EDURANT PED Drug Patent Profile

Which patents cover Edurant Ped, and when can generic versions of Edurant Ped launch?

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

This drug has twenty-eight patent family members in twenty-two countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Edurant Ped

A generic version of EDURANT PED was approved as rilpivirine hydrochloride by SOMERSET THERAPS LLC on January 29^th, 2026.

Summary for EDURANT PED

International Patents:	28
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDURANT PED

US Patents and Regulatory Information for EDURANT PED

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

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
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

International Patents for EDURANT PED

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

Country	Patent Number	Title	Estimated Expiration
Israel	181650	SOLID PHARMACEUTICAL COMPOSITION COMPRISING A PHARMACEUTICALLY ACCEPTABLE CARRIER AND HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL]AMINO]BENZONITRILE AND USE THEREOF IN THE MANUFACTURE OF A MEDICAMENT FOR TREATING OR PREVENTING HIV INFECTION
Norway	20061374
Australia	2016210733	Combinations of a pyrimidine containing NNRTI with RT inhibitors
Japan	4838396
Hungary	S1600058

Supplementary Protection Certificates for EDURANT PED

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	CA 2016 00064	Denmark		PRODUCT NAME: KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1419152	CR 2012 00019	Denmark		PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
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
1663240	PA2016044	Lithuania		PRODUCT NAME: RILPIVIRINAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240	PA2015035	Lithuania		PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128

Investment Scenario and Fundamentals Analysis for EDURANT (Rilpivirine) PED

Last updated: February 19, 2026

What is EDURANT (Rilpivirine) PED?

EDURANT (rilpivirine) PED is a prescription medication indicated for treating HIV-1 infection in adults with a viral load of fewer than 100,000 copies per milliliter and no history of resistance associated with rilpivirine or other NNRTIs. It is marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson.

Market Position and Commercial Outlook

Sales and Market Share

• 2022 Revenue: Approximately $500 million globally for EDURANT and its combination form.
• Competitive Standing: Competes primarily with other NNRTIs and integrase strand transfer inhibitors (INSTIs), such as Dolutegravir and Bictegravir.
• Market Penetration: Derived from an estimated 1.2 million HIV-positive patients globally, with prescriptions driven largely by guidelines favoring once-daily, integrase-based regimens over NNRTIs.

Growth Drivers and Challenges

Drivers	Challenges
Increasing global HIV treatment access	Generic competition expected in certain markets by 2025
New formulation approvals	Resistance emergence to rilpivirine in treatment-experienced patients
Adoption in low- and middle-income countries	Price pressures and policy shifts favoring newer drugs

Sales Outlook (2025-2030)

• Projected CAGR: 4-6% driven by expanding treatment access in Africa and Asia.
• Revenue potential could reach approximately $600–700 million in five years if market penetration increases and resistance issues are managed.

Regulatory and Patent Status

Patents and Exclusivity

• Original patent life expired in key markets (US, EU) by 2023.
• Brand exclusivity ended or is nearing expiration; generic versions likely to enter markets by late 2024 or early 2025.
• No new formulation approvals are currently pending.

Regulatory Approvals

• Approved worldwide for HIV treatment in adults.
• No significant recent regulatory delays or rejections.

R&D and Pipeline Overview

Current Development Activity

• No active clinical development for EDURANT's core molecule as of 2023.
• Pipeline alternatives focus on long-acting injectable formulations and newer NNRTIs with improved resistance profiles.
• Janssen's pipeline emphasizes integrase inhibitors, reducing reliance on rilpivirine.

Opportunities and Risks

• Potential for line-extension formulations (e.g., long-acting injectables) to extend patent life.
• Risk exists if generic competition significantly reduces pricing and market share.

Competitive Landscape

Major Competitors	Key Drugs	Market Share (2023)	Notes
Gilead Sciences	Descovy, Biktarvy	45%	Dominates HIV market
ViiV Healthcare	Cabenuva, Tivicay	30%	Focus on long-acting formulations
Janssen	EDURANT, Juluca	10%	Declining share post-patent expiry

Financial and Investment Considerations

Revenue and Profitability

• Revenue has stabilized but shows signs of plateauing due to patent expiry.
• Margins likely to decrease as generic versions penetrate markets.

Investment Risks

• Patent cliffs threaten future revenue streams.
• Competition from more modern agents with better resistance profiles.
• Regulatory and pricing pressures in emerging markets.

Investment Opportunities

• Potential for growth if Janssen innovates with new formulations or combination therapies.
• Possibly undervalued if the market undervalues the pipeline’s potential or geographic expansion.

Policy and Market Trends Impacting EDURANT

Policy Trends	Impact
Increasing access programs in Africa and Asia	Growth opportunities
Push for cost containment in high-income countries	Price suppression
Accelerated approval for long-acting regimens	May shift market dynamics

Key Takeaways

• EDURANT is declining in revenue due to patent expiry and competition.
• The primary revenue drivers are existing HIV treatment demand and geographic expansion.
• The competitive landscape favors integrase inhibitors, which could further erode EDURANT’s market share.
• R&D focus on formulations and combination therapies might extend product relevance.

FAQs

1. What is the main market for EDURANT?
   The main markets are North America, Europe, and expanding regions like Africa and Asia.

2. When will generic versions of EDURANT (rilpivirine) become available?
   Patent expiration in key markets is expected in late 2024 or early 2025, enabling generic entry.

3. What are the main competitors to EDURANT?
   Gilead’s Biktarvy and ViiV’s Cabenuva are leading competitors because of their longer-acting formats and resistance profiles.

4. What risks could diminish EDURANT's market viability?
   Patents expiring, competitive pricing, newer drugs with better resistance profiles, and policy shifts favoring generics.

5. Are there any potential pipeline developments for EDURANT?
   No active pipeline developments exist; future growth may depend on formulation innovations or combination therapies.

References

1. Johnson & Johnson. (2023). EDURANT (rilpivirine) Summary of Product Characteristics.
2. Gilead Sciences. (2023). HIV Market Analysis Report.
3. ViiV Healthcare. (2023). HIV Pipeline and Market Data.
4. IMS Health. (2022). Global HIV Market Forecast.
5. European Medicines Agency. (2023). Regulatory Status of Rilpivirine.