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, 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| Abbvie | BIAXIN XL | clarithromycin | TABLET, EXTENDED RELEASE;ORAL | 050775-001 | Mar 3, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | BIAXIN | clarithromycin | FOR SUSPENSION;ORAL | 050698-003 | Sep 30, 1998 | 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
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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