Viewing data from:

EVRYSDI

NDA

RISDIPLAM | N213535 | GENENTECH INC

1 strength7 unique patents3 unique exclusivities

Patent Timeline

7 unique patents, 3 exclusivities by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Feb. 8, 2033

May. 11, 2035

Oct. 4, 2038

Jan. 25, 2036

Nov. 8, 2036

Apr. 15, 2041

Oct. 1, 2038

M-270

Oct. 3, 2026

ODE-334

Aug. 7, 2027

ODE-400

May. 27, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
GENENTECH, INC. et al v. SUN PHARMACEUTICAL INDUSTRIES, LTD et al 2:2025cv17100 1 patentANDA 219848, 219902risdiplam	D.N.J.	2025-10-31	Active	—
GENENTECH, INC. et al v. ZYDUS LIFESCIENCES GLOBAL FZE et al 2:2025cv01521 1 patentANDA 219902risdiplam	D.N.J.	2025-02-27	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1 NCT07070999	Phase 1/2	Recruiting	Gemma Biotherapeutics	22	2026-01-06 → 2029-04
A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy NCT05808764	Phase 2	Completed	Hoffmann-La Roche	11	2024-04-26 → 2026-05-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Evrysdi (2023)

Total Spending

$132.4M

Total Claims

4,833

Beneficiaries

424

Avg Cost/Unit

$161.72

Spending Trend

$15.2M(2020)→$92.0M(2021)→$120.8M(2022)→$132.4M(2023)

YoY Change:+6.9%

5yr CAGR:+3.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

ALP PHARM BEIJING CO LTDRISDIPLAM

DMF 368972022

TAPI NL BVRISDIPLAM

DMF 392552024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRISDIPLAM

DMF 396022024

NATCO PHARMA LTDRISDIPLAM

DMF 397552024

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDRISDIPLAM

DMF 404722024

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDRISDIPLAM INTERMEDIATE (CAS NO.: 2133298-74-3)

DMF 432442025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Feb 20, 2026	SUPPL -17	View Letter (PDF)
Jan 22, 2026	SUPPL -15	View Letter (PDF)
Feb 12, 2025	SUPPL -14	View Letter (PDF)
Sep 19, 2024	SUPPL -13	View Letter (PDF)
Mar 1, 2024	SUPPL -12	View Letter (PDF)
Oct 5, 2023	SUPPL -11	View Letter (PDF)
Mar 27, 2023	SUPPL -8	View Letter (PDF)
Sep 22, 2022	SUPPL -6	View Letter (PDF)
May 31, 2022	SUPPL -5	View Letter (PDF)
May 31, 2022	SUPPL -3	View Letter (PDF)
May 4, 2021	SUPPL -1	View Letter (PDF)
Aug 3, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.75MG/ML

RLD

7 patents3 exclusivities▴

FOR SOLUTION;ORAL | Approved: Aug 7, 2020

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9586955	Feb 8, 2033	—	Yes	Yes	—	—
9969754	May 11, 2035	—	Yes	Yes		—
11534444	Oct 4, 2038	—	—	—		—
11827646	Jan 25, 2036	—	—	—		—
11938136	Nov 8, 2036	—	—	Yes	—	—
12122789	Apr 15, 2041	—	Yes	Yes	—	—
12350273	Oct 1, 2038	—	—	—		—

Exclusivities (3)

Code	Date	Status
M-270	Oct 3, 2026	< 1 year
ODE-334	Aug 7, 2027	Active
ODE-400	May 27, 2029	Active