Viewing data from:

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

2026

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

173 trials from ClinicalTrials.gov, 4 active, 118 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Study to Evaluate the Safety of Combining Two Radionuclide Therapies to Treat Mid-gut Neuroendocrine Tumors NCT03044977	Early Phase 1	Active	David Bushnell	20	2017-05-07 → 2027-12
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor NCT00569127	Phase 3	Active	National Cancer Institute (NCI)	427	2007-12-01 → 2027-01-31
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET NCT03972488	Phase 3	Active	Advanced Accelerator Applications	226	2020-01-08 → 2027-10-29
Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas NCT02333565	Phase 2	Completed	Assistance Publique Hopitaux De Marseille	20	2015-01-22 → 2023-05-24
RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding NCT03061604	N/A	Completed	Theodor Bilharz Research Institute	105	2014-11 → 2017-11
Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.NCT03455322	Phase 4	Completed	National Hepatology & Tropical Medicine Research Institute	60	2018-08-15 → 2020-07-10
Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly NCT00461149	Phase 4	Completed	Federico II University	50	1995-01 → 2006-12
Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea NCT00582426	Phase 3	Completed	Novartis Pharmaceuticals	139	2008-04 → 2010-09
Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide NCT00463983	Phase 1/2	Completed	Institut National de la Santé Et de la Recherche Médicale, France	25	2006-10 → 2012-01

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

API Supply Chain23 active DMFs4 inactive

22 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

SHILPA PHARMA LIFESCIENCES LTDOCTREOTIDE ACETATE USP

DMF 435232026

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

5 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Sep 27, 2024

Patents (5) · 12 use codes

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