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Last Updated: June 28, 2022

AMONDYS 45 Drug Patent Profile


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When do Amondys 45 patents expire, and what generic alternatives are available?

Amondys 45 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There are six patents protecting this drug.

This drug has seventy-five patent family members in twenty-three countries.

The generic ingredient in AMONDYS 45 is casimersen. One supplier is listed for this compound. Additional details are available on the casimersen profile page.

DrugPatentWatch® Generic Entry Outlook for Amondys 45

Amondys 45 will be eligible for patent challenges on February 25, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 12, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AMONDYS 45
International Patents:75
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in AMONDYS 45?AMONDYS 45 excipients list
DailyMed Link:AMONDYS 45 at DailyMed
Drug patent expirations by year for AMONDYS 45
DrugPatentWatch® Estimated Generic Entry Opportunity Date for AMONDYS 45
Generic Entry Date for AMONDYS 45*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*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.

Pharmacology for AMONDYS 45

US Patents and Regulatory Information for AMONDYS 45

AMONDYS 45 is protected by eight US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMONDYS 45 is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting AMONDYS 45

Antisense molecules and methods for treating pathologies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense molecules and methods for treating pathologies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING BY RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION

Antisense molecules and methods for treating pathologies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense molecules and methods for treating pathologies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING

Antisense molecules and methods for treating pathologies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING BY RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING BY INDUCING EXON-SKIPPING OF EXON 45

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING

FDA Regulatory Exclusivity protecting AMONDYS 45

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AMONDYS 45

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc AMONDYS 45 casimersen SOLUTION;INTRAVENOUS 213026-001 Feb 25, 2021 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AMONDYS 45

When does loss-of-exclusivity occur for AMONDYS 45?

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

Australia

Patent: 10317599
Estimated Expiration: See Plans and Pricing

Patent: 16202924
Estimated Expiration: See Plans and Pricing

Patent: 18202105
Estimated Expiration: See Plans and Pricing

Patent: 20260498
Estimated Expiration: See Plans and Pricing

Canada

Patent: 80563
Estimated Expiration: See Plans and Pricing

China

Patent: 3003430
Estimated Expiration: See Plans and Pricing

Patent: 5838714
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0181824
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 21198
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 99249
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 99249
Estimated Expiration: See Plans and Pricing

Patent: 31603
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 40445
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9753
Estimated Expiration: See Plans and Pricing

Patent: 5707
Estimated Expiration: See Plans and Pricing

Patent: 4525
Estimated Expiration: See Plans and Pricing

Patent: 6947
Estimated Expiration: See Plans and Pricing

Japan

Patent: 63678
Estimated Expiration: See Plans and Pricing

Patent: 94393
Estimated Expiration: See Plans and Pricing

Patent: 25449
Estimated Expiration: See Plans and Pricing

Patent: 36830
Estimated Expiration: See Plans and Pricing

Patent: 13510561
Estimated Expiration: See Plans and Pricing

Patent: 16198105
Estimated Expiration: See Plans and Pricing

Patent: 18082714
Estimated Expiration: See Plans and Pricing

Patent: 19141073
Estimated Expiration: See Plans and Pricing

Patent: 22001053
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 99249
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6359
Estimated Expiration: See Plans and Pricing

Patent: 6534
Estimated Expiration: See Plans and Pricing

Poland

Patent: 99249
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 99249
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 079
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 99249
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1958491
Estimated Expiration: See Plans and Pricing

Patent: 2000762
Estimated Expiration: See Plans and Pricing

Patent: 2113306
Estimated Expiration: See Plans and Pricing

Patent: 2239374
Estimated Expiration: See Plans and Pricing

Patent: 2366851
Estimated Expiration: See Plans and Pricing

Patent: 130084595
Estimated Expiration: See Plans and Pricing

Patent: 180004745
Estimated Expiration: See Plans and Pricing

Patent: 190084360
Estimated Expiration: See Plans and Pricing

Patent: 200055161
Estimated Expiration: See Plans and Pricing

Patent: 210041130
Estimated Expiration: See Plans and Pricing

Patent: 220031125
Estimated Expiration: See Plans and Pricing

Spain

Patent: 93459
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1816523
Estimated Expiration: See Plans and Pricing

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 AMONDYS 45 around the world.

Country Patent Number Title Estimated Expiration
Australia 2007297861 See Plans and Pricing
Hong Kong 1216545 用於誘導外顯子跳躍的反義寡核苷酸及其使用方法 (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF) See Plans and Pricing
South Korea 102000762 See Plans and Pricing
Israel 264525 See Plans and Pricing
Canada 2584599 See Plans and Pricing
South Korea 20220031125 안티센스 분자 및 이를 이용한 질환 치료방법 (Antisense Molecules and Methods for Treating Pathologies) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Merck
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Dow
Medtronic
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.