CLINICAL TRIALS PROFILE FOR EDURANT

All Clinical Trials for EDURANT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
NCT01467531 ↗	A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects	Completed	Shionogi	Phase 1	2011-11-01	This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
NCT01467531 ↗	A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects	Completed	ViiV Healthcare	Phase 1	2011-11-01	This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
NCT01562886 ↗	The Rilpivirine Cerebrospinal-fluid (CSF) Study	Completed	Janssen-Cilag Ltd.	Phase 1	2012-03-01	This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.
NCT01562886 ↗	The Rilpivirine Cerebrospinal-fluid (CSF) Study	Completed	Imperial College London	Phase 1	2012-03-01	This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.

Clinical Trial Conditions for EDURANT

Condition Name

Condition Name for EDURANT
Intervention	Trials
HIV	3
HIV Infections	2
Contraception	2
HIV-1-infection	1

Condition MeSH

Condition MeSH for EDURANT
Intervention	Trials
HIV Infections	6
Acquired Immunodeficiency Syndrome	4
Immunologic Deficiency Syndromes	4
Infections	3

Clinical Trial Locations for EDURANT

Trials by Country

Trials by Country for EDURANT
Location	Trials
United States	14
Uganda	3
Thailand	2
South Africa	2
United Kingdom	1

Trials by US State

Trials by US State for EDURANT
Location	Trials
New York	2
North Dakota	1
Washington	1
Texas	1
Tennessee	1

Clinical Trial Progress for EDURANT

Clinical Trial Phase

Clinical Trial Phase for EDURANT
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for EDURANT
Clinical Trial Phase	Trials
Completed	6
Unknown status	4
Recruiting	2

Clinical Trial Sponsors for EDURANT

Sponsor Name

Sponsor Name for EDURANT
Sponsor	Trials
University of Liverpool	2
University of Nebraska	2
University of Pittsburgh	2

Sponsor Type

Sponsor Type for EDURANT
Sponsor	Trials
Other	14
Industry	10
NIH	1

Last updated: July 30, 2026

Edurant (rilpivirine) clinical trials update, market analysis and generic/biosimilar exclusivity outlook

Edurant (rilpivirine) remains a marketed HIV regimen component with no biosimilar pathway. The IP and regulatory landscape is dominated by legacy small-molecule protections and historical FDA exclusivity. Market growth is constrained by mature uptake, regimen standard-of-care shifts, and aggressive competition from newer fixed-dose integrase-based combinations.

What is the current clinical trial landscape for Edurant (rilpivirine)?

Featured answer: Edurant’s active clinical development footprint is limited versus newer HIV drugs. Rilpivirine’s late-stage focus in recent years has typically centered on label optimization, real-world cohorts, and regimen-switch studies rather than new late-stage registration programs.

What trial types are most common for rilpivirine updates

• Comparative effectiveness and safety in routine-care cohorts
• Pharmacokinetic (PK) bridging and drug-drug interaction (DDI) assessments
• Switch studies from older antiretroviral combinations to rilpivirine-containing regimens
• Formulation work that supports dosing flexibility or adherence in practice

What endpoints are tracked in rilpivirine studies

• Virologic suppression rates (HIV-1 RNA <50 copies/mL; also <200 copies/mL depending on protocol)
• Resistance emergence (baseline resistance-associated substitutions and post-switch genotypes)
• CD4 cell count dynamics
• Safety and tolerability (QTc, neuropsychiatric adverse events, rash)
• Adherence-related outcomes in real-world settings

How big is the Edurant (rilpivirine) market, and where is demand concentrated?

Featured answer: Edurant is a niche share-holder within the global antiretroviral market, with demand concentrated in countries and payer systems where rilpivirine-containing regimens remain in use for specific patient profiles. Uptake growth is modest because integrase-based fixed-dose regimens dominate first-line and many switch pathways.

Market sizing approach used for rilpivirine

For mature HIV franchises, market projections usually scale from:

• Branded volume trajectories (to the extent publicly available via IQVIA and similar datasets)
• Generic erosion in the underlying active ingredient lifecycle
• Switching dynamics driven by guideline updates and fixed-dose preferences

Key demand drivers

• Patient selection: use in regimens where prior viral suppression supports continuation
• Tolerability and regimen simplicity in specific clinical workflows
• Formulary placement in established treatment plans
• Competition pressure from newer once-daily combination products

Key headwinds

• Guideline migration toward integrase-based regimens as default
• Competitive branded and generic pressure that reduces branded rilpivirine mix
• Longer-term generic substitution risk once core compound and composition protections are fully worked through

When does Edurant lose exclusivity and how does that affect pricing?

Featured answer: Edurant’s compound-era exclusivity is long past; the practical driver now is patent and market exclusivity history plus ongoing generic substitution dynamics rather than active regulatory exclusivity.

What matters for pricing now

• Availability of generic rilpivirine (or combination equivalents, where applicable)
• Patent-by-patent enforceability remnants in specific jurisdictions
• Payer contracting that pushes down branded net prices once competitors gain shelf access
• Use of guideline-aligned regimens that displace older components

Timeline framing for small-molecule HIV agents

• Initial FDA approval and subsequent lifecycle filings (salt/formulation/method)
• Later patent expiry and resolution of any generic challenges
• Post-expiry pricing compression and volume migration to generics or alternative brands

What patents protect Edurant (rilpivirine), and what claim types matter for generic entry?

Featured answer: For mature small-molecule HIV products, the most relevant claim sets to generics are typically composition-of-matter and specific formulation or dosing method claims, followed by any method-of-treatment claims tied to identified patient populations or therapeutic regimens.

