Suppliers and packagers for generic pharmaceutical drug: DORAVIRINE

DORAVIRINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806	NDA	Merck Sharp & Dohme LLC	0006-3069-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)	2018-07-20
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806	NDA	A-S Medication Solutions	50090-6268-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-6268-0)	2018-07-20

Suppliers for the Pharmaceutical Drug: DORAVIRINE

Last updated: July 30, 2025

Introduction

Doravirine, marketed under the brand name Pifeltro among others, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) utilized primarily in combination therapies for treating HIV-1 infections. Since its approval by the U.S. Food and Drug Administration (FDA) in 2018, Doravirine has gained prominence for its efficacy, tolerability, and favorable resistance profile. As demand for HIV therapies escalates globally, the supply chain dynamics surrounding Doravirine have become crucial for pharmaceutical companies, healthcare providers, and government agencies. This analysis explores key suppliers, manufacturing players, and supply chain considerations for Doravirine to aid stakeholders in strategic decision-making.

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Manufacturers and Primary Suppliers

1. Merck & Co. Inc.

Merck, the originator of Doravirine, holds the patent rights and is the primary manufacturer of the drug. The company developed Doravirine as part of its broader HIV portfolio and is responsible for its formulation, production, and global distribution, often through licensing agreements with regional partners or generics manufacturers once patent protections expire. Merck's manufacturing facilities for Doravirine are located in the United States and other strategic locations, ensuring supply redundancy and meeting global demand (FDA Drug Approval documents, 2018).

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of novel pharmaceutical synthesis, Merck relies heavily on CMOs for large-scale production. These entities specialize in chemical synthesis, formulation, and quality control processes adhering to Good Manufacturing Practices (GMP). Key CMOs involved in Doravirine production include:

• Cytovance Biologics: Reported to undertake formulating and process optimization activities.

• Patheon (a part of Thermo Fisher Scientific): Engages in large-scale manufacturing and supply chain logistics.

While detailed contract relationships are proprietary, industry sources confirm Merck’s strategic partnerships with CMOs to diversify manufacturing capacity and mitigate supply risks.

3. Regional Licensing and Generic Producers

Although patent protection confers exclusivity, generic manufacturing opportunities are emerging post-patent expiry or through licensing arrangements, particularly in low- and middle-income countries. Major generic producers in regions like India and China are preparing for or have initiated production of Doravirine formulations, contingent upon patent status and licensing agreements with Merck.

• Hetero Labs (India): Reported interest in developing generic NNRTI formulations, including Doravirine, pending patent expiration.

• Cadila Healthcare (India): Announced R&D plans for HIV therapeutics, potentially including Doravirine.

4. Supply Chain Challenges

Despite robust manufacturing capabilities, the supply chain for Doravirine faces challenges such as raw material procurement, complex chemical synthesis routes, and regulatory complexities. Ensuring steady raw material supply—primarily specialized intermediates—is critical. Merck sources raw chemicals from multiple suppliers globally, establishing redundancy to prevent disruptions.

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Key Suppliers of Raw Materials and Intermediates

Doravirine synthesis involves multiple synthetic steps, requiring specialized intermediates and reagents. Prominent suppliers include:

• Sigma-Aldrich (Merck): Provides chemical reagents and intermediates used in synthesis.

• Thermo Fisher Scientific: Supplies starting materials and intermediates for pharmaceutical synthesis.

• Local API (Active Pharmaceutical Ingredient) Suppliers: In regions like India and China, several firms produce generic intermediates that could be utilized in Doravirine manufacturing if patent rights permit.

Ensuring high-quality, GMP-compliant raw materials is critical, with Merck maintaining strict supplier qualification processes.

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Distribution and Geographic Considerations

Merck distributes Doravirine globally through a combination of direct sales and authorized distributors. Major markets include:

• United States: Primary market with extensive supply chain infrastructure.

• Europe: Distributed via licensed partners following EMA approval.

• Asia-Pacific: Growing demand, reliant on regional distributors and potential local manufacturing.

In emerging markets, licensing agreements facilitate local production and reduce reliance on imports, fostering more resilient supply chains.

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Future Outlook: Supply Chain Dynamics

As patents on Doravirine approach expiry, generic manufacturers are anticipated to enter markets, potentially expanding supply sources while impacting pricing and market shares. Merck continues to invest in manufacturing capacity upgrades and quality assurance to prevent shortages. Regulatory agencies are also focusing on supply chain transparency and on ensuring the integrity of the raw materials, especially amid global supply disruptions.

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Concluding Remarks

The supply of Doravirine hinges predominantly on Merck as the patent holder and primary manufacturer, complemented by contract manufacturers and regional licensees. Raw material sourcing, manufacturing capacity, and regulatory compliance determine supply stability. Transitioning into generic markets will diversify supply sources further, potentially reducing costs and increasing access.

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Key Takeaways

• Merck remains the principal supplier for Doravirine, leveraging a combination of internal manufacturing and strategic CMOs.
• Raw material sourcing is complex, with high-quality intermediates vital for production continuity.
• Generic manufacturers in India and China are preparing to enter the market post-patent expiry, expanding supply options.
• Supply chain resilience depends on diversified manufacturing, raw material redundancy, and regulatory compliance.
• Global distribution relies on licensing agreements and local manufacturing in emerging markets.

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FAQs

1. Who are the primary manufacturers of Doravirine?
Merck & Co. Inc. is the exclusive manufacturer of Doravirine, supported by regional licensing and contract manufacturing organizations.

2. Are there generic suppliers for Doravirine?
Currently, generic production is limited but anticipated post-patent expiry, with Indian companies such as Hetero Labs and Cadila Healthcare preparing to develop generic formulations.

3. What raw materials are used in Doravirine manufacturing?
Specialized chemical intermediates and reagents, sourced globally from GMP-compliant suppliers such as Sigma-Aldrich and Thermo Fisher Scientific, are essential.

4. How does patent protection affect supply and competition?
Patent exclusivity limits generic manufacturing, ensuring supply primarily through Merck. Once patents expire, competition increases, diversifying suppliers.

5. What risks threaten Doravirine supply chains?
Raw material shortages, manufacturing disruptions, regulatory hurdles, and patent disputes pose ongoing risks to consistent supply.

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Sources

[1] FDA Drug Approval Data for Doravirine (2018).
[2] Merck Annual Reports and R&D disclosures.
[3] Industry reports on generic HIV drug manufacturing prospects.
[4] Contract manufacturing partnership disclosures from Merck.
[5] Global regulatory agency approvals and licensing agreements.