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ZEJULA

NDA

NIRAPARIB TOSYLATE | N214876 | GLAXOSMITHKLINE LLC

3 strengths8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2026

2027

2028

2029

2030

2031

2032

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2035

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2038

2039

Today

Aug. 12, 2027

Mar. 27, 2031

Aug. 12, 2027

Apr. 24, 2029

Aug. 4, 2031

Mar. 27, 2038

Mar. 27, 2038

Jan. 25, 2039

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
GlaxoSmithKline LLC et al v. Natco Pharma Ltd. et al 1:2026cv00168 2 patentsANDA 221116niraparib	D. Del.	2026-02-13	Active	—
GlaxoSmithKline LLC et al v. Sun Pharmaceutical Industries Ltd. 1:2025cv01170 3 patentsANDA 220688niraparib	D. Del.	2025-09-18	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 Chain7 active DMFs

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

VALARY LAB PRIVATE LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 393532024

CHANGZHOU PHARMACEUTICAL FACTORYNIRAPARIB TOSYLATE MONOHYDRATE

DMF 394492024

CIPLA LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 408952025

DR REDDYS LABORATORIES LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 414552025

PORTON PHARMA SOLUTIONS LTDNIRAPARIB TOSYLATE MONOHYDRATE

DMF 415292025

MSN LABORATORIES PRIVATE LTDNIRAPARIB TOSYLATE

DMF 431572025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNIRAPARIB TOSYLATE

DMF 433042025

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2026	SUPPL -6	View Letter (PDF)
Jul 21, 2025	SUPPL -5	View Letter (PDF)
Jun 20, 2025	SUPPL -3	View Letter (PDF)
Jun 20, 2025	SUPPL -4	View Letter (PDF)
Apr 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 100MG BASE

RLD

8 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 26, 2023

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8071579	Aug 12, 2027	—	—	—		—
8071623	Mar 27, 2031	—	Yes	Yes	—	—
8143241	Aug 12, 2027	—	—	—		—
8436185	Apr 24, 2029	—	Yes	—	—	—
8859562	Aug 4, 2031	—	—	—		—
11091459	Mar 27, 2038	—	—	Yes	—	—
11673877	Mar 27, 2038	—	—	Yes		—
11730725	Jan 25, 2039	—	—	Yes	—	—

#002 — EQ 200MG BASE

RLD

8 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 26, 2023

#003 — EQ 300MG BASE

RLD

8 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 26, 2023