ZITHROMAX Drug Patent Profile
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Which patents cover Zithromax, and what generic alternatives are available?
Zithromax is a drug marketed by Pfizer and is included in seven NDAs.
The generic ingredient in ZITHROMAX is azithromycin. There are thirty-two drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zithromax
A generic version of ZITHROMAX was approved as azithromycin by PLIVA on November 14th, 2005.
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Summary for ZITHROMAX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 105 |
| Patent Applications: | 3,137 |
| Drug Prices: | Drug price information for ZITHROMAX |
| Drug Sales Revenues: | Drug sales revenues for ZITHROMAX |
| What excipients (inactive ingredients) are in ZITHROMAX? | ZITHROMAX excipients list |
| DailyMed Link: | ZITHROMAX at DailyMed |
Recent Clinical Trials for ZITHROMAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit | Phase 2/Phase 3 |
| Mahidol Oxford Tropical Medicine Research Unit | Phase 2/Phase 3 |
| Brigham and Women's Hospital | Phase 1 |
Pharmacology for ZITHROMAX
| Drug Class | Macrolide Antimicrobial |
US Patents and Regulatory Information for ZITHROMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | ZITHROMAX | azithromycin | CAPSULE;ORAL | 050670-001 | Nov 1, 1991 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pfizer | ZITHROMAX | azithromycin | TABLET;ORAL | 050784-001 | May 24, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ZITHROMAX | azithromycin | FOR SUSPENSION;ORAL | 050710-002 | Oct 19, 1995 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ZITHROMAX | azithromycin | TABLET;ORAL | 050730-001 | Jun 12, 1996 | 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 ZITHROMAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | ZITHROMAX | azithromycin | FOR SUSPENSION;ORAL | 050693-001 | Sep 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZITHROMAX | azithromycin | INJECTABLE;INJECTION | 050733-001 | Jan 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZITHROMAX | azithromycin | TABLET;ORAL | 050711-001 | Jul 18, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ZITHROMAX | azithromycin | TABLET;ORAL | 050730-001 | Jun 12, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZITHROMAX
See the table below for patents covering ZITHROMAX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 1310642 | 2-AMINO-5-HYDROXY-4-PYRIMIDONES (2-AMINO-5-HYDROXY-4-PYRIMIDONES) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 8900423 | ⤷ Sign Up | |
| Ireland | 882107 | ⤷ Sign Up | |
| Ireland | 60354 | Azithromycin dihydrate | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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