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NDA

RISDIPLAM | N219285 | GENENTECH INC

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)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

Apr. 15, 2041

Oct. 1, 2038

M-270

Oct. 3, 2026

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
GENENTECH, INC. et al v. ZENARA PHARMA PRIVATE LIMITED et al 2:2026cv06555 6 patentsANDA 221422risdiplam	D.N.J.	2026-06-04	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

3 letters from Drugs@FDA

Date	Submission	Document
Feb 20, 2026	SUPPL -2	View Letter (PDF)
Jan 22, 2026	SUPPL -1	View Letter (PDF)
Feb 12, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

RLD

6 patents1 exclusivity▴

TABLET;ORAL | Approved: Feb 11, 2025

Patents (6)

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	—	—	—		—
12122789	Apr 15, 2041	—	Yes	Yes	—	—
12350273	Oct 1, 2038	—	—	—		—

Exclusivities (1)

Code	Date	Status
M-270	Oct 3, 2026	< 1 year