EDURANT Drug Patent Profile

Which patents cover Edurant, and what generic alternatives are available?

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

The generic ingredient in EDURANT 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

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

Summary for EDURANT

US Patents:	0
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDURANT

US Patents and Regulatory Information for EDURANT

EDURANT is protected by zero 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	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	AB	RX	Yes	Yes
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	AB	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

International Patents for EDURANT

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

Country	Patent Number	Title	Estimated Expiration
Austria	472537
Australia	2001233979
Australia	3397901
Brazil	0108879
Brazil	122014024864	derivado de pirimidina, processo para preparar um derivado de pirimidina, composição farmacêutica, e, uso de um derivado de pirimidina

Supplementary Protection Certificates for EDURANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	12C0035	France		PRODUCT NAME: RILPIVIRINE AINSI QUE SES FORMES THERAPEUTIQUEMENT PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION DE RILPIVIRINE PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1663240	CA 2015 00054	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ETN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMACEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, OG EMTRICITABIN; REG. NO/DATE: EU/1/11/737/001-002 20111128
1419152	C 2012 015	Romania		PRODUCT NAME: RILPIVIRINA SI TOATE FORMELE ECHIVALENTE TERAPEUTIC ALEACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA RILPIVIRINEI CU ACIDULCLORHIDRIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/736/001; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/736/001; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1663240	CA 2016 00063	Denmark		PRODUCT NAME: RILPIVIRIN ELLER TERAPEUTISK AEKVIVALENT FORM DERAF BESKYTTET AF GRUNDPATENTET SASOM ET FARMACEUTISK ACCEPTABELT SALT FX HYDROCHLORIDSALTET AF RILPIVIRIN OG TENOFOVIRALAFENAMID ELLER FARMACEUTISK ACCEPTABELT SALT DERAF FX TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1663240	132016000129162	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623

Investment Scenario and Fundamentals Analysis of Edurant (Rilpivirine)

Last updated: February 20, 2026

What is Edurant’s (Rilpivirine) market position?

Edurant (rilpivirine) is an antiretroviral medication approved for the treatment of HIV-1 infection. Developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, it belongs to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs). Launched in 2011, Edurant was positioned as a potent, once-daily oral option with a favorable side effect profile, targeting treatment-naive adults.

Its market share is embedded within the larger HIV treatment landscape. As of 2022, the global HIV therapeutic market was valued at approximately USD 22 billion, with NNRTIs holding around 20-25%. Rilpivirine's sales accounted for roughly 7-8% of that segment, driven by its efficacy and tolerability profile.

What are the key fundamentals influencing Edurant’s valuation?

Patent and Regulatory Status

• Patent Life: Edurant’s primary patents expired in the U.S. in 2023, with secondary patents and formulation protections extending to 2025-2026 in certain jurisdictions, limiting generic competition initially.
• Regulatory approvals: Approved in numerous markets, including the U.S., EU, and Japan. Ongoing global approvals expand revenue potential.

Revenue and Sales Trends

• Historical sales: Peak annual sales reached USD 400 million in the late 2010s. In 2022, sales declined to approximately USD 250 million, influenced by generic competition and market saturation.
• Market share: It holds a niche position among first-line treatments, competing with drugs like bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) and dolutegravir-based regimens.

Competitive Landscape

• Generic Competition: Post-patent expiry, generic rilpivirine products entered several markets, compressing sales margins.
• New Therapies: Advances in HIV treatment focus on integrase inhibitors (e.g., Biktarvy, Tivicay) with superior efficacy, tolerability, and higher barriers to resistance, reducing Edurant's market share.

R&D Pipeline and Lifecycle Management

• Formulations: Limited innovation; no approved long-acting or injectable formulations.
• Pipeline: No major pipeline candidates announced for rilpivirine; focus is on next-generation antiretrovirals.

Cost and Profitability

• Manufacturing costs: Relatively low due to established synthesis routes.
• Profit margins: Decline in sales negatively impacts margins; generic competition further compresses profitability.

Geographic Exposure

• Developed Markets: U.S., Europe, Japan constitute ~70% of sales.
• Emerging Markets: Less penetrated, presenting growth potential but affected by pricing pressures.

What are the investment risks and opportunities?

Risks

• Patent expiration: Severely limits pricing power outside of jurisdictions with extended patent protections.
• Market saturation: Growth prospects constrained in mature markets.
• Competitive threats: Dominance of integrase inhibitors and potential new drug entrants diminish unit sales.
• Pricing pressure: Healthcare policies favor generics and cost containment.

Opportunities

• Long-acting formulations: Absence of rilpivirine in long-acting settings limits competitive edge; potential entrants could convert its utility.
• Market expansion: Increasing HIV prevalence in Asia and Africa could provide incremental sales, contingent on pricing and approval.
• Brand loyalty: Few fixed-dose combinations include rilpivirine, allowing potential niche positioning.

Financial outlook and strategic implications

• Revenue trajectory: Likely to decline in the coming years without new formulations or indications.
• Investment profile: Suitable for investors seeking exposure to the HIV treatment space with high certainty of sales decline but stable cash flows in the short term.
• Partner and licensing dynamics: Janssen's focus on pipeline drugs reduces emphasis on rilpivirine, potentially affecting future marketing.

Summary analysis table

Parameter	Current Status	Outlook
Patent expiries	2023 (U.S.), 2025 (EU, Japan)	Increased generic competition
Sales (2022)	USD 250 million	Declining trend
Market share	~7-8% in HIV NNRTI segment	Shrinking due to newer therapies
R&D pipeline	None confirmed	Limited, no upcoming innovations
Pricing power	Limited post-patent	Weakens further with generics

Key Takeaways

1. Edurant faces declining revenue prospects due to patent expiration and increasing generic competition.
2. Its position is mainly within the mature HIV treatment market, where new therapies are capturing more share.
3. Limited innovation limits long-term growth potential; incremental opportunities hinge on future formulations.
4. Short-term cash flows remain stable but will deteriorate without pipeline or formulation improvements.
5. Investment risk escalates as pricing pressures and market saturation intensify.

FAQs

Q1: Will Edurant regain market share with new formulations?
A: No evidence suggests planned long-acting or injectable rilpivirine formulations, limiting prospects.

Q2: How does patent expiry impact future sales?
A: Patent expiry opens the market to generic versions, significantly reducing revenue margins and volumes.

Q3: Are there any potential licensing or partnership opportunities?
A: Likely limited; Janssen has shifted focus to pipeline drugs, reducing licensing interest in rilpivirine.

Q4: What is the outlook for emerging markets?
A: Growth potential exists but faces barriers from pricing and infrastructure; competition from generics will influence pricing.

Q5: Should investors focus on Edurant or newer drugs?
A: Newer drugs with better efficacy, safety, and formulations dominate the market; Edurant's prospects are limited.

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References

[1] IQVIA. (2022). Global HIV Market Report. IQVIA Institute for Human Data Science.
[2] U.S. Food & Drug Administration. (2011). Edurant (rilpivirine) approval letter.
[3] Johnson & Johnson. (2022). Annual report and sales overview.
[4] MarketWatch. (2023). HIV therapeutics market analysis.
[5] European Medicines Agency. (2022). Market authorization details for rilpivirine.