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PROTONIX

NDA

PANTOPRAZOLE SODIUM | N020987 | WYETH PHARMACEUTICALS LLC

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

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 Protonix (2023)

Total Spending

$15.4M

Total Claims

12,875

Beneficiaries

3,654

Avg Cost/Unit

$17.24

Spending Trend

$44.3M(2019)→$39.9M(2020)→$26.9M(2021)→$16.7M(2022)→$15.4M(2023)

YoY Change:+3.8%

5yr CAGR:+3.3%

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

API Supply Chain41 active DMFs19 inactive

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

PMC ISOCHEMPANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 158862002

SUN PHARMACEUTICAL INDUSTRIES LTDPANTOPRAZOLE SODIUM USP

DMF 170902004

DR REDDYS LABORATORIES LTDPANTOPRAZOLE SODIUM USP

DMF 171032004

TAPI NL BVPANTOPRAZOLE SODIUM

DMF 171182004

CIPLA LTDPANTOPRAZOLE SODIUM USP

DMF 177202004

QUIMICA SINTETICA SAPANTOPRAZOLE SODIUM

DMF 178482004

MATRIX PHARMACORP PRIVATE LTDPANTOPRAZOLE SODIUM USP (SESQUIHYDRATE)

DMF 182282005

HOLIDAY LABS MEXICO SA DE CVPANTOPRAZOLE SODIUM

DMF 184802005

MOEHS IBERICA SLPANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 187792005

APITORIA PHARMA PRIVATE LTDPANTOPRAZOLE SODIUM SESQUIHYDRATE USP

DMF 195782006

HETERO DRUGS LTDPANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 202712007

WOCKHARDT LTDPANTOPRAZOLE SODIUM USP

DMF 207632007

MSN LABORATORIES PRIVATE LTDPANTOPRAZOLE SODIUM USP [ROUTE CODE - 'PS']

DMF 208502007

JUBILANT PHARMOVA LTDPANTOPRAZOLE SODIUM USP

DMF 209892007

APOTEX PHARMACHEM INDIA PVT LTDPANTOPRAZOLE SODIUM SESQUIHYDRATE USP

DMF 219122008

ORBION PHARMACEUTICALS PRIVATE LTDPANTOPRAZOLE SODIUM (NON-STERILE BULK API)

DMF 220722008

MACLEODS PHARMACEUTICALS LTDPANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 222642008

RAKS PHARMA PVT LTDPANTOPRAZOLE SODIUM USP

DMF 246032011

DR REDDYS LABORATORIES LTDPANTOPRAZOLE SODIUM USP [PROCESS-2]

DMF 248132011

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDPANTOPRAZOLE SODIUM

DMF 254992011

EMCURE PHARMACEUTICALS LTDPANTOPRAZOLE SODIUM USP

DMF 269492013

ULKAR KIMYA SANAYII VE TICARET ASPANTOPRAZOLE SODIUM SESQUIHYDRATE USP

DMF 269972013

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDPANTOPRAZOLE SODIUM

DMF 273752013

SMS PHARMACEUTICALS LTDPANTOPRAZOLE SODIUM USP

DMF 291292015

VASUDHA PHARMA CHEM LTDPANTOPRAZOLE SODIUM USP

DMF 297392015

STERILE INDIA PVT LTDPANTOPRAZOLE SODIUM (STERILE)

DMF 299792016

JINZHOU JIUTAI PHARMACEUTICAL CO LTDPANTOPRAZOLE SODIUM

DMF 318082017

MSN LIFE SCIENCES PRIVATE LTDPANTOPRAZOLE SODIUM USP

DMF 340942019

MANKIND PHARMA LTDPANTOPRAZOLE SODIUM USP

DMF 353572020

METROCHEM API PRIVATE LTDPANTOPRAZOLE SODIUM

DMF 355772021

AZICO BIOPHORE INDIA PRIVATE LTDPANTOPRAZOLE SODIUM USP

DMF 355932021

SUN PHARMACEUTICAL INDUSTRIES LTDPANTOPRAZOLE SODIUM USP (PROCESS II)

DMF 357452021

IOL CHEMICALS AND PHARMACEUTICALS LTDPANTOPRAZOLE SODIUM USP

DMF 363752021

MANKIND PHARMA LTDPANTOPRAZOLE SODIUM USP (PROCESS II)

