RILPIVIRINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for rilpivirine hydrochloride and what is the scope of patent protection?

Rilpivirine hydrochloride is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rilpivirine hydrochloride has two hundred and twenty-one patent family members in forty-five countries.

There are seven drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.

Summary for RILPIVIRINE HYDROCHLORIDE

International Patents:	221
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	89
Patent Applications:	286
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

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

Constraining patent/regulatory exclusivity:

7,125,879*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

7,125,879

Dosage:

TABLET, FOR SUSPENSION;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 RILPIVIRINE HYDROCHLORIDE

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

Sponsor	Phase
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2
Janssen Research & Development, LLC	Phase 1/Phase 2

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		DISCN	Yes	No	7,125,879		Y	Y
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes	7,125,879*PED				Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		DISCN	Yes	No	11,065,198		Y

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	8,101,629
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	8,080,551
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	7,067,522

International Patents for RILPIVIRINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Norway	2016025
South Korea	101539245
South Korea	20240011873	분산성 조성물 (DISPERSIBLE COMPOSITIONS)
Hungary	S1600059
Taiwan	I315199
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)
Eurasian Patent Organization	006656	ПРОИЗВОДНЫЕ ПИРИМИДИНА, ИНГИБИРУЮЩИЕ ВИЧ (HIV INHIBITING PYRIMIDINES DERIVATIVES)

Supplementary Protection Certificates for RILPIVIRINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	PA2022515,C3808743	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152	PA2012009,C1419152	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1663240	379 5033-2016	Slovakia		PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1419152	132012902053326	Italy		PRODUCT NAME: RILPIVIRINA CLORIDRATO(EDURANT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/736/001, 20111128
1419152	2012C/020	Belgium		PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130
1663240	60/2015	Austria		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
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

RILPIVIRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rilpivirine Hydrochloride

Introduction to Rilpivirine Hydrochloride

Rilpivirine hydrochloride, marketed under the brand name Edurant, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other HIV medicines to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children from 2 years of age[1][2].

Mechanism of Action and Clinical Use

Rilpivirine hydrochloride works by inhibiting the reverse transcriptase enzyme, which is crucial for the replication of HIV. This mechanism makes it an effective component of antiretroviral therapy (ART) regimens. It is available in various formulations, including oral tablets and a long-acting injectable form[2].

Market Size and Growth

The global HIV drugs market, within which rilpivirine hydrochloride is a significant player, was valued at $34.13 billion in 2023. This market is expected to grow to $58.24 billion by 2032, with a compound annual growth rate (CAGR) of 6.2% during the forecast period from 2024 to 2032. The increasing patient population, new product launches, and government initiatives to improve access to HIV diagnosis and treatment are key drivers of this growth[3].

Segmentation and Distribution Channels

The HIV drugs market is segmented into various product types, including combination HIV medicines, protease inhibitors, fusion inhibitors, and others. The combination HIV medicines segment, which includes rilpivirine hydrochloride, is expected to lead the market during the forecast period. In terms of distribution channels, hospital pharmacies are projected to hold the dominant share due to the high volume of prescribed antiretroviral drugs dispensed through these channels[3].

Regional Market Dynamics

North America, particularly the United States, dominates the HIV drugs market due to the high prevalence of HIV infection and strong awareness among the population. As of 2023, the North American market stood at $24.09 billion. The Asia Pacific region is anticipated to be the fastest-growing market, driven by highly populated countries like China and India, along with increasing treatment programs and funding from healthcare companies[3].

Competitive Landscape

The global HIV drugs market is highly competitive, with key players such as ViiV Healthcare, Gilead Sciences, Janssen Pharmaceuticals, and Merck. These companies dominate the market through strong sales of antiretroviral drugs, new product launches, and strategic collaborations. For instance, Gilead Sciences and Merck have collaborated on the co-development and co-commercialization of long-acting treatments for HIV patients[3].

