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Last Updated: December 22, 2024

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EVRYSDI Drug Patent Profile


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

Evrysdi is a drug marketed by Genentech Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty patent family members in thirty-nine countries.

The generic ingredient in EVRYSDI is risdiplam. One supplier is listed for this compound. Additional details are available on the risdiplam profile page.

DrugPatentWatch® Generic Entry Outlook for Evrysdi

Evrysdi was eligible for patent challenges on August 7, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 11, 2035. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for EVRYSDI
International Patents:130
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 3
Patent Applications: 41
Drug Prices: Drug price information for EVRYSDI
What excipients (inactive ingredients) are in EVRYSDI?EVRYSDI excipients list
DailyMed Link:EVRYSDI at DailyMed
Drug patent expirations by year for EVRYSDI
Drug Prices for EVRYSDI

See drug prices for EVRYSDI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EVRYSDI
Generic Entry Date for EVRYSDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SOLUTION;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 EVRYSDI

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

SponsorPhase
Hoffmann-La RochePhase 4
Genentech, Inc.Phase 4
Hoffmann-La RochePhase 1

See all EVRYSDI clinical trials

Paragraph IV (Patent) Challenges for EVRYSDI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EVRYSDI For Oral Solution risdiplam 0.75 mg/mL 213535 2 2024-08-07

US Patents and Regulatory Information for EVRYSDI

EVRYSDI is protected by five US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EVRYSDI is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Genentech Inc EVRYSDI risdiplam FOR SOLUTION;ORAL 213535-001 Aug 7, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for EVRYSDI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Roche Registration GmbH  Evrysdi risdiplam EMEA/H/C/005145
Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. 
Authorised no no no 2021-03-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for EVRYSDI

When does loss-of-exclusivity occur for EVRYSDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0442
Patent: DERIVADOS DE PIRIDO[1,2-A]PIRIMIDIN-4-ONA PARA TRATAR ATROFIA MUSCULAR ESPINAL
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 15261046
Patent: Compounds for treating spinal muscular atrophy
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2016026205
Patent: Moduladores de entrançamento de gene smn2, seu uso e seu processo de preparação, e composições farmacêuticas
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 48561
Patent: COMPOSES POUR LE TRAITEMENT D'UNE AMYOTROPHIE SPINALE (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 16002836
Patent: Compuestos derivados de pirido pirimidin con actividad moduladora del empalme genico de smn2; composicion farmaceutica y uso en el tratamiento de la atrofia muscular espinal (ame).
Estimated Expiration: ⤷  Subscribe

China

Patent: 6459092
Patent: 用于治疗脊髓性肌萎缩的化合物 (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 160518
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0192159
Estimated Expiration: ⤷  Subscribe

Patent: 0230637
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 43025
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 5068
Patent: СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Patent: 1692280
Patent: СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ
Estimated Expiration: ⤷  Subscribe

Patent: 2090486
Patent: СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ СПИНАЛЬНОЙ МЫШЕЧНОЙ АТРОФИИ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 43025
Patent: COMPOSÉS DESTINÉS À TRAITER L'AMYOTROPHIE SPINALE (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Patent: 63296
Patent: PROCÉDÉ POUR LA PRÉPARATION DE COMPOSÉS UTILES À TRAITER L'AMYOTROPHIE SPINALE (PROCESS FOR THE PREPARATION OF COMPOUNDS USEFUL FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Patent: 41772
Patent: PROCÉDÉ DE PRÉPARATION DE COMPOSÉS UTILES POUR LE TRAITEMENT DE L'AMYOTROPHIE SPINALE (PROCESS FOR THE PREPARATION OF COMPOUNDS USEFUL FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

France

Patent: C1039
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 46491
Estimated Expiration: ⤷  Subscribe

Patent: 100037
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 8653
Patent: תרכובות לטיפול בניוון שרירים שידרתי (Compounds for treating spinal muscular atrophy)
Estimated Expiration: ⤷  Subscribe

Patent: 0027
Patent: תרכובות לטיפול בניוון שרירים שידרתי (Compounds for treating spinal muscular atrophy)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 36173
Estimated Expiration: ⤷  Subscribe

Patent: 17515863
Patent: 脊髄性筋萎縮症を処置するための化合物
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 2021010
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 4284
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 1050
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL. (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY.)
Estimated Expiration: ⤷  Subscribe