DMF 363932021

EVEREST ORGANICS LTDPANTOPRAZOLE SODIUM USP

DMF 367762022

GRANULES INDIA LTDPANTOPRAZOLE SODIUM SESQUIHYDRATE, USP

DMF 368492022

VASUDHA PHARMA CHEM LTDPANTOPRAZOLE SODIUM USP (PROCESS-II)

DMF 383282023

HUNAN WARRANT CHIRAL PHARMACEUTICAL CO LTDPANTOPRAZOLE SODIUM

DMF 387912023

APITORIA PHARMA PRIVATE LTDPANTOPRAZOLE SODIUM USP (PROCESS-II)

DMF 395972024

LEE PHARMA LTDPANTOPRAZOLE SODIUM

DMF 412762025

GRAVITI PHARMACEUTICALS PRIVATE LTDPANTOPRAZOLE SODIUM USP

DMF 430812025

TAKEDA GMBHInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 82431989

ESTEVE QUIMICA SAInactivePANTOPRAZOLE SODIUM

DMF 166572003

DOTTIKON EXCLUSIVE SYNTHESIS AGInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 167672003

MEDICHEM SAInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 182832005

LUPIN LTDInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 192272006

TEVA PHARMACEUTICAL INDUSTRIES LTDInactivePANTOPRAZOLE SODIUM

DMF 199172006

AMINO CHEMICALS LTDInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 202052007

ERREGIERRE SPAInactivePANTOPRAZOLE SODIUM

DMF 203422007

WANBURY LTDInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 205832007

ESTEVE QUIMICA SAInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 206962007

DR REDDYS LABORATORIES LTDInactivePantoprazole Sodium Sesquihydrate

DMF 211762007

SUN PHARMACEUTICAL INDUSTRIES LTDInactivePANTOPRAZOLE SODIUM USP

DMF 212042007

NATCO PHARMA LTDInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 215952008

SMS PHARMACEUTICALS LTDInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE

DMF 221612008

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactivePANTOPRAZOLE SODIUM

DMF 243132010

HETERO DRUGS LTDInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE, USP (PROCESS II)

DMF 244062010

IPCA LABORATORIES LTDInactivePANTOPRAZOLE SODIUM USP

DMF 246132011

GRANULES INDIA LTDInactivePANTOPRAZOLE SODIUM SESQUIHYDRATE USP

DMF 251662011

SMILAX LABORATORIES LTDInactivePANTOPRAZOLE SODIUM

DMF 255832011

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

Approval Letters

30 letters from Drugs@FDA

Date	Submission	Document
Jul 19, 2023	SUPPL -60	View Letter (PDF)
Mar 7, 2022	SUPPL -58	View Letter (PDF)
Nov 30, 2020	SUPPL -56	View Letter (PDF)
Oct 4, 2019	SUPPL -52	View Letter (PDF)
Apr 26, 2019	SUPPL -55	View Letter (PDF)
Jun 14, 2018	SUPPL -54	View Letter (PDF)
Dec 27, 2017	SUPPL -51	View Letter (PDF)
Jul 10, 2017	SUPPL -53	View Letter (PDF)
Oct 26, 2016	SUPPL -50	View Letter (PDF)
Dec 24, 2014	SUPPL -49	View Letter (PDF)
Dec 13, 2013	SUPPL -48	View Letter (PDF)
Oct 11, 2012	SUPPL -43	View Letter (PDF)
Oct 31, 2011	SUPPL -39	View Letter (PDF)
May 25, 2011	SUPPL -41	View Letter (PDF)
Sep 8, 2010	SUPPL -38	View Letter (PDF)
Nov 25, 2009	SUPPL -36	View Letter (PDF)
Nov 25, 2009	SUPPL -37	View Letter (PDF)
Jan 9, 2008	SUPPL -35	View Letter (PDF)
Jul 27, 2006	SUPPL -32	View Letter (PDF)
Dec 2, 2004	SUPPL -26	View Letter (PDF)
May 7, 2004	SUPPL -20	View Letter (PDF)
Mar 16, 2004	SUPPL -23	View Letter (PDF)
Mar 10, 2004	SUPPL -17	View Letter (PDF)
Jan 14, 2004	SUPPL -22	View Letter (PDF)
Jan 14, 2004	SUPPL -21	View Letter (PDF)
Oct 28, 2002	SUPPL -13	View Letter (PDF)
Apr 19, 2002	SUPPL -7	View Letter (PDF)
Jun 12, 2001	SUPPL -2	View Letter (PDF)
Jun 12, 2001	SUPPL -1	View Letter (PDF)
Feb 2, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 40MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Feb 2, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Jun 12, 2001