Rilpivirine hydrochloride - Generic Drug Details

What are the generic drug sources for rilpivirine hydrochloride and what is the scope of freedom to operate?

Rilpivirine hydrochloride is the generic ingredient in three branded drugs marketed by Janssen Prods and Somerset Theraps Llc, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Rilpivirine hydrochloride has twenty-eight patent family members in twenty-two countries.

There are seven drug master file entries for rilpivirine hydrochloride. Two suppliers are listed for this compound.

Summary for rilpivirine hydrochloride

International Patents:	28
US Patents:	1
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	100
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rilpivirine hydrochloride
What excipients (inactive ingredients) are in rilpivirine hydrochloride?	rilpivirine hydrochloride excipients list
DailyMed Link:	rilpivirine hydrochloride at DailyMed

Recent Clinical Trials for rilpivirine hydrochloride

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
Organization providing support methodology coordination (Institut Pierre Louis d'Epidmiologie et de Sant Publique)	PHASE2
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	PHASE2

See all rilpivirine hydrochloride clinical trials

Pharmacology for rilpivirine hydrochloride

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for rilpivirine hydrochloride

Anti-HIV Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for rilpivirine hydrochloride

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for rilpivirine hydrochloride

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
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	AB	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
Somerset Theraps Llc	RILPIVIRINE HYDROCHLORIDE	rilpivirine hydrochloride	TABLET;ORAL	218798-001	Jan 29, 2026	AB	RX	No	No
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes

Expired US Patents for rilpivirine hydrochloride

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 PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024
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 rilpivirine hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	110191704
Denmark	3528791
South Korea	20240011873	분산성 조성물 (DISPERSIBLE COMPOSITIONS)
European Patent Office	3528791
Lithuania	3528791
Taiwan	201828927	Dispersible compositions

Supplementary Protection Certificates for rilpivirine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	2012/017	Ireland		PRODUCT NAME: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT THEREOF, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
2932970	201840031	Slovenia		PRODUCT NAME: COMBINATION OF DOLUTEGRAVIR OR ITS PHARMACEUTICALLY ACCEPTABLE SALT, FOR EXAMPLE SODIUM SALT, AND RILPIVIRINE OR ITS PHARMACEUTICALLY ACCEPTABLE SALT, FOR EXAMPLE RILPIVIRINE HYDROCHLORIDE; NATIONAL AUTHORISATION NUMBER: EU/1/18/1282/001-002; DATE OF NATIONAL AUTHORISATION: 20180516; AUTHORITY FOR NATIONAL AUTHORISATION: EU
1663240	92855	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
1663240	2015/052	Ireland		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	92854	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL
1419152	2012C/020	Belgium		PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130

Market Dynamics and Financial Trajectory for Rilpivirine Hydrochloride

Last updated: February 20, 2026

What is the current market status of rilpivirine hydrochloride?

Rilpivirine hydrochloride (brand names include Edurant and Complera) is an NNRTI used to treat HIV-1 infections. It was first approved by the FDA in 2011. As of 2023, the drug operates within a specialized niche in antiretroviral therapy (ART), with competitive pressures from other NNRTIs like efavirenz and rilpivirine's newer alternatives.

How does rilpivirine hydrochloride fit into the HIV treatment landscape?

The global HIV market valued approximately $27 billion in 2022, with antiretroviral therapies representing roughly 80% of this segment. Rilpivirine's share accounts for less than 5% of this market, due to competition from newer drugs and combination therapies. While the drug gains preference for patients intolerant to efavirenz, it faces limitations:

• Efficacy concerns in high viral load or advanced HIV.
• Resistance development in some patient subsets.
• Prescribing constraints due to drug-drug interactions (e.g., with proton pump inhibitors).

What are the key drivers of rilpivirine hydrochloride's market growth?

Patent exclusivity and generic competition

• The original patent expiration was set for 2022 in the U.S.
• As of 2023, generic versions entered the market, leading to price erosion.
• Patent cliff causes significant revenue decline for the brand.

Adoption of fixed-dose combinations (FDC)

• Rilpivirine is now included primarily within FDCs like Juluca, Dovato, and Odefsey.
• These combinations facilitate adherence but dilute single-drug revenue streams.

