Risdiplam - Generic Drug Details

What are the generic drug sources for risdiplam and what is the scope of patent protection?

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

Risdiplam has one hundred and fourteen patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for risdiplam

International Patents:	114
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	18
Patent Applications:	69
What excipients (inactive ingredients) are in risdiplam?	risdiplam excipients list
DailyMed Link:	risdiplam at DailyMed

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

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 risdiplam

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

Sponsor	Phase
Hoffmann-La Roche	Phase 4
Clinic for Special Children	Phase 4
Biohaven Pharmaceuticals, Inc.	Phase 3

See all risdiplam clinical trials

Pharmacology for risdiplam

Drug Class	Survival of Motor Neuron 2 Splicing Modifier
Mechanism of Action	Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Survival of Motor Neuron 2 Splicing Modifiers
Physiological Effect	Increased Protein Synthesis

Anatomical Therapeutic Chemical (ATC) Classes for risdiplam

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 risdiplam

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
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535-001	Aug 7, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for risdiplam

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

International Patents for risdiplam

Country	Patent Number	Title	Estimated Expiration
Canada	2863874	COMPOSES DESTINES AU TRAITEMENT DE L'AMYOTROPHIE SPINALE (COMPOUNDS FOR TREATING SPINAL MUSCULAR ATROPHY)
Morocco	35920	Composés destinés au traitement de l'amyotrophie spinale
Norway	2021035

Supplementary Protection Certificates for risdiplam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3143025	C03143025/01	Switzerland		PRODUCT NAME: RISDIPLAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67251 06.05.2021
3143025	C202130047	Spain		PRODUCT NAME: RISDIPLAM O SUS SALES FARMACEUTICAMENTE ACEPTABLES; NATIONAL AUTHORISATION NUMBER: EU/1/21/1531; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1531; DATE OF FIRST AUTHORISATION IN EEA: 20210326
3143025	CR 2021 00037	Denmark		PRODUCT NAME: RISDIPLAM ELLER FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/21/1531 20210329