Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Mycapssa (2023)

Total Spending

$5.1M

Total Claims

567

Beneficiaries

Avg Cost/Unit

$112.56

Spending Trend

$364K(2020)→$4.1M(2021)→$4.5M(2022)→$5.1M(2023)

YoY Change:+4.9%

5yr CAGR:+6.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

2 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2024	SUPPL -6	View Letter (PDF)
Jun 30, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE

RLD

16 patents1 exclusivity▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Jun 26, 2020

Patents (16)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8329198	Sep 17, 2029	—	—	Yes	—	—
8535695	Sep 17, 2029	—	—	—		—
9265812	Sep 17, 2029	—	—	Yes	—	—
9566246	Sep 17, 2029	—	—	Yes	—	—
10238709	Feb 3, 2036	—	—	—		—
10695397	Feb 3, 2036	—	—	—		—
11052126	Feb 3, 2036	—	—	—		—
11141457	Dec 28, 2040	—	—	—		—
11338011	Feb 3, 2036	—	—	—		—
11510963	Feb 3, 2036	—	—	—		—
11857595	Feb 3, 2036	—	—	—		—
11890316	Dec 28, 2040	—	—	—		—
11969471	Sep 17, 2029	—	—	Yes	—	—
11986529	Sep 17, 2029	—	—	—		—
12246054	Feb 3, 2036	—	—	—		—
12251418	Feb 3, 2036	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-474	Jun 26, 2027	< 1 year