EDURANT PED Drug Patent Profile

When do Edurant Ped patents expire, and what generic alternatives are available?

Edurant Ped is a drug marketed by Janssen Prods and is included in one NDA. There are two patents protecting this drug.

This drug has two hundred and twenty-one patent family members in forty-five countries.

The generic ingredient in EDURANT PED 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 Ped

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 21, 2025. 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 PED

International Patents:	221
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	14
Patent Applications:	99
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDURANT PED
DailyMed Link:	EDURANT PED at DailyMed

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

NDA:

219016

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 EDURANT PED

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 PED clinical trials

Pharmacology for EDURANT PED

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 PED

EDURANT PED is protected by two US patents.

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 PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		DISCN	Yes	No			Y	Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		DISCN	Yes	No			Y

International Patents for EDURANT PED

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

Country	Patent Number	Title	Estimated Expiration
Japan	4922937
Serbia	65159	DISPERZIBILNI SASTAVI (DISPERSIBLE COMPOSITIONS)
South Korea	101539245

Supplementary Protection Certificates for EDURANT PED

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	122012000038	Germany		PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
1419152	122012000035	Germany		PRODUCT NAME: RILPIVIRIN UND DESSEN STEREOCHEMISCH ISOMERE FORMEN, SOWIE DESSEN PHARMAZEUTISCH UNBEDENKLICHE ADDITIONSSALZE, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1632232	300852	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623

EDURANT PED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EDURANT (Rilpivirine)

Introduction to EDURANT

EDURANT (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the treatment of HIV-1 infection. It is part of the antiretroviral therapy regimen and has been a significant player in the HIV drugs market.

Current Market Status

The global HIV drugs market, within which EDURANT operates, was valued at $32.8 billion in 2022 and is projected to reach $51.1 billion by 2032, growing at a CAGR of 4.5% from 2023 to 2032[4].

Expansion into Pediatric Indications

Recently, Janssen Pharmaceutical Companies of Johnson & Johnson submitted a supplemental New Drug Application (sNDA) to the U.S. FDA and a parallel Marketing Authorization application to the European Medicines Agency (EMA) to expand the indication of EDURANT to include the treatment of HIV-1 infection in children weighing 10 kg or more. This expansion is a critical step in addressing the global HIV epidemic across all age groups[1].

Market Segmentation

The HIV drugs market is segmented by distribution channels, with hospital pharmacies currently dominating the market due to high sales and a high number of HIV patients seeking treatment in hospitals. However, the online pharmacies segment is expected to witness the highest CAGR during the forecast period, driven by convenience, improvements in logistics, and ease of payment options[4].

Regional Dynamics

North America, particularly the U.S., holds a significant share of the HIV drugs market due to the presence of major players like Johnson & Johnson, advanced healthcare facilities, and high healthcare expenditure. This region is expected to maintain its dominance during the forecast period. Asia-Pacific, however, is anticipated to grow at the highest rate, driven by a rise in HIV cases and increasing purchasing power in populous countries like China and India[4].

Competitive Landscape

The HIV drugs market is highly competitive, with several key players including AbbVie, Bristol-Myers Squibb, Gilead Sciences, Johnson & Johnson, and Merck & Co. The demand for new HIV drug options is continuously rising due to advancements in research and development, increased healthcare expenditure, and patient advocacy. Emerging markets are gaining importance as companies focus on unmet medical demands, especially in developing economies[4].

Financial Trajectory

Johnson & Johnson's overall pharmaceutical portfolio, which includes EDURANT, is expected to drive robust growth. The company aims to achieve $57 billion in operational sales by 2025, driven by market share gains and expansion into new patient populations. The power of their portfolio and pipeline is expected to enable growth, with a CAGR of 5-7% from 2025 to 2030[3].

Pipeline and Product Expansions

EDURANT, as part of Johnson & Johnson's portfolio, benefits from the company's strategy to deliver an accelerated pipeline of transformational, first-in-class, and best-in-class medicines. The company is making bold investments in key capabilities such as supply chain expansion, data science, and digital health to advance its leadership. Over 20 novel therapies and 50+ product expansions are expected through 2030, with a significant portion of these being first-in-class programs[3].

Cost Support and Accessibility

To enhance accessibility, Janssen offers various cost support programs for EDURANT, including savings options and patient assistance programs. These initiatives help reduce the financial burden on patients, making the medication more accessible, especially in regions with high unmet medical demands[5].

Regulatory and Approval Process

The recent submission for expanded pediatric indication underscores Janssen's commitment to regulatory compliance and patient needs. Approvals from regulatory bodies like the FDA and EMA are crucial for market expansion and ensuring the drug's safety and efficacy across different patient populations[1].

Challenges and Opportunities

Despite the positive outlook, the HIV drugs market faces challenges such as patent expiries, competition from generics, and fluctuations in economic factors. However, these challenges also present opportunities for innovation and expansion into new markets. The rise in research and development activities and the increasing focus on emerging markets are expected to drive growth and innovation in the sector[3][4].

Key Takeaways

• Market Growth: The global HIV drugs market is projected to grow at a CAGR of 4.5% from 2023 to 2032.
• Pediatric Expansion: EDURANT is seeking expanded indication for children weighing 10 kg or more.
• Regional Dominance: North America currently dominates the market, but Asia-Pacific is expected to grow at the highest rate.
• Competitive Landscape: The market is highly competitive with major players focusing on innovation and emerging markets.
• Financial Trajectory: Johnson & Johnson aims for $57 billion in operational sales by 2025, driven by its robust portfolio and pipeline.

FAQs

1. What is EDURANT used for? EDURANT (rilpivirine) is used in the treatment of HIV-1 infection as part of an antiretroviral therapy regimen.

2. What is the current market size of the HIV drugs market? The global HIV drugs market was valued at $32.8 billion in 2022 and is projected to reach $51.1 billion by 2032[4].

3. Which region is expected to grow the fastest in the HIV drugs market? Asia-Pacific is anticipated to grow at the highest rate during the forecast period due to a rise in HIV cases and increasing purchasing power in populous countries like China and India[4].

4. What is the significance of the recent sNDA submission for EDURANT? The submission seeks to expand the indication of EDURANT to include the treatment of HIV-1 infection in children weighing 10 kg or more, marking a significant step in addressing the global HIV epidemic across all age groups[1].

5. How does Johnson & Johnson support the accessibility of EDURANT? Johnson & Johnson offers various cost support programs, including savings options and patient assistance programs, to make EDURANT more accessible to patients[5].

Cited Sources

1. Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT - Janssen Pharmaceutical Companies of Johnson & Johnson.
2. Innovative Medicine Presentation - Johnson & Johnson.
3. Innovative Medicine Presentation Update - Johnson & Johnson.
4. HIV Drugs Market Size, Share and Growth Analysis | Report, 2032 - Allied Market Research.
5. Paying for EDURANT® - Cost Support - Janssen CarePath - Janssen CarePath.