Clarithromycin - Generic Drug Details

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What are the generic sources for clarithromycin and what is the scope of patent protection?

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, Mylan, 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-seven 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:	27
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	389
Patent Applications:	6,361
Formulation / Manufacturing:	see details
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
Fifth Affiliated Hospital, Sun Yat-Sen University	Phase 1
Minia University	N/A
Ain Shams University	N/A

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
Abbvie	BIAXIN	clarithromycin	FOR SUSPENSION;ORAL	050698-003	Sep 30, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065195-002	Mar 11, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	065195-001	Mar 11, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	CLARITHROMYCIN	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	065154-001	May 18, 2005	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	CLARITHROMYCIN	clarithromycin	TABLET;ORAL	206714-001	Apr 25, 2019		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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