Viewing data from:

BIAXIN

NDA

CLARITHROMYCIN | N050698 | ABBVIE 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

234 trials from ClinicalTrials.gov — 2 recruiting, 6 active, 168 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gastric Cancer Prevention in the Family Members by Helicobacter Pylori Eradication NCT01678027	Phase 3	Active	National Cancer Center, Korea	1,838	2004-11 → 2035-12
Ixazomib with Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients with Multiple Myeloma NCT02542657	Phase 1/2	Active	Joseph Tuscano	30	2015-10 → 2025-12
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma NCT01559935	Phase 2	Active	Weill Medical College of Cornell University	74	2012-04-19 → 2027-03-01
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab NCT04302324	Phase 2	Active	Weill Medical College of Cornell University	11	2021-10-28 → 2027-12-28
Selinexor and Backbone Treatments of Multiple Myeloma Patients NCT02343042	Phase 1/2	Active	Karyopharm Therapeutics Inc	300	2015-10 → 2027-04
Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD NCT02407119	Phase 3	Active	National Cancer Center, Korea	470	2003-06 → 2030-06
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections NCT03236987	Phase 3	Recruiting	Centre Hospitalier Universitaire, Amiens	424	2018-02-05 → 2029-02-05
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment NCT04310930	Phase 2/3	Recruiting	The University of Queensland	300	2020-03-02 → 2030-06-30
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites NCT00000826	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	48	— → 1999-05
Intravenous Clarithromycin in Septic Syndrome NCT00297674	Phase 4	Completed	University of Athens	200	2004-06 → 2005-12

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

API Supply Chain8 active DMFs15 inactive

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

TAPI NL BVCLARITHROMYCIN USP

DMF 152762001

SYNTHIMED LABS PRIVATE LTDCLARITHROMYCIN

DMF 165182003

ALEMBIC PHARMACEUTICALS LTDCLARITHROMYCIN USP

DMF 200232006

ZHEJIANG BETTER PHARMACEUTICALS CO LTDCLARITHROMYCIN USP

DMF 205012007

HEC PHARM CO LTDCLARITHROMYCIN, NON-STERILE DRUG SUBSTANCE, BULK FORM

DMF 247092011

MURLI KRISHNA PHARMA PVT LTDCLARITHROMYCIN PELLETS 42.0 % W/W

DMF 274122013

CENTURY PHARMACEUTICALS LTDCLARITHROMYCIN USP

DMF 348002020

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDCLARITHROMYCIN 128 USP

DMF 359232021

XIAN PHARMACEUTICAL FACTORYInactiveCLARITHROMYCIN

DMF 147662000

FERMIC SA DE CVInactiveCLARITHROMYCIN

DMF 156152001

SANDOZ INDUSTRIAL PRODUCTS SAInactiveCLARITHROMYCIN (NON-STERILE BULK)

DMF 160832002

WOCKHARDT LTDInactiveCLARITHROMYCIN

DMF 162182002

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCLARITHROMYCIN USP

DMF 165632003

MYLAN LABORATORIES LTDInactiveCLARITHROMYCIN USP (CXP)

DMF 167082003

ALEMBIC LTDInactiveCLARITHROMYCIN

DMF 167462003

MYLAN LABORATORIES LTDInactiveCLARITHROMYCIN USP(COP)

DMF 173502004

WOCKHARDT BIO AGInactiveCLARITHROMYCIN USP

DMF 175242004

MYLAN LABORATORIES LTDInactiveCLARITHROMYCIN USP (CLP)

DMF 188662005

IND SWIFT LABORATORIES LTDInactiveCLARITHROMYCIN SPECIAL

DMF 192232006

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDInactiveCLARITHROMYCIN

DMF 193902006

ELDER PHARMACEUTICALS LTDInactiveCLARITHROMYCIN FORM II

DMF 219192008

IND SWIFT LABORATORIES LTDInactiveCLARITHROMYCIN CITRATE

DMF 226542009

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDInactiveCLARITHROMYCIN USP

DMF 259822012

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

Approval Letters

23 letters from Drugs@FDA

Date	Submission	Document
Sep 19, 2019	SUPPL -41	View Letter (PDF)
Dec 31, 2018	SUPPL -40	View Letter (PDF)
Dec 18, 2018	SUPPL -39	View Letter (PDF)
Jun 12, 2017	SUPPL -38	View Letter (PDF)
May 31, 2016	SUPPL -33	View Letter (PDF)
Oct 28, 2015	SUPPL -37	View Letter (PDF)
Jan 9, 2015	SUPPL -36	View Letter (PDF)
Jul 28, 2014	SUPPL -35	View Letter (PDF)
Sep 11, 2013	SUPPL -31	View Letter (PDF)
Sep 11, 2013	SUPPL -32	View Letter (PDF)
Jul 10, 2012	SUPPL -29	View Letter (PDF)
Jun 5, 2012	SUPPL -28	View Letter (PDF)
May 9, 2012	SUPPL -30	View Letter (PDF)
May 9, 2012	SUPPL -26	View Letter (PDF)
May 31, 2011	SUPPL -25	View Letter (PDF)
May 31, 2011	SUPPL -27	View Letter (PDF)
Nov 20, 2009	SUPPL -24	View Letter (PDF)
May 29, 2008	SUPPL -23	View Letter (PDF)
Jan 9, 2008	SUPPL -22	View Letter (PDF)
Jul 13, 2006	SUPPL -21	View Letter (PDF)
Oct 20, 2005	SUPPL -20	View Letter (PDF)
Jul 21, 2004	SUPPL -19	View Letter (PDF)
May 24, 2002	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 125MG/5ML

RLD

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Dec 23, 1993

No patent or exclusivity listings for this strength.

#002 — 250MG/5ML

RLD

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Dec 23, 1993

#003 — 187MG/5ML

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Sep 30, 1998