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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	14
Patent Applications:	524
Drug Prices:	Drug price information for EDURANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDURANT
What excipients (inactive ingredients) are in EDURANT?	EDURANT excipients list
DailyMed Link:	EDURANT at DailyMed

See drug prices for EDURANT

Recent Clinical Trials for EDURANT

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

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

See all EDURANT clinical trials

Pharmacology for EDURANT

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

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	11,065,198		Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes

Expired US Patents for EDURANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	6,838,464
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	7,638,522
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	8,101,629
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	8,080,551
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	7,067,522

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
Canada	2398887	2,4,DI-(HETERO-) ARYLAMINO (-OXY)-5 PYRIMIDINES SUBSTITUTEESUTILISEES COMME AGENTS ANTINEOPLASIQUES (2,4,DI(HETERO-)ARYLAMINO(-OXY)-5-SUBSTITUTED PYRIMIDINES AS ANTINEOPLASTIC AGENTS)

Supplementary Protection Certificates for EDURANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	C300529	Netherlands		PRODUCT NAME: RILPIVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT, IN HET BIJZONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1419152	C300532	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152	PA2012008	Lithuania		PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1419152	PA2012009	Lithuania		PRODUCT NAME: EMTRICITABINUM + RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1419152	CA 2012 00021	Denmark
1419152	CA 2012 00019	Denmark

EDURANT (rilpivirine): Market Dynamics and Financial Trajectory for Janssen’s HIV Revenue Engine

Last updated: July 29, 2026

EDURANT (rilpivirine) is an NRTI-sparing, second-generation NNRTI for HIV-1 infection. Its commercial trajectory is shaped by cohort migration from older NNRTI backbones toward high-barrier integrase inhibitor (INSTI) regimens, coupled with payer shift, formulary tier pressure, and the growing share of long-acting (injectable) and INSTI-based fixed-dose combinations. The near- and mid-term revenue outlook depends on (i) how durable rilpivirine remains in guideline-preferred first-line and switch populations, (ii) generic erosion risk across oral rilpivirine strengths and combinations in the US, and (iii) geographic performance outside the US where formulary structures still support NNRTI continuity.

What is the market position of EDURANT (rilpivirine) in HIV therapy?

EDURANT’s role is narrower than it was at launch. The HIV market’s dominant clinical and guideline flow has moved toward INSTI-centric single-tablet regimens and, increasingly, long-acting injectable options. Rilpivirine maintains utility primarily in:

• People with suppressed virus on an NNRTI-containing regimen seeking regimen simplification.
• Treatment-naïve patients meeting viral load and CD4 criteria and using recommended dosing parameters.
• Second-line switching where prescribers retain familiarity with NNRTI tolerability profiles.

Commercially, EDURANT competes in the “oral backbone” layer of combination therapy rather than owning a broad class-of-therapy monopoly. That makes it sensitive to formulary design: if payers assign NNRTIs to lower tiers or require step edits before INSTI options, EDURANT’s market access compresses.

How does EDURANT compete versus INSTI-based standards?

• Switch pressure: INSTI regimens often dominate formularies due to efficacy, resistance forgiveness characteristics (depending on regimen and patient context), and simpler resistance pathways than NNRTI. This drives share loss even when EDURANT remains clinically appropriate.
• New entrants and pipeline gravity: The HIV treatment market favors incremental advantages in tolerability, resistance profiles, and dosing convenience. EDURANT’s once-daily oral dosing is convenient, but it is not in the same “dosing innovation” category as long-acting injectables.

What market dynamics drive EDURANT demand and pricing?

Featured snippet answer: EDURANT demand is driven by regimen switching among virologically suppressed patients, payer formulary placement, and dosing-adherence constraints tied to food and absorption requirements; pricing is pressured by class competition and increasing generic and therapeutic alternatives over time.

Key demand drivers

• Treatment continuity: Patients stable on an NNRTI backbone tend to avoid change absent safety, resistance, or access reasons.
• Adherence architecture: Rilpivirine has absorption constraints related to food; this shapes real-world dosing adherence patterns, which in turn affects persistence and prescribing behavior.
• Guideline fit: EDURANT remains a known option where NNRTIs are considered acceptable, but most prescribers default to INSTI backbones for first-line simplicity.

Key pricing and access drivers

• Formulary tiering and rebate economics: NNRTI positioning in payer formularies typically faces downward pressure as INSTIs maintain higher preferred access. Manufacturers compete through rebates rather than list price growth.
• Generic and parallel supply: Oral rilpivirine products have become more exposed to generic competition in jurisdictions where regulatory exclusivity barriers lapse and manufacturing economics favor multiple suppliers.

How has EDURANT’s financial trajectory evolved over time?

EDURANT’s financial trajectory follows a common mature-HIV-product pattern: launch growth followed by plateau and then gradual erosion as formularies and prescribing patterns tilt toward newer INSTI regimens and, in some geographies, long-acting therapies.

Typical phases observed for mature HIV oral brands

1. Launch and early uptake: Rapid adoption in combination therapy due to efficacy and tolerability and because NNRTI backbones were widely used.
2. Guideline-driven share compression: As INSTI regimens became preferred, EDURANT’s share in treatment-naïve patients narrowed.
3. Persistence-driven remainder: Revenue increasingly depended on switches from INSTI alternatives when clinicians targeted patient-specific factors or maintained existing viral suppression regimens.
4. Access pressure and pricing compression: Increased competitive density, including generics and class alternatives, reduced net price resilience.

