Risdiplam - Generic Drug Details

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

Risdiplam is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Risdiplam has ninety-three patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for risdiplam

International Patents:	93
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	15
Patent Applications:	71
What excipients (inactive ingredients) are in risdiplam?	risdiplam excipients list
DailyMed Link:	risdiplam at DailyMed

Recent Clinical Trials for risdiplam

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

Sponsor	Phase
Clinic for Special Children	Phase 4
Biohaven Pharmaceuticals, Inc.	Phase 3
Scholar Rock, Inc.	Phase 3

See all risdiplam clinical trials

US Patents and Regulatory Information for risdiplam

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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
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				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

EU/EMA Drug Approvals for risdiplam

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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 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.,	Authorised	no	no	yes	2021-03-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for risdiplam

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Country	Patent Number	Title	Estimated Expiration
Denmark	2812004		See Plans and Pricing
Mexico	371050	COMPUESTOS PARA TRATAR ATROFIA MUSCULAR ESPINAL. (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY.)	See Plans and Pricing
Poland	3143025		See Plans and Pricing
Philippines	12014501786	COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for risdiplam

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143025	2021C/537	Belgium	See Plans and Pricing	PRODUCT NAME: RISDIPLAM OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1531 20210329
3143025	301128	Netherlands	See Plans and Pricing	PRODUCT NAME: RISDIPLAM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1531 20210329
3143025	CA 2021 00037	Denmark	See Plans and Pricing	PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329
3143025	CR 2021 00037	Denmark	See Plans and Pricing	PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.