EDURANT PED Drug Patent Profile

When do Edurant Ped patents expire, and what generic alternatives are available?

Edurant Ped is a drug marketed by Janssen Prods and is included in one NDA. There are two patents protecting this drug.

This drug has two hundred and twenty-six patent family members in forty-six countries.

The generic ingredient in EDURANT PED is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Edurant Ped

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 15, 2027. This may change due to patent challenges or generic licensing.

There have been three 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.

Indicators of Generic Entry

Summary for EDURANT PED

International Patents:	226
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	14
Patent Applications:	560
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDURANT PED
DailyMed Link:	EDURANT PED at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

219016

Dosage:

TABLET, FOR SUSPENSION;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 EDURANT PED

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

Sponsor	Phase
Aptorum International Limited	Phase 1
ViiV Healthcare	Phase 1/Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2

See all EDURANT PED clinical trials

Pharmacology for EDURANT PED

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 EDURANT PED

EDURANT PED is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on NEW PRODUCT.

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
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes			Y	Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes			Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes

Expired US Patents for EDURANT PED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024

International Patents for EDURANT PED

See the table below for patents covering EDURANT PED around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	S1500051
Australia	2011201123	Combinations of a pyrimidine containing NNRTI with RT inhibitors
Eurasian Patent Organization	006656	ПРОИЗВОДНЫЕ ПИРИМИДИНА, ИНГИБИРУЮЩИЕ ВИЧ (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Poland	1632232

Supplementary Protection Certificates for EDURANT PED

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	300850	Netherlands		PRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	132016000024787	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, TENOFOVIR, IN PARTICOLARE TENOFOVIR DISOPROXIL FUMARATO E EMITRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1419152	CA 2012 00019	Denmark
1663240	PA2015037,C1663240-2	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, IR EMTRICITABINODERINYS; REGISTRATION NO/DATE: EU/1/11/737/001 2011-11-28, EU/1/11/737/002 20111128

Market Dynamics and Financial Trajectory for EDURANT PED

Last updated: July 28, 2025

Introduction

EDURANT PED (generic name: rilpivirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), has been a critical component in the management of HIV-1 infections. While primarily marketed to adult populations via branded formulations, its potential inclusion within pediatric (PED) formulations introduces unique market dynamics. Understanding its financial trajectory involves analyzing market factors, regulatory pathways, competitive landscape, and evolving treatment paradigms within HIV therapy.

Market Overview for Rilpivirine (EDURANT PED)

Current Market Position

Rilpivirine entered the HIV treatment landscape with the FDA approval of EDURANT in 2011, targeting combination therapy regimens. Its favorable profiling, including a tolerable side effect profile and minimal drug-drug interactions, positioned it as an alternative to older NNRTIs like efavirenz.

However, its adoption in pediatric populations remains limited. The low prevalence of pediatric HIV cases and the complexity of pediatric formulation development have constrained market penetration thus far. Transitioning EDURANT into PED formulations aims to fill this niche, particularly with growing emphasis on expanding HIV treatments across all age groups.

Pediatric HIV Treatment Landscape

Pediatric HIV management lags behind adult care due to challenges such as drug formulation suitability, adherence issues, and limited clinical trials in children. Major agencies like WHO and UNICEF advocate for age-appropriate formulations, creating a window for pediatric-specific versions of adult antiretrovirals like rilpivirine ([2]).

Regulatory Considerations

The pathway to pediatric approval involves demonstrating safety, efficacy, and appropriate pharmacokinetics in children. The Pediatric Research Equity Act (PREA) and associated guidelines incentivize pharmaceutical companies to pursue pediatric formulations ([3]). Regulatory agencies may condition approval upon conducting dedicated pediatric studies, which influence timelines and R&D costs.

Market Dynamics Influencing EDURANT PED

Demand Drivers

• Global HIV Prevalence in Children: An estimated 1.7 million children under 15 worldwide live with HIV ([4]). Growing access to ART in low- and middle-income countries (LMICs) bolsters demand for pediatric formulations.
• Treatment Guidelines Adoption: WHO’s Universal Treatment Guidelines emphasize early initiation and age-appropriate ART, supporting the inclusion of rilpivirine as a possible candidate for pediatric regimens.
• Patient Adherence: Liquid or dispersible formulations improve adherence in children, making pediatric EDURANT formulations attractive if developed accordingly.

Supply-Side Factors

• Manufacturing Complexity: Producing pediatric formulations (e.g., liquids, dispersibles) entails complex processes, impacting costs.
• Generic Competition: Entry of generics can diminish pricing power but can also expand access, facilitating broader market penetration.
• Patent Lifecycle: The patent status of EDURANT affects market entry strategies. With patent expiry in 2028 in the U.S., generics may enter earlier in some jurisdictions, influencing revenue streams.

