PIFELTRO Drug Patent Profile

When do Pifeltro patents expire, and when can generic versions of Pifeltro launch?

Pifeltro is a drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this drug.

This drug has seventy-five patent family members in forty-five countries.

The generic ingredient in PIFELTRO is doravirine. Two suppliers are listed for this compound. Additional details are available on the doravirine profile page.

DrugPatentWatch^® Generic Entry Outlook for Pifeltro

Pifeltro was eligible for patent challenges on August 30, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PIFELTRO

International Patents:	75
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	4
Drug Prices:	Drug price information for PIFELTRO
What excipients (inactive ingredients) are in PIFELTRO?	PIFELTRO excipients list
DailyMed Link:	PIFELTRO at DailyMed

See drug prices for PIFELTRO

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

Constraining patent/regulatory exclusivity:

8,486,975

NDA:

210806

Dosage:

TABLET;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 PIFELTRO

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

Sponsor	Phase
Chelsea and Westminster NHS Foundation Trust	Phase 3
Merck Sharp & Dohme Corp.	Phase 4
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4

See all PIFELTRO clinical trials

Pharmacology for PIFELTRO

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for PIFELTRO

PIFELTRO is protected by three US patents.

This potential generic entry date is based on patent 8,486,975.

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
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806-001	Aug 30, 2018		RX	Yes	Yes	8,486,975		Y	Y

EU/EMA Drug Approvals for PIFELTRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Pifeltro	doravirine	EMEA/H/C/004747Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.	Authorised	no	no	no	2018-11-22

International Patents for PIFELTRO

When does loss-of-exclusivity occur for PIFELTRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Ukraine

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

See the table below for additional patents covering PIFELTRO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013209405
Spain	2609636
Hungary	S1900022
Mexico	2012011379

Supplementary Protection Certificates for PIFELTRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2552902	C02552902/01	Switzerland		PRODUCT NAME: DORAVIRIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67065 17.12.2019
2552902	LUC00113	Luxembourg		PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1332 20181127
2552902	24/2019	Austria		PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126
2924034	C02924034/01	Switzerland		PRODUCT NAME: DORAVIRIN, LAMIVUDIN UND TENOFOVIRDISOPROXIL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67066 17.12.2019

PIFELTRO (doravirine): Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

PIFELTRO (doravirine) is a once-daily HIV NNRTI positioned primarily in treatment-naïve and switch use cases. Its market dynamics are shaped by (i) competitive pressure from integrase strand transfer inhibitor (INSTI)-dominant regimens, (ii) growth in two-drug and long-acting strategies that reduce reliance on NNRTIs, and (iii) payer-driven preference for fixed-dose combination ecosystems. Financial trajectory data is ultimately determined by net sales under Pfizer’s anti-retroviral portfolio, uptake in guidelines, contract competitiveness, and the timing of generic or biosimilar erosion for relevant jurisdictions.

How has PIFELTRO been positioned in the HIV market?

PIFELTRO is marketed by MSD/Pfizer (Brand name varies by territory) as doravirine in combination with other antiretrovirals. Its clinical narrative emphasizes tolerability and high barrier relative to older NNRTIs, but the commercial battle in HIV has increasingly shifted toward INSTI-led regimens and toward products that consolidate prescriber behavior via fixed-dose combinations.

Key commercial positioning levers

• Once-daily dosing supports adherence and formulary acceptance in chronic therapy.
• Compatibility with common backbone regimens drives switching from older NNRTIs when tolerability and lipid or CNS profiles favor doravirine in prescriber decision-making.
• Formulary fit versus INSTI fixed-dose regimens determines whether clinicians select doravirine-containing regimens for new starts or conversion.

Payer and prescriber dynamics

• Formulary design increasingly favors INSTI-centric pathways, often privileging fixed-dose combinations with preferred tier placement.
• Switch demand is constrained by regimen inertia: patients already stable on alternative therapy typically do not switch absent tolerability, resistance, or interaction needs.

What market forces affect doravirine demand?

Doravirine demand tracks HIV regimen selection patterns rather than pure drug-likeness. The dominant forces are market structure (class share), patient mix, and contracting.

Competitive landscape

• INSTIs are the commercial anchor of modern antiretroviral therapy in most major markets.
• Older NNRTIs face competitive displacement from newer agents, but doravirine still competes with the broader INSTI ecosystem on payer economics and guideline algorithms.

Channel economics

• PBM and national tender behavior can rapidly alter class share even when clinical outcomes are similar across regimens.
• As generic penetration rises for competing anchors (varies by country), payers may re-optimize preferred status, affecting doravirine’s relative share.

Regimen mix and cohort maturity

• Growth in treated populations supports baseline antiretroviral volumes, but incremental share gains require conversion of prescriber behavior, not just patient growth.
• Switching cycles depend on discontinuation rates of comparator regimens, which are typically modest absent side effects or drug-drug interaction triggers.

How does PIFELTRO’s financial trajectory look under these dynamics?

A drug’s financial trajectory in HIV brands typically follows this shape:

1. Launch and initial uptake driven by prescriber education and guideline penetration.
2. Mid-cycle stabilization as formulary wins settle and switching volumes mature.
3. Late-cycle pressure from intensified competition, pricing pressure, and genericization across comparable backbone regimens.
4. Potential rebound if new data or expanded indications unlock additional prescriber segments, or if payers keep a preferred listing.

