CLARITHROMYCIN - Generic Drug Details

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What are the generic sources for clarithromycin and what is the scope of freedom to operate?

Clarithromycin is the generic ingredient in three branded drugs marketed by Abbvie, Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Lupin Ltd, Nostrum Labs Inc, Ranbaxy, Sunshine, Ajanta Pharma Ltd, Alembic, Aurobindo, Chartwell, Hec Pharm, Hikma, Ivax Sub Teva Pharms, Norvium Bioscience, Strides Pharma, Teva, and Wockhardt, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for clarithromycin. Twenty-eight suppliers are listed for this compound.

Summary for CLARITHROMYCIN

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	26
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	394
Patent Applications:	6,361
Drug Prices:	Drug price trends for CLARITHROMYCIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLARITHROMYCIN
What excipients (inactive ingredients) are in CLARITHROMYCIN?	CLARITHROMYCIN excipients list
DailyMed Link:	CLARITHROMYCIN at DailyMed

See drug prices for CLARITHROMYCIN

Drug Sales Revenue Trends for CLARITHROMYCIN

See drug sales revenues for CLARITHROMYCIN

Recent Clinical Trials for CLARITHROMYCIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alexandria University	Phase 3
Fu Jen Catholic University Hospital	Phase 4
Fifth Affiliated Hospital, Sun Yat-Sen University	Phase 1

See all CLARITHROMYCIN clinical trials

Pharmacology for CLARITHROMYCIN

Drug Class	Macrolide Antimicrobial
Mechanism of Action	Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for CLARITHROMYCIN

Anti-Bacterial Agents
Cytochrome P-450 CYP3A Inhibitors
Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CLARITHROMYCIN

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CLARITHROMYCIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	CLARITHROMYCIN	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	065250-001	Aug 25, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065266-002	May 31, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065266-001	May 31, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	CLARITHROMYCIN	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	065145-001	Jun 24, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	CLARITHROMYCIN	clarithromycin	FOR SUSPENSION;ORAL	065382-001	Aug 30, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CLARITHROMYCIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	⤷ Sign Up	⤷ Sign Up
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	⤷ Sign Up	⤷ Sign Up
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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