PRETOMANID - Generic Drug Details

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

Pretomanid is the generic ingredient in one branded drug marketed by Mylan Ireland Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for PRETOMANID

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	21
Patent Applications:	151
Drug Prices:	Drug price trends for PRETOMANID
What excipients (inactive ingredients) are in PRETOMANID?	PRETOMANID excipients list
DailyMed Link:	PRETOMANID at DailyMed

See drug prices for PRETOMANID

Recent Clinical Trials for PRETOMANID

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
GlaxoSmithKline	Phase 2
Lygature	Phase 2

See all PRETOMANID clinical trials

Pharmacology for PRETOMANID

Drug Class	Antimycobacterial
Mechanism of Action	Organic Anion Transporter 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PRETOMANID

J04AK	Other drugs for treatment of tuberculosis
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for PRETOMANID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Ireland Ltd	PRETOMANID	pretomanid	TABLET;ORAL	212862-001	Aug 14, 2019		RX	Yes	Yes
Mylan Ireland Ltd	PRETOMANID	pretomanid	TABLET;ORAL	212862-001	Aug 14, 2019		RX	Yes	Yes
Mylan Ireland Ltd	PRETOMANID	pretomanid	TABLET;ORAL	212862-001	Aug 14, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for PRETOMANID

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan IRE Healthcare Limited	Dovprela (previously Pretomanid FGK)	pretomanid	EMEA/H/C/005167 Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	yes	2020-07-31

PRETOMANID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pretomanid

Introduction

Pretomanid, a crucial drug in the treatment of multidrug-resistant tuberculosis (MDR-TB), has undergone significant developments in recent years, particularly in terms of market dynamics and financial accessibility. Here, we delve into the key aspects of pretomanid's market and financial trajectory.

Development and Licensing

Pretomanid was developed by the TB Alliance, a not-for-profit organization funded by governments and philanthropic sources. The drug is part of the nitroimidazole class and has been approved by the US Food and Drug Administration (FDA) since 2019. TB Alliance has granted non-exclusive licenses to multiple manufacturers, including Viatris and Mylan, to produce and distribute pretomanid, especially in high-burden, low- and middle-income countries[1][2][5].

Market Situation and Price Reductions

Initially, the cost of pretomanid and the associated treatment regimens, such as BPaLM (bedaquiline, pretomanid, linezolid, and moxifloxacin), was prohibitively high for many countries. However, recent agreements have significantly altered this landscape.

In December 2022, MedAccess, Viatris, and TB Alliance announced a volume guarantee agreement that reduced the price of pretomanid by 34% in over 130 low- and middle-income countries. This reduction brought the overall cost of the BPaLM regimen closer to the cost of previous MDR-TB treatment regimens, making it more accessible to countries with limited budgets[1][2].

Impact of Price Reductions

• Patient Outcomes: By the end of 2023, this price reduction is estimated to have resulted in favorable outcomes for an additional 9,200 patients and avoided 7,900 potential adverse events by switching from the current standard of care[1].
• Financial Savings: The agreement has led to direct savings of $7 million for procurers and is expected to generate further savings for national healthcare budgets[1][2].

Financial Trajectory

Cost Per Treatment Course

The new ceiling price for pretomanid, set at $240 Ex Works per six-month treatment course, has significantly reduced the overall cost of the BPaLM and BPaL regimens. For instance, the BPaLM regimen now costs around $426 per patient course, down from $588, and the BPaL regimen costs approximately $399 per patient course, down from $560[3].

Generic Pricing Estimates

Estimates suggest that generic versions of pretomanid could be produced and sold at a profit for between $0.36 and $1.14 per day, highlighting the potential for further cost reductions through generic manufacturing[5].

Savings and Budget Implications

The reduced prices of pretomanid and other drugs in the regimen, such as bedaquiline, have generated substantial savings. For example, the Global Drug Facility (GDF) estimates that the lower bedaquiline prices will save around $8 million over a 16-month contract period, enough to procure more than 51,000 additional bedaquiline treatments[3].

Market Shaping and Competition

Volume Guarantee and Market Dynamics

The volume guarantee provided by MedAccess to Viatris has not only reduced the price of pretomanid but also set a benchmark for future generic entrants. This agreement increases competition in the TB market, supporting newer entrants and facilitating widespread uptake of highly effective treatments[1][2].

Competitive Pricing

The competitive pricing strategy has led to historic price reductions for other critical DR-TB drugs like bedaquiline. The GDF's new prices for bedaquiline, reduced by up to 55%, have further decreased the overall cost of DR-TB treatment regimens, making them more affordable for low- and middle-income countries[3].

Sustainable Development Goals (SDGs)

The efforts to make pretomanid and associated regimens more affordable align with several Sustainable Development Goals (SDGs), particularly:

• SDG 3: Good Health and Well-being - By increasing access to effective treatments, these initiatives contribute to better health outcomes.
• SDG 10: Reduced Inequalities - Affordable pricing helps reduce health disparities by making treatments accessible to more people, especially in low- and middle-income countries.
• SDG 17: Partnerships for the Goals - The collaborative efforts between MedAccess, Viatris, TB Alliance, and other stakeholders exemplify the power of partnerships in achieving global health goals[1].

Future Projections

Expanded Access

The price reductions and volume guarantee agreements are expected to expand access to pretomanid and associated regimens significantly. By 2023, there was a substantial increase in the number of people treated with the BPaLM regimen, and this trend is anticipated to continue[2].

Generic Manufacturing

The potential for generic manufacturing to further reduce costs is significant. Competitive large-scale generic production could allow for the treatment of 5-10 times more MDR-TB cases within current procurement budgets[4].

Key Takeaways

• Price Reductions: Pretomanid's price has been reduced by 34% in over 130 low- and middle-income countries, making it more affordable.
• Financial Savings: The agreement has generated significant savings for procurers and national healthcare budgets.
• Market Competition: The volume guarantee and competitive pricing have increased market competition, supporting newer entrants and reducing overall treatment costs.
• SDGs Alignment: These efforts align with SDG 3, SDG 10, and SDG 17, contributing to better health outcomes, reduced inequalities, and strong partnerships.

FAQs

What is pretomanid, and how is it used?

Pretomanid is a drug used to treat multidrug-resistant tuberculosis (MDR-TB). It is part of the BPaLM and BPaL treatment regimens recommended by the World Health Organization (WHO).

How has the price of pretomanid been reduced?

The price of pretomanid was reduced by 34% in over 130 low- and middle-income countries through a volume guarantee agreement between MedAccess, Viatris, and TB Alliance.

What are the estimated generic prices for pretomanid?

Generic versions of pretomanid could be produced and sold at a profit for between $0.36 and $1.14 per day.

How do the price reductions impact patient outcomes?

The price reductions have led to favorable outcomes for an additional 9,200 patients and avoided 7,900 potential adverse events by switching from the current standard of care.

What are the financial implications of the price reductions?

The agreements have generated direct savings of $7 million for procurers and are expected to generate further savings for national healthcare budgets.

Sources

1. MedAccess: Treatment for drug-resistant TB - MedAccess
2. MedAccess: Price reduction paves the way for expanded access to highly effective multidrug-resistant tuberculosis treatment
3. Stop TB Partnership: Stop TB's Global Drug Facility Announces Historic Price Reductions for Bedaquiline
4. Oxford Academic: Estimated generic prices for novel treatments for drug-resistant tuberculosis
5. MSF: Promising new tuberculosis drug approved, but will it be affordable?