For PIFELTRO, the late-cycle pressure is the key structural risk: the HIV category continues to move toward INSTI-based fixed-dose and toward long-acting approaches, both of which can reduce incremental NNRTI share.

What are the main drivers of revenue performance for PIFELTRO?

1) Net sales dependence on formulary tiering

• Tier placement and rebate contracts influence patient access.
• Even when clinical outcomes support doravirine, payer preference and PBM contracting often decide volume.

2) Uptake in new starts versus switch

• New-start growth is the most robust path to expansion; it is sensitive to guideline ranking and prescriber default selection.
• Switch volume depends on tolerability or interaction needs and tends to be less elastic.

3) Pricing and discounting

• HIV markets frequently use aggressive discounting and rebate structures.
• Pricing pressure is amplified when competing regimens gain generic or low-cost preferred status in key geographies.

4) Portfolio interactions inside HIV

• Brands that sit alongside other MSD/Pfizer HIV products can be advantaged through cross-portfolio prescribing.
• Conversely, if competitors consolidate regimens in fixed-dose ecosystems, doravirine’s relative role can shrink.

What product and regulatory details matter commercially?

Doravirine label and usage

PIFELTRO is doravirine-based and used as part of combination antiretroviral therapy. In market terms, its commercialization relies on sustained physician acceptance of doravirine-containing combinations.

Regulatory footprint

US prescribing information and global regulatory status underpin payer policy and provider comfort. The core commercial fact pattern rests on doravirine being an established NNRTI in a chronic therapy category. The brand’s ongoing market presence is reflected in continued label use and commercial supply in major markets. (US label source: [1])

How do class-share trends typically translate into PIFELTRO’s earnings path?

The HIV market’s class-share shift is a direct headwind for NNRTI brands. A typical translation into financial outcomes:

• If INSTI dominance increases, doravirine’s share of new starts declines or stays flat.
• If payer contracting shifts toward cheaper INSTI-based combinations, doravirine loses preferred access.
• If switching demand remains steady, doravirine can maintain a stable revenue base, but growth usually slows.

In this structure, PIFELTRO’s trajectory is more likely to resemble stabilization rather than a long growth runway, unless a measurable guideline or payer shift emerges that expands doravirine-containing regimen preference.

Category and product timeline context impacting the financial path

PIFELTRO launched as doravirine expanded into the contemporary NNRTI role in HIV therapy. Its financial trajectory has been shaped by:

• Guideline adoption and prescriber comfort in early and mid periods.
• Competitive intensity from fixed-dose INSTI combinations.
• Potential erosion pressures where comparator backbones and regimen elements move toward generic or lower net cost.

(Clinical label and regulatory details are grounded in the US Prescribing Information. [1])

Market scenario analysis: what should investors assume about directionality?

The following directional assumptions are consistent with HIV commercialization patterns for NNRTI brands:

Base case direction

• Revenue growth slows after early uptake.
• Net sales plateau risk rises as payer preference consolidates around preferred INSTI products.

Downside direction

• Further loss of preferred formulary status in major commercial payers drives share contraction.
• Increased rebate pressure reduces net revenue even if volumes hold.

Upside direction

• Expanded clinical or guideline-driven switching increases steady-state conversion.
• Competitive pricing relief preserves preferred status despite category intensity.

Financial trajectory KPIs investors should track for PIFELTRO (commercial reality metrics)

Even when top-line brand performance appears stable, investors should track:

• Script share by regimen type (new starts vs switch).
• Net price trajectory (rebate compression versus competitor price normalization).
• Formulary penetration (preferred tier reach, prior authorization usage).
• Persistence on therapy (discontinuation rates affect lifetime value).

These KPIs determine whether PIFELTRO remains a durable contributor or becomes a shrinking revenue stream.

Key Takeaways

• PIFELTRO’s market dynamics are dominated by HIV regimen selection that increasingly prioritizes INSTI-led ecosystems, limiting incremental NNRTI share.
• Revenue trajectory is likely to follow a stabilization profile unless payer formularies or guidelines create measurable preference for doravirine-containing regimens.
• Financial performance hinges less on clinical differentiation alone and more on formulary tiering, rebate competitiveness, and the mix between new starts and switches.
• Investors should monitor script share by regimen type and net price/rebate changes because these drive net sales more reliably than broad HIV patient population growth.

FAQs

1. What drug class is PIFELTRO and why does it matter commercially?
   PIFELTRO is doravirine, an NNRTI. Its commercial ceiling is influenced by class-share trends that favor INSTI-based regimens and payer preference for fixed-dose INSTI ecosystems.

2. Does PIFELTRO’s once-daily dosing translate into stronger market performance?
   It supports adherence and formulary acceptance, but it does not override payer contracting and guideline ranking that determine regimen selection in practice.

3. What drives PIFELTRO demand: new starts or switching?
   Both contribute. New-start volume is the key growth driver; switching sustains revenues but typically grows more slowly and is driven by tolerability and interaction triggers.

4. How does generic or pricing pressure affect PIFELTRO’s revenue trajectory?
   It can reduce net revenues via rebate compression and can shift payer preference toward lower-cost preferred regimens, even if patients remain clinically stable.

5. What regulatory information is most relevant to market access?
   The US prescribing information and labeled combination use guide clinician comfort and payer policies tied to indications and regimen compatibility. (Source: [1])

---

References

[1] U.S. Food and Drug Administration. (2024). PIFELTRO (doravirine) prescribing information. https://www.accessdata.fda.gov/