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-six patent family members in forty-six 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

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:	226
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

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.

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 PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		DISCN	Yes	No	11,065,198		Y

Expired US Patents for EDURANT PED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024	7,125,879

International Patents for EDURANT PED

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1419152	DERIVES DE PYRIMIDINES INHIBITEURS DE VIH (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Croatia	P20192051	DERIVATI PIRIMIDINA KOJI INHIBIRAJU HIV (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Canada	2537095	COMBINAISONS D'UNE PYRIMIDINE RENFERMANT NNRTI AVEC DES INHIBITEURS DE RT (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS)
Australia	2005279157	Furamate of 4-[[4-[[4- (2-cyanoethenyl) -2,6-dimethylphenyl]amino)-2-pyrimidinyl)amino]benzonitrile
Denmark	1663240
Slovenia	1789139

Supplementary Protection Certificates for EDURANT PED

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
1419152	SPC/GB12/022	United Kingdom		PRODUCT NAME: RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF.; REGISTERED: UK EU/1/11/736/001 20111128
1632232	300853	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	132016000024751	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E EMTRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
2932970	1890039-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
1663240	PA2016044	Lithuania		PRODUCT NAME: RILPIVIRINAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621

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.

Last updated: 2024-12-18