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, 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: | 394 |
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 |
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 |
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
Anatomical Therapeutic Chemical (ATC) Classes for CLARITHROMYCIN
US Patents and Regulatory Information for CLARITHROMYCIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 065195-002 | Mar 11, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo | CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 065489-001 | Jul 25, 2012 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hec Pharm | CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 203584-002 | Sep 28, 2015 | AB | RX | 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 | ||||
Sandoz | CLARITHROMYCIN | clarithromycin | TABLET;ORAL | 065136-001 | Aug 25, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sunshine | CLARITHROMYCIN | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 208987-001 | Jul 9, 2018 | AB | RX | 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
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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