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LODINE XL

NDA

ETODOLAC | N020584 | WYETH PHARMACEUTICALS INC

3 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - Orange book - Lodine Tablet-3 re: Suitability Petition from Ph... FDA-2023-P-4877 · 9 docket documents Pharmobedient Consulting filed a citizen petition regarding Lodine tablets, requesting a determination on the suitability of the drug product for inclusion in the Orange Book and its availability for generic drug development through abbreviated new drug application (ANDA) pathways.	Suitability	2023-11-03	Granted	Pharmobedient Consulting

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

Clinical Trials

18 trials from ClinicalTrials.gov — 1 recruiting, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Colorectal Metastasis Prevention International Trial 2 NCT03919461	Phase 2	Recruiting	Assaf-Harofeh Medical Center	200	2019-02-28 → 2027-02-28
Etodolac and Post-bleaching Sensitivity NCT02881619	Phase 4	Completed	Flavia Pardo Salata Nahsan	50	2014-11 → 2015-07
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fed Condition NCT01831687	Phase 1	Completed	IPCA Laboratories Ltd.	36	2012-12 → 2013-01
Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle Soreness NCT02695381	Phase 3	Completed	MEDRx USA, Inc.	100	2016-03 → 2016-09
Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition NCT01749228	Phase 1	Completed	IPCA Laboratories Ltd.	36	2012-10 → 2012-12
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition NCT01827865	Phase 1	Completed	IPCA Laboratories Ltd.	36	2012-11 → 2012-11
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
Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fasting Condition NCT01735370	Phase 1	Completed	IPCA Laboratories Ltd.	36	2012-05 → 2012-07
A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients NCT01118572	Phase 3	Completed	Astellas Pharma Inc	616	2010-02 → 2010-11
Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition NCT01746719	Phase 1	Completed	IPCA Laboratories Ltd.	36	2012-10 → 2012-12

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

API Supply Chain11 active DMFs11 inactive

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

AMSA SPAETODOLAC

DMF 113591995

ZAKLADY FARMACEUTYCZNE POLPHARMA SAETODOLAC

DMF 114051995

TAPI NL BVETODOLAC

DMF 117661995

TARO PHARMACEUTICAL INDUSTRIES LTDETODOLAC USP MICRONIZED

DMF 153392001

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTDETODOLAC

DMF 167892003

ZYDUS LIFESCIENCES LTDETODOLAC USP

DMF 236882010

KREATIVE ORGANICS PRIVATE LTDETODOLAC USP

DMF 244222010

IPCA LABORATORIES LTDETODOLAC USP (ED6 PROCESS)

DMF 248682011

ULKAR KIMYA SANAYII VE TICARET ASETODOLAC

DMF 249362011

EMCURE PHARMACEUTICALS LTDETODOLAC USP

DMF 258082012

IPCA LABORATORIES LTDETODOLAC USP (ED7 PROCESS)

DMF 275122013

LEDERLE LABORATORIES DIV AMERICAN CYANAMID COInactiveETODOLAC (ETODOLIC ACID)

DMF 53461984

UPJOHN COInactiveETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY

DMF 53831984

LONZA INCInactiveETODOLAC INTERMEDIATES

DMF 54371984

LONZA AGInactiveETODOLAC

DMF 57951985

QUIMICA SINTETICA SAInactiveETODOLAC

DMF 95291992

CHEMI SPAInactiveETODOLAC

DMF 117401995

RANBAXY PHARMACEUTICALS INCInactiveETODOLAC DRUG SUBSTANCE

DMF 126181997

CHEMSOURCE CORPInactiveETODOLAC DRUG SUBSTANCE

DMF 142981999

IPCA LABORATORIES LTDInactiveETODOLAC

DMF 214492008

YANGZHOU PHARMACEUTICAL CO LTDInactiveETODOLAC USP

DMF 215782008

FLEMING LABORATORIES LTDInactiveETODOLAC USP

DMF 319672017

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2006	SUPPL -9	View Letter (PDF)
May 26, 2005	SUPPL -4	View Letter (PDF)
May 26, 2005	SUPPL -6	View Letter (PDF)
May 26, 2005	SUPPL -7	View Letter (PDF)
Aug 11, 2000	SUPPL -5	View Letter (PDF)
May 27, 1999	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 25, 1996

No patent or exclusivity listings for this strength.

#002 — 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 25, 1996

#003 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 20, 1998