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LOXITANE

NDA

LOXAPINE SUCCINATE | N017525 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

7 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 Loxapine (2023)

Total Spending

$4.1M

Total Claims

66,055

Beneficiaries

8,065

Avg Cost/Unit

$0.89

Spending Trend

$4.5M(2019)→$4.3M(2020)→$4.0M(2021)→$4.3M(2022)→$4.1M(2023)

YoY Change:-2.4%

5yr CAGR:+1.9%

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

API Supply Chain2 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MEDICHEM SALOXAPINE SUCCINATE

DMF 67671986

CENTAUR PHARMACEUTICALS PRIVATE LTDLOXAPINE SUCCINATE USP

DMF 299772015

MIKAH PHARMA LLCInactiveLOXAPINE SUCCINATE

DMF 75771988

PROFARMACO SRLInactiveLOXAPINE SUCCINATE

DMF 88121990

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -52	View Letter (PDF)
Feb 6, 2025	SUPPL -53	View Letter (PDF)
Mar 2, 2017	SUPPL -51	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#003 — EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#004 — EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#006 — EQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons**

RLD

0 patents0 exclusivities▾

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

#007 — EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#008 — EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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