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BYNFEZIA PEN

NDA

OCTREOTIDE ACETATE | N213224 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

May. 15, 2038

Nov. 3, 2040

Nov. 3, 2040

Nov. 3, 2040

Dec. 29, 2041

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 Chain22 active DMFs4 inactive

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

POLYPEPTIDE LABORATORIES INCOCTREOTIDE ACETATE DRUG SUBSTANCE

DMF 149942000

SUN PHARMACEUTICAL INDUSTRIES LTDOCTREOTIDE ACETATE USP (PROCESS I)

DMF 176782004

TAPI NL BVOCTREOTIDE ACETATE

DMF 177772004

BCN PEPTIDES SAOCTREOTIDE ACETATE

DMF 187402005

CHEMI SPAOCTREOTIDE ACETATE

DMF 195672006

USV PRIVATE LTDOCTREOTIDE ACETATE USP

DMF 242882010

MATRIX PHARMACORP PRIVATE LTDOCTREOTIDE ACETATE USP

DMF 277292013

AMBIOPHARM INCOCTREOTIDE ACETATE

DMF 277592013

SUN PHARMACEUTICAL INDUSTRIES LTDOCTREOTIDE ACETATE USP (PROCESS-II)

DMF 279902014

AURO PEPTIDES LTDOCTREOTIDE ACETATE

DMF 294482015

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDOCTREOTIDE ACETATE

DMF 297102017

SCINOPHARM TAIWAN LTDOCTREOTIDE ACETATE

DMF 301312015

CHENGDU SHENGNUO BIOPHARM CO LTDOCTREOTIDE ACETATE USP

DMF 302492016

ALP PHARM BEIJING CO LTDOCTREOTIDE ACETATE

DMF 309922016

CHEMICAL AND BIOPHARMACEUTICAL LABORATORIES OF PATRAS SINGLE MEMBER SAOCTREOTIDE ACETATE

DMF 312772016

POLYPEPTIDE LABORATORIES SWEDEN ABOCTREOTIDE ACETATE

DMF 328632018

FRESENIUS KABI IPSUM SRLOCTREOTIDE ACETATE

DMF 341182020

BACHEM AGOCTREOTIDE ACETATE

DMF 341452019

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDOCTREOTIDE ACETATE

DMF 358162021

PIRAMAL PHARMA LTDOCTREOTIDE ACETATE

DMF 363222021

ALEMBIC PHARMACEUTICALS LTDOCTREOTIDE ACETATE USP

DMF 379132022

HARBIN JIXIANGLONG BIOTECH CO LTDOCTREOTIDE ACETATE

DMF 399372024

BACHEM AMERICAS INCInactiveOCTREOTIDE ACETATE USP

DMF 167602003

POLYPEPTIDE LABORATORIES INCInactiveOCTREOTIDE ACETATE BY GRANULATION

DMF 217042008

WOCKHARDT LTDInactiveOCTREOTIDE ACETATE

DMF 220682008

HEMMO PHARMACEUTICALS PVT LTDInactiveOCTREOTIDE ACETATE

DMF 263302012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 30, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)

RLD

13 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Sep 27, 2024

Patents (13)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10342850	May 15, 2038	—	—	Yes	—	—
11052196	Nov 3, 2040	—	—	—		—
11052196	Nov 3, 2040	—	—	—		—
11052196	Nov 3, 2040	—	—	—		—
11246991	Nov 3, 2040	—	—	—		—
11246991	Nov 3, 2040	—	—	—		—
11246991	Nov 3, 2040	—	—	—		—
11534553	Nov 3, 2040	—	—	—		—
11534553	Nov 3, 2040	—	—	—		—
11534553	Nov 3, 2040	—	—	—		—
12350475	Dec 29, 2041	—	—	—		—
12350475	Dec 29, 2041	—	—	—		—
12350475	Dec 29, 2041	—	—	—		—