EU/EMA Drug Approvals for FOLOTYN

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FOLOTYN

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

Country Patent Number Title Estimated Expiration
Japan 5271677 ⤷  Subscribe
Japan 2009091361 PURIFIED COMPOSITION OF 10-PROPARGYL-10-DEAZAAMINOPTERIN AND METHOD OF USING THE COMPOUND IN TREATMENT OF TUMOR ⤷  Subscribe
Germany 69738981 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

FOLOTYN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FOLOTYN

Introduction

FOLOTYN, a folate analogue metabolic inhibitor, has been a significant player in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) since its FDA approval in 2009. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key milestones, challenges, and future prospects.

FDA Approval and Initial Market Entry

FOLOTYN, developed by Allos Therapeutics and later managed by Spectrum Pharmaceuticals, received accelerated FDA approval in September 2009 for the treatment of patients with relapsed or refractory PTCL. This approval marked a crucial milestone as FOLOTYN was the first chemotherapy specifically approved for this indication[3].

Sales Performance and Market Reception

Despite the initial excitement, FOLOTYN's sales performance has been somewhat disappointing. In 2011, Allos Therapeutics reported expected FOLOTYN sales of $48-55 million for the year, which was below analyst consensus and the company's own estimates. This soft launch and short duration of therapy contributed to the lower-than-expected sales figures[1].

By 2018, FOLOTYN's net sales had stabilized but still reflected challenges in the market. Spectrum Pharmaceuticals reported $48 million in FOLOTYN sales for the twelve months ended December 31, 2018, which was part of a broader decline in total product sales for the company[2].

Licensing and Partnership Agreements

To bolster its financial position and expand market reach, Allos Therapeutics entered into a significant licensing agreement with Mundipharma International in 2011. This deal provided $50 million upfront and up to $310.5 million in milestones, granting Mundipharma marketing rights outside of the U.S. and Canada. The partnership also included joint funding for development costs, including Phase III studies for new indications[1].

Financial Performance and Operational Costs

Spectrum Pharmaceuticals, which acquired the rights to FOLOTYN, has reported mixed financial results. In the fourth quarter of 2018, FOLOTYN contributed $12.2 million to the company's total product sales of $28 million. However, the company incurred significant research and development expenses ($34.5 million) and selling, general, and administrative expenses ($23.3 million), leading to a net loss of $49.2 million for the quarter[2].

Business Strategy and Market Focus

Spectrum Pharmaceuticals' business strategy for FOLOTYN involves maximizing revenue potential through effective sales and marketing efforts. The company focuses on educating physicians about the drug's safety and efficacy, aiming to achieve maximum commercial success. Additionally, the company explores strategic collaborations and identifies new opportunities to enhance the drug's market presence[3].

Patent and Regulatory Landscape

FOLOTYN is protected by two patents in the U.S. and has thirty-one patent family members in twenty-three countries. The earliest estimated date for generic entry is May 31, 2025, although this could change due to patent challenges or licensing agreements. The drug has faced patent litigation, indicating strong interest from generic manufacturers[4].

Clinical Trials and Indication Expansion

To extend the market life and utility of FOLOTYN, Spectrum Pharmaceuticals and its partners have been conducting various clinical trials. These include Phase III studies for previously undiagnosed PTCL and combination therapy with bexarotene in relapsed or refractory cutaneous T-cell lymphoma. The company is also exploring additional settings where methotrexate, a drug in the same category, has been successfully used[1][3].

Future Prospects and Challenges

The future of FOLOTYN hinges on several factors, including the outcome of ongoing clinical trials, the success of marketing and sales efforts, and the potential impact of generic competition. The drug's unique mechanism of action, which selectively targets cancer cells, offers a competitive edge, but the company must navigate the challenges of a competitive oncology market and evolving regulatory landscapes.

Key Takeaways

  • FDA Approval: FOLOTYN was the first chemotherapy approved for relapsed or refractory PTCL in 2009.
  • Sales Performance: Despite initial expectations, FOLOTYN's sales have been lower than anticipated, with $48 million in sales reported for 2018.
  • Licensing Agreements: Significant partnerships, such as the one with Mundipharma, have provided financial support and expanded market reach.
  • Financial Performance: Spectrum Pharmaceuticals has reported mixed results, with significant operational costs and a net loss in 2018.
  • Business Strategy: The company focuses on maximizing revenue through effective sales and marketing, and exploring new indications and collaborations.
  • Patent Landscape: FOLOTYN is protected by several patents, with the earliest generic entry estimated for May 31, 2025.
  • Clinical Trials: Ongoing trials aim to expand the drug's indications and enhance its market life.

FAQs

What is FOLOTYN used for?

FOLOTYN is used for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Who developed FOLOTYN?

FOLOTYN was developed by Allos Therapeutics and is currently managed by Spectrum Pharmaceuticals.

What was the initial market reception of FOLOTYN?

The initial market reception was disappointing, with sales figures below analyst consensus and the company's own estimates.

What significant licensing agreement did Allos Therapeutics enter into for FOLOTYN?

Allos Therapeutics entered into a licensing agreement with Mundipharma International, providing $50 million upfront and up to $310.5 million in milestones.

When is the earliest estimated date for generic entry of FOLOTYN?

The earliest estimated date for generic entry of FOLOTYN is May 31, 2025.

What are the ongoing clinical trials for FOLOTYN focused on?

The ongoing clinical trials are focused on expanding indications, including previously undiagnosed PTCL and combination therapy with bexarotene in relapsed or refractory cutaneous T-cell lymphoma.

Sources

  1. FierceBiotech: Allos inks $360M Folotyn pact as cancer drug sales disappoint.
  2. BusinessWire: Spectrum Pharmaceuticals Reports Fourth Quarter 2018 and Full-Year 2018 Financial Results and Pipeline Update.
  3. AnnualReports.com: Spectrum Pharmaceuticals Inc - Annual Reports.
  4. DrugPatentWatch: FOLOTYN Drug Patent Profile.

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