Competitive Landscape

• Existing Pediatric Antiretrovirals: Drugs like efavirenz and lopinavir/ritonavir have established pediatric formulations, though toxicity profiles and adherence issues challenge their use.
• Emerging Drugs: Newer agents like cabotegravir or doravirine potentially compete, but rilpivirine’s favorable tolerability benefits maintain its relevance.

Pricing and Reimbursement Dynamics

In high-income countries, payers favor cost-effective regimens with proven safety. Conversely, in LMICs, affordability and access hinge on generic availability, donor funding, and subsidy programs. The pricing strategy for EDURANT PED will notably influence its market uptake, especially in resource-limited settings.

Financial Trajectory: Forecast and Outlook

Revenue Projections

Given the incremental development efforts for pediatric formulations, initial revenue contributions are anticipated to be modest but steadily increasing over time, especially post-approval. Market penetration rates will depend on:

• The speed of regulatory approvals across key markets.
• Adoption by pediatric HIV treatment guidelines.
• Efficacy and safety profiles demonstrated in pediatric trials.
• Competitive pricing in relation to existing therapies.

Cost Considerations

Development costs for pediatric formulations encompass clinical trials, formulation technology (e.g., dispersible tablets), and regulatory process expenses. Although potentially high upfront, these costs are offset by the expected long-term revenue, particularly in LMICs where pediatric HIV cases are concentrated.

Strategic Opportunities and Risks

• Partnerships: Collaborations with global health organizations and generic manufacturers can amplify reach and reduce costs.
• Market Entry Barriers: Regulatory hurdles, formulation challenges, and competition may delay or limit market penetration.
• Patent Expiry and Generics: Approaching patent expiration could threaten early revenues but also open cost-effective generic markets that expand access.

Long-term Financial Outlook

Assuming successful pediatric formulation development and regulatory approval within the next 3-5 years, EDURANT PED could see a compound annual growth rate (CAGR) of 10-15%, driven by expanding global HIV treatment initiatives. In high-income markets, growth may remain moderate, whereas in LMICs, substantial volume-driven increases are plausible, especially with tiered pricing strategies aligned with global health NGO partnerships ([5]).

Conclusion

The financial trajectory of EDURANT PED hinges critically on regulatory success, market acceptance, and competitive positioning within the pediatric ART landscape. While initial revenues are expected to be modest, strategic partnerships and favorable global health policies may unlock significant growth opportunities, especially in the context of increasing pediatric HIV care access worldwide.

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Key Takeaways

• Market Expansion Potential: Pediatric formulations of rilpivirine can fill a significant gap in HIV treatment, especially in LMICs, driven by international health policies.
• Development and Regulatory Challenges: High development costs and complex regulatory pathways pose risks but are mitigated by global demand for age-appropriate HIV medications.
• Competitive Dynamics: Existing pediatric drugs and upcoming alternatives influence market share; positioning rilpivirine as a tolerable and convenient option adds value.
• Pricing and Access Strategy: Tiered pricing, partnerships, and voluntary licensing can optimize market penetration and revenue streams.
• Long-term Outlook: With strategic execution, EDURANT PED could see sustained growth, particularly aligned with ongoing efforts to end pediatric HIV worldwide.

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FAQs

1. What are the primary barriers to introducing EDURANT PED in pediatric markets?
   Challenges include formulating age-appropriate, palatable, and stable formulations; conducting comprehensive pediatric trials; navigating regulatory requirements; and establishing reimbursement pathways.

2. How does patent expiry influence the market potential of EDURANT PED?
   Patent expiration around 2028 may enable generic entrants, reducing prices and expanding access but also risking revenue decline for innovator companies. Strategically timed formulations and licensing can mitigate this impact.

3. What factors could accelerate the adoption of EDURANT PED in global HIV treatment guidelines?
   Demonstrated safety and efficacy in pediatric clinical trials, favorable pharmacokinetic data, and support from WHO and national health agencies can expedite guideline inclusion.

4. Which regions represent the highest growth opportunities for EDURANT PED?
   Sub-Saharan Africa, Southeast Asia, and Latin America, where pediatric HIV prevalence remains high and access to tailored ART formulations is expanding.

5. What role do global health initiatives play in the market success of pediatric HIV drugs like EDURANT PED?
   They facilitate funding, procurement, and distribution, significantly boosting access and market volume in resource-limited settings, thereby enhancing revenue potential.

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References

[1] World Health Organization. (2021). HIV/AIDS Fact Sheet.
[2] UNAIDS. (2022). Global HIV & AIDS statistics.
[3] U.S. Food and Drug Administration. (2020). Pediatric Drug Development Guidance.
[4] UNICEF. (2021). HIV and AIDS in Children: Global Data.
[5] Gilead Sciences. (2023). Corporate Social Responsibility in Global HIV Treatment Access.