EDURANT Drug Patent Profile

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

Edurant is a drug marketed by Janssen Prods and is included in two NDAs. There are three patents protecting this drug.

This drug has one hundred and ninety-nine patent family members in forty-two countries.

The generic ingredient in EDURANT 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

Edurant was eligible for patent challenges on May 20, 2015.

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

International Patents:	199
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	14
Patent Applications:	560
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

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

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

202022

Dosage:

TABLET;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

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 one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on NEW PATIENT POPULATION.

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	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		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			Y	Y
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes
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
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011

International Patents for EDURANT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1632232	Sel de 4-[[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyl]amino]-2-Pyrimidinyl]amino]benzonitrile (Salt of 4[[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyl]amino]-2-Pyrimidinyl]amino]benzonitrile)
Australia	2019200813	Combinations of a pyrimidine containing NNRTI with RT inhibitors
China	102319433	Combinations of a pyrimidine containing nnrti with rt inhibitors
Norway	340654
Croatia	P20150798
South Korea	20060090658	COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS

Supplementary Protection Certificates for EDURANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	1890039-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
1663240	C01663240/02	Switzerland		FORMER OWNER: JANSSEN SCIENCES IRELAND UC, IE
1663240	C20150039 00166	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA EMTRITSITABIINI;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
2932970	2018C/041	Belgium		PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD DOLUTEGRAVIRNATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD RILPIVIRINEHYDROCHLORIDE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
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
1663240	2016/058	Ireland		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457)

Market Dynamics and Financial Trajectory for EDURANT (Rilpivirine)

Last updated: August 22, 2025

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Introduction

EDURANT (rilpivirine) is an antiretroviral drug developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Approved initially in 2011, EDURANT is prescribed primarily for the treatment of HIV-1 infections. Its emergence as part of combination therapy contributed significantly to the landscape of HIV management. As with many pharmaceutical agents targeting chronic conditions, understanding its market dynamics and financial trajectory requires a comprehensive analysis of clinical positioning, competitive pressures, patent status, regulatory landscape, and evolving treatment guidelines.

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Market Landscape for HIV Antiretroviral Agents

The global HIV therapeutics market, estimated at approximately $29 billion in 2022, continues to grow driven by increasing HIV incidence, longer lifespans of infected individuals, and evolving treatment paradigms emphasizing patient adherence and quality of life [1]. Within this context, EDURANT occupies a niche as an NNRTI (non-nucleoside reverse transcriptase inhibitor), competing with agents like efavirenz and doravirine.

The therapy landscape is characterized by a shift toward single-tablet regimens (STRs) offering simplified dosing and better adherence. The commoditization of generic drugs also influences market shares and revenue potential for branded drugs like EDURANT.

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Market Dynamics Influencing EDURANT

1. Competitive Positioning and Pharmacology

EDURANT's once-daily dosing and favorable side effect profile initially provided advantages over efavirenz, especially regarding neuropsychiatric adverse effects. However, subsequent development of newer agents such as doravirine and integrase inhibitors (e.g., dolutegravir, bictegravir) offer more potent, tolerable, and resistance-averse options [2].

2. Patent Expiration and Generic Competition

The original patent protection for EDURANT expired or is nearing expiration in various jurisdictions, opening opportunities for generic manufacturers to enter the market. This patent cliff is a pivotal factor diminishes revenue streams for branded EDURANT and drives down prices, impacting the drug’s financial trajectory:

• Patent Timeline: EDURANT's patent was listed in the U.S. until around 2028, with patent extensions possibly delaying generic entry in specific markets [3].

• Implications: Once generics penetrate the market, a significant decline in sales and profit margins is inevitable, unless brand strategies pivot toward niche markets or combination therapies.

3. Regulatory and Clinical Practice Trends

Regulatory agencies emphasize therapies with better safety and efficacy profiles. The increasing preference for integrase inhibitor-based regimens, which demonstrate higher barriers to resistance, diminishes EDURANT’s clinical prominence [4].

