BIAXIN XL Drug Patent Profile
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Which patents cover Biaxin Xl, and when can generic versions of Biaxin Xl launch?
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-six 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 24th, 2004.
Summary for BIAXIN XL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 48 |
Patent Applications: | 687 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIAXIN XL |
DailyMed Link: | BIAXIN XL at DailyMed |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for BIAXIN XL
US Patents and Regulatory Information for BIAXIN XL
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | BIAXIN XL | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 050775-001 | Mar 3, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | BIAXIN XL | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 050775-001 | Mar 3, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Bulgaria | 106683 | ⤷ Try a Trial | |
Israel | 131616 | EXTENDED RELEASE FORMULATIONS OF CLARITHROMYCIN | ⤷ Try a Trial |
Turkey | 200707263 | ⤷ Try a Trial | |
Israel | 149033 | ⤷ Try a Trial | |
South Korea | 100484559 | ⤷ Try a Trial | |
Germany | 69819481 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BIAXIN XL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0328535 | 96C0021 | Belgium | ⤷ Try a Trial | 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 |