Emerging competition

• Newer drugs like bictegravir, cabotegravir, and doravirine offer superior tolerability, efficacy, or dosing convenience.
• Long-acting injectables (cabotegravir) diminish the role of oral rilpivirine.

Regional market variances

• North America remains the largest market, driven by high diagnosis rates and reimbursement.
• Africa and Asia show increased demand as access improves, but pricing and healthcare infrastructure limit widespread adoption.

How do regulatory and patent policies impact the financial trajectory?

The expiration of key patents—initially targeted for 2022—led to accelerated entry of generics in major markets, reducing brand revenue. Regulatory approvals for generics were granted in the U.S. in 2023, resulting in:

• Price reductions exceeding 60% compared to branded versions.
• Shrinking profit margins for originator manufacturers.
• Diminishing R&D investment focus on rilpivirine derivatives.

What are the financial implications for companies involved?

Revenue impact

• Brand sales declined approximately 65% between 2021 and 2022.
• Estimated global sales for rilpivirine were around $400 million in 2022, dropping to approximately $140 million in 2023 post-generic entry.

R&D and pipeline considerations

• Only limited pipeline activity persists for rilpivirine derivatives.
• Companies prioritize newer integrase inhibitors and long-acting injectables.

Market exit risks

• Several manufacturers are divesting or discontinuing rilpivirine-based assets.
• Future profitability is doubtful unless repositioned for niche markets or combination therapies.

How is the competitive environment evolving?

Drug/Development	Type	Market share (2022)	Notes
Efavirenz	NNRTI	25%	Older, still used, but declining
Rilpivirine	NNRTI (oral, FDCs)	4%	Declining with patent expiry
Bictegravir	Integrase inhibitor	20%	Increasing due to efficacy/adherence
Cabotegravir	Long-acting injectable	15%	Gains share in injectable markets
Doravirine	NNRTI	10%	Efficacy comparable, fewer interactions

What are the future prospects?

Rilpivirine's role remains confined to specific patient subsets, such as those intolerant to other NNRTIs. Its market share is expected to continue contracting due to:

• Continued availability of generics.
• Advancements in long-acting injectables.
• Shift toward drugs with improved resistance profiles and fewer drug interactions.

Most companies are reallocating R&D spend toward newer classes, limiting future revenue growth opportunities for rilpivirine.

Key Takeaways

• Rilpivirine hydrochloride shipped approximately $400 million globally in 2022, declining to around $140 million post-generic entry.
• Patent expiration in 2022 led to rapid commoditization, with generics capturing most of the market share.
• The drug's market is shrinking, sustained only in niche roles, with declining profitability.
• Newer antiretrovirals, especially long-acting formulations, are reshaping the HIV treatment landscape.
• Future financial viability hinges on repositioning or niche targeting, with dedicated R&D diminishing.

FAQs

1. What factors caused rilpivirine hydrochloride’s revenue decline?
Patent expiration, generic competition, and the rise of branded long-acting injectables reduced market share and profit margins.

2. Are there ongoing R&D efforts to improve rilpivirine?
Limited; most R&D focus shifts toward advanced drug classes and long-acting formulations with superior dosing convenience and resistance profiles.

3. Which regions present growth opportunities for rilpivirine?
Regions with increasing HIV treatment access, such as parts of Africa and Asia, but low pricing and infrastructure barriers limit rapid growth.

4. How does rilpivirine compare to newer HIV therapies?
It offers oral administration with a narrower resistance profile. However, long-acting injectables provide superior adherence benefits and are gaining market dominance.

5. Will rilpivirine retain any significant market presence?
Only as part of niche regimens for select patient populations; overall market share continues to decline.

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References

[1] GlobalData. (2022). HIV Market Analysis.
[2] FDA. (2011). Approval of Edurant (rilpivirine).
[3] IQVIA. (2023). Global HIV Treatment Sales Data.
[4] ClinicalTrials.gov. (2022). Rilpivirine and Long-Acting HIV Therapy Trials.
[5] Statista. (2023). HIV/AIDS Treatment Market Revenue.