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 eighty-one patent family members in twenty-four 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:	81
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 Loss of Exclusivity (LOE) Date for AMONDYS 45

Generic Entry Date for AMONDYS 45^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 213026 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

Drug Class	Antisense Oligonucleotide
Physiological Effect	Increased Protein Synthesis

Anatomical Therapeutic Chemical (ATC) Classes for AMONDYS 45

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

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 ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Antisense molecules and methods for treating pathologies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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

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: ⤷ Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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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	⤷ Try a Trial	⤷ Try a Trial
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021	⤷ Try a Trial	⤷ Try a Trial
>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: ⤷ Try a Trial

Patent: 16202924
Estimated Expiration: ⤷ Try a Trial

Patent: 18202105
Estimated Expiration: ⤷ Try a Trial

Patent: 20260498
Estimated Expiration: ⤷ Try a Trial

Patent: 23203103
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2012011195
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 80563
Estimated Expiration: ⤷ Try a Trial

China

Patent: 3003430
Estimated Expiration: ⤷ Try a Trial

Patent: 5838714
Estimated Expiration: ⤷ Try a Trial

Croatia

Patent: 0181824
Estimated Expiration: ⤷ Try a Trial

Cyprus

Patent: 21198
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 99249
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 99249
Estimated Expiration: ⤷ Try a Trial

Patent: 31603
Estimated Expiration: ⤷ Try a Trial

Hungary

Patent: 40445
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 9753
Estimated Expiration: ⤷ Try a Trial

Patent: 5707
Estimated Expiration: ⤷ Try a Trial

Patent: 4525
Estimated Expiration: ⤷ Try a Trial

Patent: 6947
Estimated Expiration: ⤷ Try a Trial

Patent: 7299
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 63678
Estimated Expiration: ⤷ Try a Trial

Patent: 94393
Estimated Expiration: ⤷ Try a Trial

Patent: 25449
Estimated Expiration: ⤷ Try a Trial

Patent: 36830
Estimated Expiration: ⤷ Try a Trial

Patent: 13510561
Estimated Expiration: ⤷ Try a Trial

Patent: 16198105
Estimated Expiration: ⤷ Try a Trial

Patent: 18082714
Estimated Expiration: ⤷ Try a Trial

Patent: 19141073
Estimated Expiration: ⤷ Try a Trial

Patent: 22001053
Estimated Expiration: ⤷ Try a Trial

Lithuania

Patent: 99249
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 6359
Estimated Expiration: ⤷ Try a Trial

Patent: 6534
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 99249
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 99249
Estimated Expiration: ⤷ Try a Trial

Serbia

Patent: 079
Estimated Expiration: ⤷ Try a Trial

Slovenia

Patent: 99249
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1958491
Estimated Expiration: ⤷ Try a Trial

Patent: 2000762
Estimated Expiration: ⤷ Try a Trial

Patent: 2113306
Estimated Expiration: ⤷ Try a Trial

Patent: 2239374
Estimated Expiration: ⤷ Try a Trial

Patent: 2366851
Estimated Expiration: ⤷ Try a Trial

Patent: 2487132
Estimated Expiration: ⤷ Try a Trial

Patent: 130084595
Estimated Expiration: ⤷ Try a Trial

Patent: 180004745
Estimated Expiration: ⤷ Try a Trial

Patent: 190084360
Estimated Expiration: ⤷ Try a Trial

Patent: 200055161
Estimated Expiration: ⤷ Try a Trial

Patent: 210041130
Estimated Expiration: ⤷ Try a Trial

Patent: 220031125
Estimated Expiration: ⤷ Try a Trial

Patent: 230010814
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 93459
Estimated Expiration: ⤷ Try a Trial

Turkey

Patent: 1816523
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Australia	5752601		⤷ Try a Trial
South Korea	20190084360	안티센스 분자 및 이를 이용한 질환 치료방법 (Antisense Molecules and Methods for Treating Pathologies)	⤷ Try a Trial
Japan	6936830		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2008036127		⤷ Try a Trial
Canada	2571593	TECHNIQUE ET COMPOSE ANTIBACTERIEN ANTISENS (ANTISENSE ANTIBACTERIAL METHOD AND COMPOUND)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for AMONDYS 45

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMONDYS 45

Pharmacology for AMONDYS 45

Anatomical Therapeutic Chemical (ATC) Classes for AMONDYS 45

Patents protecting AMONDYS 45

FDA Regulatory Exclusivity protecting AMONDYS 45

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

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMONDYS 45