How to evaluate the strength of a rilpivirine patent estate

Patent estates are usually assessed across:

• Composition-of-matter claims (active ingredient and specific chemical definitions)
• Formulation claims (tablet composition, excipients, particle engineering where claimed)
• Method-of-use claims (specific dosing regimens, patient-response criteria)
• Secondary patents (process/method for manufacturing, polymorph claims if applicable)
• Continuations and jurisdiction-specific continuations that extend practical enforceability

What creates entry barriers after compound expiry

Even when the base compound is off-patent, entry can be delayed by:

• Formulation or process patents still in force
• Method-of-use claims that map to approved labeling or enforceable treatment protocols
• Country-specific patent validity and injunction outcomes

Are there Paragraph IV challenges or ANDA litigation risks for Edurant generics?

Featured answer: For legacy rilpivirine products, generic entry risk is driven by the availability of ANDA alternatives and the resolution history of any Orange Book-listed patents. The current litigation risk is assessed by whether Orange Book protections remain enforceable and whether any generic applicants are actively litigating.

What to check for litigation posture

• Orange Book listing persistence for any Edurant-associated patents
• Court case status (if any) tied to rilpivirine tablet or related dosage forms
• Settlement terms that define “at-risk” launch dates

What is the Orange Book status of Edurant (rilpivirine)?

Featured answer: Edurant’s current Orange Book status is characterized by mature listing activity with limited practical protection relevance at this stage. The controlling variable is whether any remaining listed patents still have unexpired claim terms or active enforcement.

What Orange Book listings typically reveal

• Which patents are tied to drug substance vs drug product
• Whether formulation patents remain listed
• Whether any listed patents are tied to exclusivity rather than patent claims

How does Edurant compare with other HIV regimen components in market trajectory?

Featured answer: Edurant competes primarily as a branded component inside clinician-selected combination regimens, while overall market share shifts toward newer integrase-based fixed-dose combinations.

Competitive comparison dimensions

• Guideline alignment (first-line and switch positioning)
• Fixed-dose preference and pill burden reduction
• Resistance barrier and resistance pattern flexibility
• Drug-drug interaction profile and dietary restrictions (relevant to rilpivirine)
• Tolerability and QT-related monitoring considerations

What generic entry scenarios could affect Edurant volume and revenue?

Featured answer: Generic entry scenarios now are mostly about whether branded net losses accelerate due to increased generic availability, payer switch protocols, and formulary contracting. The higher-risk scenario is rapid conversion of branded-prescribed patients to lower-cost alternatives after any remaining enforceable protections are removed.

Entry scenario map

• Base case: gradual volume mix erosion as generics capture stable payer segments
• Aggressive case: rapid displacement after additional competitor launches or formulary re-bids
• Resilience case: payer and clinician inertia tied to patient-specific suitability and established treatment continuity

How will biosimilar risk apply to Edurant?

Featured answer: Biosimilar risk does not apply because Edurant is a small-molecule drug (rilpivirine), not a biologic. Competitive pressure comes from small-molecule generics and fixed-dose combination products, not biosimilars.

What manufacturing and formulation/IP barriers exist for rilpivirine tablets?

Featured answer: Manufacturing and formulation barriers are typically less about complex biologics and more about specific formulation claims, excipient definitions, and any process claims that remain enforceable.

What can still delay generic rilpivirine entry

• Unexpired formulation or process patents
• Data exclusivity or labeling-dependent constraints for certain generic paths
• Need for clinical bridging if labeling design or release profile differs materially from the reference product

Clinical and commercial projection: Edurant’s likely 12-to-36 month outlook

Featured answer: Over the next 12 to 36 months, Edurant’s revenue trajectory is expected to remain under pressure from mature-market dynamics: generic mix expansion, guideline-driven regimen shifts, and payer-driven net price reductions. The most likely upside is stable demand from existing suppressed patients that remain on rilpivirine-based regimens where clinically appropriate.

Projected drivers

• Continued erosion of branded pricing power
• Slow-down in patient initiation if new starts shift to newer combinations
• Persistence of maintenance therapy share among stable patients
• Any incremental new data that supports continued use in label-consistent scenarios

Projection framing (business-useful)

• Volume: likely stable-to-declining as new starts are constrained
• Price: net price likely down or flat at lower levels due to contracting dynamics
• Revenue: modest decline or flat-to-down range depending on region-specific formulary retention

Key Takeaways

• Edurant’s clinical activity is mostly label optimization, PK/DDI, and regimen-switch support rather than new late-stage registrations.
• Market growth is constrained by mature HIV prescribing patterns and the dominance of integrase-based fixed-dose regimens.
• Biosimilar risk is not relevant; competitive pressure is generic small-molecule substitution and combination switching.
• Future revenue exposure is driven by remaining enforceable patents (if any), Orange Book persistence, and payer contracting speed rather than new clinical breakthroughs.

FAQs

1. What drugs are most likely to displace Edurant (rilpivirine) in treatment guidelines?
2. How do rilpivirine food and drug-drug interaction constraints affect real-world regimen persistence?
3. What Orange Book patent types (drug substance vs drug product) most influence generic timing for rilpivirine tablets?
4. What resistance-associated substitutions most affect continued use of rilpivirine in suppressed patients?
5. What fixed-dose combination switches are commonly used when replacing rilpivirine-containing regimens?

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drug approvals and labeling for Edurant (rilpivirine). FDA.
3. ClinicalTrials.gov. Studies for rilpivirine (Edurant). National Institutes of Health.
4. U.S. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. DHHS.