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DESVENLAFAXINE

NDA

DESVENLAFAXINE | N204150 | ALEMBIC PHARMACEUTICALS LTD

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 Desvenlafaxine ER (2023)

Total Spending

$2.0M

Total Claims

9,814

Beneficiaries

3,467

Avg Cost/Unit

$4.72

Spending Trend

$1.6M(2019)→$1.8M(2020)→$2.1M(2021)→$2.1M(2022)→$2.0M(2023)

YoY Change:+0.6%

5yr CAGR:+0.4%

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.

TAPI NL BVDESVENLAFAXINE BASE

DMF 263572012

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DESVENLAFAXINE USP

DMF 433542025

CADILA HEALTHCARE LTDInactiveDESVENLAFAXINE BASE

DMF 253482011

LUPIN MANUFACTURING SOLUTIONS LTDInactiveDESVENLAFAXINE BENZOATE

DMF 257272012

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2023	SUPPL -20	View Letter (PDF)
Sep 22, 2021	SUPPL -18	View Letter (PDF)
Oct 30, 2019	SUPPL -10	View Letter (PDF)
Dec 27, 2017	SUPPL -7	View Letter (PDF)
Jan 10, 2017	SUPPL -5	View Letter (PDF)
Sep 15, 2016	SUPPL -4	View Letter (PDF)
May 19, 2015	SUPPL -3	View Letter (PDF)
Jul 9, 2014	SUPPL -1	View Letter (PDF)
Jul 9, 2014	SUPPL -2	View Letter (PDF)
Mar 5, 2013	ORIG -1	View Letter (PDF)
Jan 11, 2013	ORIG -1	View Letter (PDF)
Jan 7, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 4, 2013

No patent or exclusivity listings for this strength.

#002 — 100MG

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 4, 2013