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Generated: August 17, 2017
What are the generic drug sources for azithromycin and what is the scope of azithromycin patent protection?
Azithromycin is the generic ingredient in five branded drugs marketed by Hospira, Lupin Ltd, Gland Pharma Ltd, Wockhardt, Sagent Strides, Apotex Corp, Teva Parenteral, Sandoz, Pfizer, Oak Pharms Inc, Pliva, Teva Pharms, Sun Pharm Inds Ltd, Mylan Labs Ltd, Teva, Mylan, Pliva Hrvatska Doo, Fresenius Kabi Usa, Aurobindo Pharma Ltd, and Pf Prism Cv, and is included in forty-five NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 5 |
| Patents: | 9 |
| Applicants: | 20 |
| NDAs: | 45 |
| Drug Master File Entries: see list | 31 |
| Suppliers / Packagers: see list | 56 |
| Bulk Api Vendors: see list | 41 |
| Clinical Trials: see list | 298 |
| Patent Applications: see list | 5,296 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | azithromycin at DailyMed |
| Ingredient-type | Macrolides |
| Drug Class | Macrolide Antimicrobial |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 1% | SOLUTION; OPHTHALMIC |
| ► Subscribe | ► Subscribe | 500MG | INJECTABLE;INJECTION |
| ► Subscribe | ► Subscribe | 200MG/5ML | SUSPENSION;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Corp | AZITHROMYCIN | azithromycin | TABLET;ORAL | 065508-001 | Jul 13, 2011 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Oak Pharms Inc | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Wockhardt | AZITHROMYCIN | azithromycin | TABLET;ORAL | 065405-001 | Feb 11, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sandoz | AZITHROMYCIN | azithromycin | TABLET;ORAL | 065211-001 | Nov 14, 2005 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Aurobindo Pharma Ltd | AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 203294-001 | Jun 19, 2015 | AP | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | ZMAX | azithromycin | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 050797-001 | Jun 10, 2005 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Oak Pharms Inc | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,685,958 | Quinolone carboxylic acid compositions and related methods of treatment | ► Subscribe | |||||||||||||||||||||||||||
| 7,732,415 | Topical treatment or prevention of ocular infections | ► Subscribe | |||||||||||||||||||||||||||
| 7,108,865 | Controlled-release dosage forms of azithromycin | ► Subscribe | |||||||||||||||||||||||||||
| 6,699,492 | Quinolone carboxylic acid compositions and related methods of treatment | ► Subscribe | |||||||||||||||||||||||||||
| 7,749,970 | Topical treatment of prevention of ocular infections | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| African Regional IP Organization (ARIPO) | 44 | ► Subscribe | |||||||||||||||||||||||||||
| Guatemala | 200400183 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 8804925 | ► Subscribe | |||||||||||||||||||||||||||
| Finland | 883285 | ► Subscribe | |||||||||||||||||||||||||||
| Czechoslovakia | 8804896 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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