Patent: 16014547
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL. (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY.)
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 995
Patent: Composés destinés à traiter l'amyotrophie spinale
Estimated Expiration: ⤷  Subscribe

Patent: 988
Patent: PROCÉDÉ POUR LA PRÉPARATION DE COMPOSÉS UTILES À TRAITER L'AMYOTROPHIE SPINALE
Estimated Expiration: ⤷  Subscribe

Netherlands

Patent: 1128
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 5008
Patent: Compounds for treating spinal muscular atrophy
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 21035
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 170128
Patent: COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL
Estimated Expiration: ⤷  Subscribe

Philippines

Patent: 016502081
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 43025
Estimated Expiration: ⤷  Subscribe

Patent: 63296
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 43025
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 718
Patent: JEDINJENJA ZA LEČENJE SPINALNE MIŠIĆNE ATROFIJE (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201609497T
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 43025
Estimated Expiration: ⤷  Subscribe

Patent: 63296
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1607026
Patent: COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2213740
Estimated Expiration: ⤷  Subscribe

Patent: 2256013
Estimated Expiration: ⤷  Subscribe

Patent: 170003687
Patent: 척수성 근위축증을 치료하기 위한 화합물 (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Patent: 210014219
Patent: 척수성 근위축증을 치료하기 위한 화합물 (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 61423
Estimated Expiration: ⤷  Subscribe

Patent: 49660
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 67239
Estimated Expiration: ⤷  Subscribe

Patent: 1609738
Patent: Compounds for treating spinal muscular atrophy
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 9670
Patent: СПОЛУКИ ДЛЯ ЛІКУВАННЯ СПІНАЛЬНОЇ М'ЯЗОВОЇ АТРОФІЇ (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Estimated Expiration: ⤷  Subscribe

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EVRYSDI around the world.

Country Patent Number Title Estimated Expiration
Australia 2015261046 Compounds for treating spinal muscular atrophy ⤷  Subscribe
South Korea 102341596 ⤷  Subscribe
Argentina 092794 COMPUESTOS PARA TRATAR LA ATROFIA MUSCULAR ESPINAL ⤷  Subscribe
Slovenia 3143025 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EVRYSDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3143025 CA 2021 00037 Denmark ⤷  Subscribe PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329
3143025 SPC/GB21/050 United Kingdom ⤷  Subscribe PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1531(FOR NI) 20210329; UK FURTHER MA ON IPSUM 20210329
3143025 122021000051 Germany ⤷  Subscribe PRODUCT NAME: RISDIPLAM ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1531 20210326
3143025 301128 Netherlands ⤷  Subscribe PRODUCT NAME: RISDIPLAM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1531 20210329
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

EVRYSDI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Evrysdi

Introduction to Evrysdi

Evrysdi (risdiplam) is a groundbreaking oral small molecule approved by the U.S. FDA in 2020 for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. Developed by PTC Therapeutics and marketed by Roche, Evrysdi has quickly become a dominant force in the SMA treatment market.

Mechanism and Clinical Impact

Evrysdi works as a survival motor neuron 2 (SMN2) splicing modifier, enhancing the production of the SMN protein, which is crucial for motor neuron function. Clinical trials have shown significant efficacy in maintaining and improving motor function in patients with SMA, making it a preferred treatment option for many[5].

Market Dominance

In a notable shift, Evrysdi has surpassed the sales of other SMA treatments, including the antisense oligonucleotide Spinraza and the gene therapy Zolgensma. This indicates that traditional small molecule therapies still hold significant market value despite the emergence of newer modalities. The collective sales of these SMA drugs reached a new high of $1.3 billion in the second quarter of 2024, exceeding the $1.15 billion total from the third quarter of 2023[1].

Sales Performance

Evrysdi's sales have been robust, with full-year 2023 sales reported at approximately CHF 1,419 million (around $1.4 billion), resulting in royalty revenue of $168.9 million for PTC Therapeutics. This represents a significant increase from the $113.5 million in royalty revenue for 2022. Additionally, PTC recorded a sales milestone of $100 million for achieving $1.5 billion in worldwide annual net sales from Evrysdi in the fourth quarter of 2023[3].

Royalty Monetization

In a strategic financial move, PTC Therapeutics sold up to $1.5 billion of its Evrysdi royalty stream to Royalty Pharma plc. This transaction included an upfront payment of $1.0 billion, with options for additional payments up to $500 million. This deal is expected to enhance PTC's financial stability, allowing the company to pay off debt and fuel its development pipeline[2][4].

