Viewing data from:

SINCALIDE

NDA

SINCALIDE | N210850 | MAIA PHARMACEUTICALS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

11110063

Apr. 20, 2038

11318100

Apr. 20, 2038

11737983

Apr. 20, 2038

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs1 inactive

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

BACHEM AGSINCALIDE

DMF 151652000

MATRIX PHARMACORP PRIVATE LTDSINCALIDE

DMF 323022018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSincalide

DMF 342022019

MSN LIFE SCIENCES PRIVATE LTDSINCALIDE

DMF 364292021

SUN PHARMACEUTICAL INDUSTRIES LTDSINCALIDE

DMF 408752025

BACHEM AMERICAS INCInactiveSINCALIDE

DMF 304312016

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 18, 2023	SUPPL -4	View Letter (PDF)
Nov 25, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005MG/VIAL

RLDAP

9 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Nov 22, 2022

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
11110063	Apr 20, 2038	—	—	Yes	—
11110063	Apr 20, 2038	—	—	Yes	—
11110063	Apr 20, 2038	—	—	Yes	—
11318100	Apr 20, 2038	—	—	Yes	—
11318100	Apr 20, 2038	—	—	Yes	—
11318100	Apr 20, 2038	—	—	Yes	—
11318100	Apr 20, 2038	—	—	Yes	—
11737983	Apr 20, 2038	—	—	Yes	—
11737983	Apr 20, 2038	—	—	Yes	—