Patent and Regulatory Status

Rilpivirine hydrochloride, under the brand name Edurant, is protected by a significant number of patents globally, with 199 patent family members in 42 countries. The earliest date for generic entry is expected to be October 21, 2025, although this may change due to patent challenges or generic licensing. There have been several patent litigation cases, indicating strong interest in generic versions of the drug[5].

Financial Performance and Projections

The financial performance of rilpivirine hydrochloride is closely tied to the overall HIV drugs market. With the market expected to grow significantly over the next decade, the revenue generated from Edurant and its formulations is likely to increase. The launch of new formulations, such as the long-acting injectable form, and the expansion into new markets, particularly in developing regions, will further contribute to the financial growth of rilpivirine hydrochloride.

Impact of COVID-19

The COVID-19 pandemic had an adverse impact on the HIV drugs market, including rilpivirine hydrochloride, due to disruptions in the supply chain and a decrease in new patient prescriptions in affected regions. However, as the pandemic's impact subsides, the market is expected to recover and continue its growth trajectory[3].

Future Outlook

The future outlook for rilpivirine hydrochloride is positive, driven by increasing awareness of HIV/AIDS, government initiatives to improve access to treatment, and the launch of new and innovative formulations. The long-acting injectable form of rilpivirine hydrochloride, for example, offers a more convenient treatment option for patients, which is likely to enhance market penetration.

Key Statistics and Trends

• Market Size: The global HIV drugs market was valued at $34.13 billion in 2023 and is expected to reach $58.24 billion by 2032[3].
• CAGR: The market is expected to grow at a CAGR of 6.2% from 2024 to 2032[3].
• Regional Dominance: North America dominated the market in 2023, with a market size of $24.09 billion[3].
• Distribution Channels: Hospital pharmacies are projected to hold the largest market share during the forecast period[3].
• Patent Expiration: The earliest date for generic entry of rilpivirine hydrochloride is expected to be October 21, 2025[5].

Key Takeaways

• Rilpivirine hydrochloride is a crucial antiretroviral drug used in the treatment of HIV-1 infection.
• The global HIV drugs market is expected to grow significantly, driven by increasing patient populations and new product launches.
• North America and the Asia Pacific region are key markets for rilpivirine hydrochloride.
• The drug is protected by a substantial number of patents, with generic entry expected in 2025.
• The COVID-19 pandemic had a temporary adverse impact on the market, but recovery is anticipated.

Frequently Asked Questions

1. What is rilpivirine hydrochloride used for?

Rilpivirine hydrochloride, marketed as Edurant, is used in combination with other HIV medicines to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children from 2 years of age[1].

2. How does rilpivirine hydrochloride work?

Rilpivirine hydrochloride works by inhibiting the reverse transcriptase enzyme, which is essential for the replication of HIV[2].

3. What is the current market size of the global HIV drugs market?

The global HIV drugs market was valued at $34.13 billion in 2023 and is expected to grow to $58.24 billion by 2032[3].

4. Which regions are expected to drive the growth of the HIV drugs market?

North America and the Asia Pacific region are anticipated to be the key drivers of the HIV drugs market growth. North America dominates the market due to high prevalence and awareness, while the Asia Pacific region is expected to be the fastest-growing market[3].

5. When is the patent for rilpivirine hydrochloride expected to expire?

The earliest date for generic entry of rilpivirine hydrochloride is expected to be October 21, 2025, although this may change due to patent challenges or generic licensing[5].

Sources:

1. European Medicines Agency. Edurant | European Medicines Agency (EMA).
2. AdisInsight - Springer. Rilpivirine - Janssen.
3. Fortune Business Insights. HIV Drugs Market Size & Growth | Global Report [2024-2032].
4. Stratagem Market Insights. Rilpivirine Hydrochloride Market Insight, Size, Share, Growth, Up-To ...
5. Drug Patent Watch. EDURANT Drug Patent Profile.