BIAXIN XL Drug Patent Profile

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When do Biaxin Xl patents expire, and what generic alternatives are available?

Biaxin Xl is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in BIAXIN XL is clarithromycin. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Biaxin Xl

A generic version of BIAXIN XL was approved as clarithromycin by ACTAVIS LABS FL INC on June 24^th, 2004.

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Summary for BIAXIN XL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	48
Patent Applications:	2,317
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIAXIN XL
DailyMed Link:	BIAXIN XL at DailyMed

Drug patent expirations by year for BIAXIN XL

Recent Clinical Trials for BIAXIN XL

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

Sponsor	Phase
Emory University	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
Nicolaas Bohnen, MD, PhD	Phase 1/Phase 2

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US Patents and Regulatory Information for BIAXIN XL

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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 XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000		DISCN	Yes	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 BIAXIN XL

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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

International Patents for BIAXIN XL

See the table below for patents covering BIAXIN XL around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	0010485		⤷ Sign Up
Japan	2001524955		⤷ Sign Up
Israel	223035		⤷ Sign Up
New Zealand	537410	Extended release formulations of clarithromycin that minimise adverse effects and provide at least equivalent to tablet or liquid formulations	⤷ Sign Up
Bulgaria	65188		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BIAXIN XL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium	⤷ Sign Up	PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for BIAXIN XL

Recent Clinical Trials for BIAXIN XL

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