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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 October 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

International Patents:	199
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	14
Patent Applications:	1,153
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:

7,125,879*PED

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.

This potential generic entry date is based on patent 7,125,879.

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	7,125,879*PED				Y
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	8,101,629
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	7,067,522
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	7,638,522

International Patents for EDURANT

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

Country	Patent Number	Title	Estimated Expiration
Canada	2577288	CHLORHYDRATE DE 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYL-PHENYL]AMINO]-2-PYRIMIDINYL]AMINO]BENZONITRILE (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL]AMINO]BENZONITRILE)
South Korea	100855258
Austria	517891
Japan	2012051915	COMBINATION OF PYRIMIDINE-CONTAINING NNRTI WITH RT INHIBITOR
Nicaragua	200700069	FUMARATO DE 4-((4-((4- (2-CIANOETENIL)-2,6-DIMETILFENIL)AMINO)-2- PIRIMIDINIL) AMINO) BENZONITRILO
South Korea	100969273

Supplementary Protection Certificates for EDURANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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)
1663240	PA2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
1632232	93384	Luxembourg		PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
1663240	122016000109	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152	CA 2012 00021	Denmark
1632232	93385	Luxembourg		PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE

EDURANT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EDURANT

Introduction to EDURANT

EDURANT (rilpivirine) is an antiretroviral medication developed by Janssen Pharmaceutical Companies of Johnson & Johnson, used in the treatment of HIV-1 infection. Here, we will delve into the market dynamics and financial trajectory of EDURANT, highlighting its current status, future prospects, and the broader context of the HIV drugs market.

Current Market Position

EDURANT is part of a robust portfolio of HIV treatments offered by Janssen. The drug has been approved for use in adults and is now being considered for expanded indications, including pediatric use. Janssen has 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 include children weighing 10 kg or more in the treatment indication[1].

Global HIV Drugs Market

The global HIV drugs market is significant and growing. In 2022, the market size was valued at $32.8 billion and is projected to reach $51.1 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 4.5% from 2023 to 2032. This growth is driven by increasing demand for HIV drugs, government initiatives to raise awareness about HIV diagnosis and management, and a rise in HIV cases globally[4].

Regional Market Share

North America dominates the HIV drugs market, driven by the presence of major players like AbbVie, Bristol-Myers Squibb, Gilead Sciences, Johnson & Johnson, and Merck & Co. The region's advanced healthcare facilities, high healthcare expenditure, and sophisticated reimbursement structures contribute to its leading position. However, the Asia-Pacific region is expected to grow at the highest rate due to its large population base and increasing purchasing power[4].

Competitive Landscape

The HIV drugs market is highly competitive, with several key players vying for market share. EDURANT competes with other antiretroviral therapies, including those from Gilead Sciences, AbbVie, and Bristol-Myers Squibb. The demand for new HIV drug options is on the rise due to ongoing research and development, increased healthcare expenditure, and patient advocacy[4].

Financial Performance and Projections

Johnson & Johnson's pharmaceutical segment, which includes EDURANT, is expected to drive significant growth. The company aims to achieve $57 billion in operational sales by 2025, with a CAGR of 5-7% from 2025 to 2030. This growth will be fueled by market share gains, expansion into new patient populations, and the launch of novel therapies and product expansions. EDURANT, as part of this portfolio, is expected to contribute to these financial projections, especially with its potential expanded indication for pediatric use[2][3].

Cost Support and Accessibility

To enhance accessibility, Janssen offers cost support programs for EDURANT. These programs include savings options and patient assistance initiatives to help manage the medication costs, making it more affordable for patients[5].

Innovation and Pipeline

Janssen is committed to innovation, with a pipeline that includes several novel therapies and product expansions. The company has secured multiple breakthrough and fast-track designations and has formed over 80 new partnerships since 2021. This innovative ecosystem positions EDURANT and other Janssen products for continued market relevance and growth[2][3].

Regulatory and Expansion Efforts

The recent submission for expanded pediatric indication is a significant step forward for EDURANT. If approved, this expansion will mark another milestone in Janssen's efforts to address the global HIV epidemic across all age groups. This move aligns with the company's strategy to deliver innovative medicines to broader patient populations[1].

Challenges and Opportunities

Despite the positive outlook, the HIV drugs market faces challenges such as patent expiries and the entry of biosimilars. For instance, key brands like STELARA, XARELTO, and IMBRUVICA are set to face patent expiries, which could impact market dynamics. However, Janssen's diversified portfolio and ongoing innovation efforts are positioned to mitigate these risks and capitalize on emerging opportunities[2][3].

Key Takeaways

• Market Growth: The global HIV drugs market is growing, driven by increasing demand and government initiatives.
• Regional Dominance: North America leads the market, but Asia-Pacific is expected to grow rapidly.
• Competitive Landscape: EDURANT competes in a highly competitive market with several key players.
• Financial Projections: Johnson & Johnson's pharmaceutical segment, including EDURANT, is expected to achieve significant growth by 2025 and beyond.
• Innovation: Janssen's commitment to innovation and pipeline expansions supports the long-term viability of EDURANT.
• Accessibility: Cost support programs enhance the accessibility of EDURANT.

FAQs

1. What is EDURANT used for?

   • EDURANT (rilpivirine) is used in the treatment of HIV-1 infection.

2. Who is the manufacturer of EDURANT?

   • EDURANT is manufactured by Janssen Pharmaceutical Companies of Johnson & Johnson.

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

   • The global HIV drugs market was valued at $32.8 billion in 2022.

4. What is the projected growth rate of the global HIV drugs market?

   • The market is expected to grow at a CAGR of 4.5% from 2023 to 2032.

5. What are the key regions driving the growth of the HIV drugs market?

   • North America currently dominates the market, but the Asia-Pacific region is expected to grow at the highest rate.

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.