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LINCOCIN

NDA

LINCOMYCIN HYDROCHLORIDE | N050316 | PHARMACIA AND UPJOHN CO

2 strengths0 unique patents0 unique exclusivities

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

Medicare Part D Spending

CMS annual spending data for Lincocin (2023)

Total Spending

$950.19

Total Claims

Beneficiaries

Avg Cost/Unit

$13.20

Spending Trend

$6K(2019)→$3K(2020)→$2K(2021)→$1K(2022)→$950.19(2023)

YoY Change:-2.5%

5yr CAGR:-10.4%

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

Medicare Part B Spending

CMS physician-administered drug spending for Lincocin (2023)

Total Spending

$259K

Total Claims

17,723

Beneficiaries

12,242

ASP Price

—

HCPCS: J2010 — Injection, lincomycin hcl, up to 300 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain6 active DMFs6 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCLINCOMYCIN HYDROCHLORIDE USP

DMF 132921998

JIANGXI GUOYAO PHARMACEUTICAL LLCLINCOMYCIN HYDROCHLORIDE

DMF 137531998

NORTH CHINA PHARMACEUTICAL GROUP HUALUAN CO LTDLINCOMYCIN HYDROCHLORIDE

DMF 171422004

XINYU PHARMACEUTICAL CO LTDLINCOMYCIN HYDROCHLORIDE USP

DMF 190562005

NANYANG PUKANG PHARMACEUTICAL CO LTDLINCOMYCIN HYDROCHLORIDE

DMF 266102012

TOPFOND PHARMACEUTICAL CO LTDLINCOMYCIN HYDROCHLORIDE

DMF 371242022

CIBRANInactiveLINCOMYCIN HYDROCHLORIDE

DMF 137001998

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORYInactiveLINCOMYCIN HYDROCHLORIDE

DMF 137571998

ABBOTT INDUSTRIES INCInactiveLINCOMYCIN HYDROCHLORIDE MONOHYDRATE BULK

DMF 147521998

NINGXIA TAIYICIN BIOTECH CO LTDInactiveLINCOMYCIN HYDROCHLORIDE

DMF 314622017

LIVZON GROUP NINGXIA PHARMACEUTICAL CO LTDInactiveLINCOMYCIN HYDROCHLORIDE USP

DMF 323222017

NINGXIA TAIYICIN BIOTECH CO LTDInactiveLINCOMYCIN HYDROCHLORIDE

DMF 362502021

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 7, 2004	SUPPL -99	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 250MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982