Because EDURANT is a branded oral component within a combination therapy ecosystem, the revenue impact also depends on how often it is included in fixed-dose combinations and how prescribers structure regimen selection. When rilpivirine is not embedded in preferred single-tablet pathways, brand economics typically soften faster.

What is the EDURANT revenue exposure by region and payer segment?

EDURANT’s exposure is concentrated in:

• US: Payer formularies and rebate pressure drive net revenue volatility for mature oral ARVs. Erosion risk accelerates when competing generics or alternative branded INSTI regimens secure preferred status.
• Europe and other OECD markets: Access is shaped by national formularies and HTA-driven pricing dynamics. NNRTI products often experience pressure as INSTIs dominate.
• Middle-income markets: Demand can persist where switching to INSTI-only pathways is constrained by budget, supply continuity, and local prescribing patterns. However, pricing pressure and generic penetration still typically increase over time.

Net effect: EDURANT revenue becomes more dependent on continuity care and less dependent on new patient starts as INSTI regimens maintain market gravity.

What generic and biosimilar risks affect EDURANT (rilpivirine)?

EDURANT is a small-molecule drug, so “biosimilar risk” is not the relevant category. The principal risk is generic erosion across rilpivirine oral products (including strengths and any fixed-dose combinations that include rilpivirine, if applicable by market).

What generic entry risks exist for EDURANT?

• Oral small-molecule generic substitution: Once key patents and exclusivities expire in a jurisdiction, generic rilpivirine products typically capture volume quickly if formulary barriers are minimal.
• Therapeutic substitution: Even with patent protection in place, prescribers can shift to other NNRTIs or to INSTI-based regimens. This is not a legal entry risk, but it is a commercial replacement risk.

What is the Orange Book status of EDURANT and related rilpivirine products?

Featured snippet answer: The US patent and exclusivity landscape determines whether generic entry can occur via ANDA. For EDURANT, Orange Book listings and patent expirations drive timing for Paragraph IV challenges and generic launch readiness.

A complete Orange Book status table requires:

• Each listed drug product (strength/formulation), active ingredient form, and NDC
• All Orange Book patents with expiration dates
• Pediatric exclusivity, 5-year/6-year exclusivity flags (if any), and any later exclusivity extensions

This information is not provided in the prompt, so no reliable Orange Book status mapping can be produced here.

What patents protect EDURANT and how do they affect market durability?

A full patent estate view for EDURANT requires validated, product-specific patent listings (not class-level assumptions). Without the active patent list, assignees, claim coverage summary, and expiration dates, a defensible “patent strength” assessment cannot be produced.

How do EDURANT patent and exclusivity timelines influence competitor entry?

Competitor entry in HIV oral small molecules depends on:

• Expiration of composition-of-matter and key formulation/process patents
• Any exclusivity that delays ANDA approval
• Timelines for generic label alignment, including bioavailability requirements tied to food effects
• Settlement or litigation outcomes (if Paragraph IV filings occurred)

No transaction timeline can be stated without the underlying Orange Book and litigation docket records.

Which companies are competing with EDURANT in the HIV oral NNRTI segment?

EDURANT’s competitive set typically includes:

• Other NNRTI brands and their generic equivalents
• INSTI-based regimens that compete at the regimen level
• Combination products and fixed-dose strategies that displace monocomponent NNRTI backbones

A company-by-company competitive map with market share needs validated market share data and product-specific US and ex-US competitive listings. Those figures are not included in the prompt.

What EDURANT litigation and settlement events matter for market timing?

For US generic entry, the critical items are:

• Paragraph IV certifications for rilpivirine products
• Filed ANDAs and their granted approvals
• Litigation outcomes and any “30-month stay” impact
• Authorized generic or settlement-triggered market entry dates

This requires docket-level and Orange Book-based verification that is not present in the prompt.

How does EDURANT compare financially with competing HIV regimens?

EDURANT’s financial performance should be evaluated as a component within combination therapy, not in isolation:

• If prescribers move patients to INSTI single-tablet regimens, EDURANT share declines even if EDURANT maintains some persistence.
• If a competitor’s regimen is preferred due to formulary position, prior authorization rules, and payer contracting, EDURANT net price and volume both compress.
• Long-acting injectables can further reduce oral maintenance switching, shrinking NNRTI backbone demand over time.

A rigorous comparison requires segment-level unit and net sales data by drug, which is not included in the prompt.

Key Takeaways

• EDURANT’s market is mature and increasingly driven by patient continuity and switching rather than new treatment initiations.
• INSTI-led prescribing and formulary preference have structurally constrained EDURANT share growth and accelerated pricing pressure.
• The primary competitive and erosion risk is generic oral rilpivirine substitution and regimen-level displacement to INSTI alternatives, not biosimilar entry.
• A defensible view of exclusivity and generic launch risk requires product-specific Orange Book and litigation/settlement facts, which are not provided here.

FAQs

1. When do rilpivirine products face generic launch timing in the US based on patent expirations?
2. How does rilpivirine’s food-effect dosing requirement influence adherence and persistence compared with INSTIs?
3. Which payer formulary rules most commonly drive switching away from oral NNRTI backbones like EDURANT?
4. What is the typical impact of US rebate pressure on net sales for mature HIV oral brands such as EDURANT?
5. How do long-acting injectable HIV therapies indirectly reduce demand for EDURANT in maintenance populations?

References

1. Not available.

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