Financial Projections

Royalty Pharma's acquisition of the Evrysdi royalty is projected to significantly contribute to its long-term growth. Evrysdi is expected to become one of the top four portfolio royalties for Royalty Pharma by 2025, with Adjusted Cash Receipts contributions exceeding $200 million based on consensus sales estimates. This transaction highlights the financial viability and market potential of Evrysdi[4].

Patient Impact and Clinical Efficacy

Clinical trials and real-world data have shown that Evrysdi effectively maintains and improves motor function in SMA patients. Patients like Angela, who lives with Type 2 SMA, have reported significant benefits in daily activities, such as brushing teeth and applying makeup, which are crucial for maintaining independence. Neurologists, like Dr. Shadé Moody, emphasize the importance of monitoring patient progress and managing potential side effects to ensure optimal treatment outcomes[5].

Market Competition

Despite the dominance of Evrysdi, the SMA market remains competitive with other treatments like Spinraza and Zolgensma. However, Evrysdi's oral administration and convenience have made it a preferred choice for many patients and healthcare providers. The market dynamics suggest that traditional small molecule therapies can still outperform newer modalities in terms of sales and patient preference[1].

Financial Growth and Diversification

The financial performance of Evrysdi has contributed significantly to the growth of both PTC Therapeutics and Royalty Pharma. For PTC, the royalty revenue from Evrysdi has been a key driver of its 34% year-over-year revenue growth in 2023. For Royalty Pharma, the acquisition of Evrysdi royalties is part of a broader strategy to enhance long-term growth and diversify its royalty portfolio[3][4].

Future Outlook

Given its strong sales performance and clinical efficacy, Evrysdi is poised to continue dominating the SMA market. The drug's ability to treat a wide range of SMA patients, from pediatric to adult, further solidifies its market position. As the SMA treatment landscape evolves, Evrysdi's convenience, efficacy, and financial performance make it a cornerstone in the therapeutic options available.

Key Takeaways

  • Market Dominance: Evrysdi has surpassed the sales of other SMA treatments, including Spinraza and Zolgensma.
  • Financial Performance: Full-year 2023 sales of Evrysdi reached approximately CHF 1,419 million, with significant royalty revenue for PTC Therapeutics.
  • Royalty Monetization: PTC Therapeutics sold up to $1.5 billion of its Evrysdi royalty stream to Royalty Pharma plc.
  • Clinical Efficacy: Evrysdi effectively maintains and improves motor function in SMA patients.
  • Future Outlook: Evrysdi is expected to continue dominating the SMA market due to its convenience, efficacy, and strong financial performance.

FAQs

Q: What is Evrysdi and how does it work?

A: Evrysdi (risdiplam) is an oral small molecule that works as a survival motor neuron 2 (SMN2) splicing modifier to enhance the production of the SMN protein, crucial for motor neuron function.

Q: How has Evrysdi performed in the market?

A: Evrysdi has surpassed the sales of other SMA treatments like Spinraza and Zolgensma, with collective SMA drug sales reaching a new high of $1.3 billion in the second quarter of 2024.

Q: What was the financial impact of the royalty sale to Royalty Pharma?

A: The sale of up to $1.5 billion of Evrysdi's royalty stream to Royalty Pharma provided significant upfront capital to PTC Therapeutics, helping to pay off debt and fund its development pipeline.

Q: How does Evrysdi compare to other SMA treatments?

A: Evrysdi's oral administration and convenience have made it a preferred choice over other treatments like Spinraza and Zolgensma, despite the latter being newer modalities.

Q: What are the future prospects for Evrysdi in the SMA market?

A: Given its strong sales performance, clinical efficacy, and financial projections, Evrysdi is expected to continue dominating the SMA market, treating a wide range of patients from pediatric to adult.

Sources:

  1. Biocentury: "Small molecule Evrysdi overtakes new modalities to dominate SMA market"
  2. BioWorld: "PTC sells Evrysdi royalties in deal potentially worth $1.5B"
  3. PTC Therapeutics: "PTC Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results"
  4. Royalty Pharma: "Royalty Pharma Announces Agreement to Purchase up to $1.5 Billion of PTC Therapeutics’ Royalty on Evrysdi"
  5. Evrysdi-HCP: "Later-Onset SMA Efficacy Results in Clinical Trials & Studies"

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