CASIMERSEN - Generic Drug Details

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What are the generic drug sources for casimersen and what is the scope of freedom to operate?

Casimersen is the generic ingredient in one branded drug marketed by Sarepta Theraps Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Casimersen has eighty-seven patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for CASIMERSEN

International Patents:	87
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
What excipients (inactive ingredients) are in CASIMERSEN?	CASIMERSEN excipients list
DailyMed Link:	CASIMERSEN at DailyMed

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

Generic Entry Date for CASIMERSEN^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for CASIMERSEN

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

Sponsor	Phase
Kevin Flanigan	Phase 2
Sarepta Therapeutics, Inc.	Phase 2
Sarepta Therapeutics	Phase 3

See all CASIMERSEN clinical trials

Pharmacology for CASIMERSEN

Drug Class	Antisense Oligonucleotide
Physiological Effect	Increased Protein Synthesis

Anatomical Therapeutic Chemical (ATC) Classes for CASIMERSEN

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 CASIMERSEN

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sarepta Theraps Inc	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 CASIMERSEN

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

International Patents for CASIMERSEN

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3228711	OLIGONUCLÉOTIDES ANTISENS PERMETTANT D'INDUIRE UN SAUT D'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF)	⤷ Sign Up
Japan	6525449		⤷ Sign Up
European Patent Office	2500430	Oligonucléotides antisens permettant d'induire un saut d'exon et leurs procédés d'utilisation (Antisense oligonucleotides for inducing exon skipping and methods of use thereof)	⤷ Sign Up
Portugal	2499249		⤷ Sign Up
South Korea	20190084360	안티센스 분자 및 이를 이용한 질환 치료방법 (Antisense Molecules and Methods for Treating Pathologies)	⤷ Sign Up
Israel	255707	אוליגונוקלאוטידי אנטיסנס לגרימת דילוג אקסון בגן דיסטרופין (Antisense oligonucleotides for inducing exon skipping in the dystrophin gene)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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