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QUDEXY XR

NDA

TOPIRAMATE | N205122 | UPSHER SMITH LABORATORIES LLC

5 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

2033

Today

Mar. 19, 2033

Mar. 19, 2033

Mar. 19, 2033

Mar. 19, 2033

Mar. 19, 2033

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Upsher-Smith Laboratories, LLC v. Xiamen LP Pharmaceutical Co., Ltd. 1:2023cv00199 4 patentsANDA 215638topiramate	D. Del.	2023-02-23	Terminated 2024-07-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Qudexy XR (2023)

Total Spending

$1.4M

Total Claims

800

Beneficiaries

141

Avg Cost/Unit

$27.41

Spending Trend

$2.7M(2019)→$3.4M(2020)→$2.2M(2021)→$1.6M(2022)→$1.4M(2023)

YoY Change:+8.8%

5yr CAGR:+6.9%

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

API Supply Chain19 active DMFs11 inactive

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

JANSSEN PHARMACEUTICA NVTOPIRAMATE DRUG SUBSTANCE

DMF 109191994

CIPLA LTDTOPIRAMATE USP

DMF 156932001

DR REDDYS LABORATORIES LTDTOPIRAMATE USP

DMF 165332003

SCINOPHARM TAIWAN LTDTOPIRAMATE USP

DMF 170352003

ALIVUS LIFE SCIENCES LTDTOPIRAMATE USP

DMF 177292004

SUN PHARMACEUTICAL INDUSTRIES LTDTOPIRAMATE USP

DMF 181722005

HETERO DRUGS LTDTOPIRAMATE

DMF 183462005

ZYDUS LIFESCIENCES LTDTOPIRAMATE USP

DMF 187002005

APITORIA PHARMA PRIVATE LTDTOPIRAMATE USP

DMF 192472006

TORRENT PHARMACEUTICALS LTDTOPIRAMATE

DMF 203862007

ZAKLADY FARMACEUTYCZNE POLPHARMA SATOPIRAMATE

DMF 205812007

UNIMARK REMEDIES LTDTOPIRAMATE USP

DMF 209322007

UNIMARK REMEDIES LTDTOPIRAMATE USP (PROCESS A)

DMF 233492009

MSN ORGANICS PRIVATE LTDTOPIRAMATE USP [ROUTE CODE - "TI"]

DMF 257132012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTOPIRAMATE

DMF 283712014

UNICHEM LABORATORIES LTDTOPIRAMATE USP

DMF 351912020

GLOBAL CALCIUM PRIVATE LTDTOPIRAMATE USP

DMF 396362024

HUADONG MEDICINE (XI'AN) BODYGUARD PHARMACEUTICAL CO LTDTOPIRAMATE

DMF 408292024

SNJ LIFECARE PVT LTDTOPIRAMATE USP

DMF 420322025

CILAG AGInactiveTOPIRAMATE

DMF 109781994

FERRO PFANSTIEHL LABORATORIES INCInactiveTOPIRAMATE

DMF 156582001

ALKALOIDA CHEMICAL CO ZRTInactiveTOPIRAMATE

DMF 164052003

CF PHARMA LTDInactiveTOPIRAMATE

DMF 182692005

LUPIN LTDInactiveTOPIRAMATE USP

DMF 193252006

DIVIS LABORATORIES LTDInactiveTOPIRAMATE

DMF 210682007

SIGNA SA DE CVInactiveTOPIRAMATE USP

DMF 216572008

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveTOPIRAMATE

DMF 227452009

ALEMBIC PHARMACEUTICALS LTDInactiveTOPIRAMATE USP

DMF 248332011

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveTOPIRAMATE USP

DMF 269192013

ALEMBIC PHARMACEUTICALS LTDInactiveTOPIRAMATE

DMF 274392013

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Mar 9, 2026	SUPPL -19	View Letter (PDF)
Mar 14, 2025	SUPPL -17	View Letter (PDF)
Apr 1, 2024	SUPPL -16	View Letter (PDF)
Dec 5, 2022	SUPPL -14	View Letter (PDF)
Feb 8, 2022	SUPPL -12	View Letter (PDF)
Feb 22, 2021	SUPPL -11	View Letter (PDF)
Feb 18, 2020	SUPPL -10	View Letter (PDF)
Feb 22, 2019	SUPPL -8	View Letter (PDF)
Mar 30, 2017	SUPPL -5	View Letter (PDF)
Mar 30, 2017	SUPPL -3	View Letter (PDF)
Apr 20, 2016	SUPPL -3	View Letter (PDF)
Apr 2, 2015	SUPPL -1	View Letter (PDF)
Mar 13, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

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#001 — 25MG

RLDAB2

5 patents0 exclusivities▴