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QMIIZ ODT

NDA

MELOXICAM | N211210 | TERSERA THERAPEUTICS LLC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

Today

8545879

Aug. 31, 2030

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pharmobedient Consulting, LLC FDA-2023-P-4279 · 4 docket documents Pharmobedient Consulting, LLC filed a citizen petition under Section 505(j) requesting that the FDA determine whether QMIIZ ODT (meloxicam) orally disintegrating tablets 7.5 mg and 15 mg, referenced under NDA 211210 held by Tersera, was withdrawn from commercial distribution for safety or effectiven	505(q)	2023-10-03	Granted	Pharmobedient Consulting, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

69 trials from ClinicalTrials.gov, 59 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Meloxicam 15 mg Tablets Under Fasting Conditions NCT00840476	Phase 1	Completed	Teva Pharmaceuticals USA	28	2004-02 → 2004-02
Aspirin Resistance in Systemic Lupus Erythematosus (SLE)NCT00731302	Phase 1	Completed	Vanderbilt University	70	2005-04 → 2017-04
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea NCT02255045	Phase 2/3	Completed	Laboratorios Andromaco S.A.	68	2014-06-27 → 2016-03-16
Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)NCT01789216	Phase 3	Completed	Major Extremity Trauma Research Consortium	450	2013-07 → 2018-12-31
Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects NCT02183077	Phase 1	Completed	Boehringer Ingelheim	12	1998-09
The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT NCT01638962	N/A	Completed	University of Southern Denmark	93	2012-08 → 2016-07
Meloxicam vs Placebo for Mobilization NCT02003625	Phase 2	Completed	Massachusetts General Hospital	31	2013-10 → 2019-04
Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects NCT02183090	Phase 1	Completed	Boehringer Ingelheim	12	1998-11
Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg Versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients With Osteoarthritis NCT02183064	Phase 3	Completed	Boehringer Ingelheim	1,309	1998-10
Bioequivalency Study of Meloxicam Tablets Under Fed Conditions NCT00601887	N/A	Completed	Roxane Laboratories	48	2005-03 → 2005-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain14 active DMFs9 inactive

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

BIDACHEM SPAMELOXICAM

DMF 138461998

ARCH PHARMALABS LTDMELOXICAM USP

DMF 159262002

UNICHEM LABORATORIES LTDMELOXICAM USP

DMF 161892002

CIPLA LTDMELOXICAM USP

DMF 171482004

ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPAMELOXICAM

DMF 172382004

ZYDUS LIFESCIENCES LTDMELOXICAM USP

DMF 173582004

UNIMARK REMEDIES LTDMELOXICAM USP

DMF 182862005

SWATI SPENTOSE PRIVATE LTDMELOXICAM

DMF 188372005

APITORIA PHARMA PRIVATE LTDMELOXICAM USP

DMF 189212005

QUIMICA SINTETICA SAMELOXICAM

DMF 189842005

DERIVADOS QUIMICOS SAUMELOXICAM

DMF 242052010

SHANDONG XINHUA PHARMACEUTICAL CO LTDMELOXICAM

DMF 244762010

IPCA LABORATORIES LTDMELOXICAM USP

DMF 375672022

APEX HEALTHCARE LTDMELOXICAM USP

DMF 399112024

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveMELOXICAM JETMILLED

DMF 144301999

ESTEVE QUIMICA SAInactiveMELOXICAM

DMF 166862003

DR REDDYS LABORATORIES LTDInactiveMELOXICAM

DMF 173662004

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMELOXICAM

DMF 182552005

ALKERMES INCInactiveMELOXICAM NANOCRYSTAL® TABLETS

DMF 188052005

CADILA PHARMACEUTICALS LTDInactiveMELOXICAM

DMF 192162006

SICHUAN SANCHINE SUNNYHOPE PHARMACEUTICAL CO LTDInactiveMELOXICAM USP (DRUG SUBSTANCE, NON-STERILE)

DMF 219482008

IROKO PHARMACEUTICALS LLCInactiveMELOXICAM SOLUMATRIX® CAPSULES

DMF 255082011

MICRO LABS LTD INDIAInactiveMELOXICAM USP

DMF 257852012

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 30, 2021	SUPPL -2	View Letter (PDF)
Aug 21, 2019	SUPPL -1	View Letter (PDF)
Oct 29, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 19, 2018

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8545879	Aug 31, 2030	—	—	Yes	—	—

#002 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

1 patent0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 19, 2018