Similarly, evolving treatment guidelines favor integrase-based STRs, making EDURANT less central in first-line therapy. This diminishes its market share and long-term revenue prospects.

4. Pricing Strategies and Reimbursement Models

Pricing pressures are intensifying, especially with the rise of generic competition and payers' cost-containment strategies. EDURANT's premium pricing is challenged by cheaper alternatives, especially in markets favoring cost-effectiveness. Reimbursement policies and formulary placements significantly influence prescription volumes.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

Janssen reported peak sales of EDURANT in the mid-2010s, coinciding with its initial launch and adoption within treatment guidelines. However, subsequent years witnessed a steady decline attributable to patent expiration, evolving standards of care, and market saturation.

In 2021, EDURANT sales declined by approximately 10-15% compared to previous years, reflecting intensifying generic competition and preference for newer agents. Exact revenue figures, combined with Janssen’s filings, suggest that EDURANT’s contribution to overall HIV drug revenue has diminished significantly [5].

Projected Outlook

Given current patent expiries, the outlook indicates a continued downward trajectory:

• Short-term (1-3 years): Gradual decline as generics enter, with revenues potentially halving by 2025.

• Medium to Long-term (4-10 years): Limited prospects for growth unless the drug is repositioned or integrated into combination therapies; revenue could decline to negligible levels post-patent expiry.

Janssen may explore strategic licensing, combination formulations, or niche applications, but current data suggest diminishing financial importance for EDURANT.

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Strategic Implications for Stakeholders

• Pharmaceutical companies should monitor patent statuses, develop lifecycle management strategies, and invest in next-generation NNRTIs or alternative therapeutics.

• Investors must account for revenue erosion risks and consider the drug’s position within Janssen’s broader HIV portfolio.

• Healthcare providers should stay updated on evolving treatment guidelines to optimize patient outcomes with the most effective and cost-efficient regimens.

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Conclusion

EDURANT's market dynamics are characterized by early dominance followed by a decline driven by patent expiration, competition from newer agents, and shifts in treatment paradigms favoring integrase inhibitors. While initial revenues were promising, the drug's long-term financial trajectory appears bleak absent strategic repositioning. Stakeholders must prepare for a phased market exit or transformation, emphasizing the importance of innovation and lifecycle management in the pharmaceutical industry.

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Key Takeaways

• EDURANT initially captured significant market share through its ease of use and tolerability, but newer therapies have overtaken it.

• Patent expiration and generic competition are primary drivers of declining revenues, with projections indicating a sharp decline in the next few years.

• Shifts in clinical guidelines favor integrase inhibitors, marginalizing EDURANT’s role in HIV management.

• Strategic diversification into combination therapies and lifecycle extensions are crucial to sustain revenue streams.

• The drug’s financial trajectory underscores the importance of continuous innovation and regulatory foresight in the pharmaceutical industry.

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FAQs

1. What factors contributed to EDURANT's initial market success?
Its once-daily dosing, favorable side effect profile, and positioning as an effective NNRTI fostered early adoption in HIV treatment, especially before the advent of newer agents.

2. How does patent expiration impact EDURANT’s market presence?
Patent expiration opens the door for generic competitors, drastically reducing branded sales and profit margins, often leading to phased market exit.

3. Are there ongoing efforts to repurpose or reformulate EDURANT?
Currently, there are limited efforts; focus has shifted toward developing next-generation NNRTIs and integrase inhibitors with improved profiles.

4. How do treatment guideline shifts influence EDURANT's market trajectory?
Guidelines favor integrase-based regimens, relegating EDURANT to secondary options, which diminishes its prescription volume.

5. What strategic options exist for Janssen regarding EDURANT?
Diversifying into combination therapies, licensing, or repositioning the drug for niche indications are potential strategies, but prospects are uncertain given current market trends.

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References

[1] Global HIV Therapeutics Market Report, 2022.

[2] Clinical guidelines for HIV treatment, CDC, 2021.

[3] Patent databases and expiration timelines, USPTO.

[4] Treatment guideline updates, World Health Organization, 2022.

[5] Janssen Pharmaceuticals Financial Reports, 2015-2021.