Azithromycin - Generic Drug Details
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
What are the generic drug sources for azithromycin and what is the scope of patent protection?
Azithromycin
is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hikma, Hospira, Mylan Asi, Rising, Sun Pharm Inds Ltd, Teva Parenteral, Thea Pharma, ACI, Alembic Pharms Ltd, Apotex Corp, Bionpharma Inc, Cspc Ouyi, Lupin Ltd, Mylan, Sunshine, Teva, Wockhardt, and Yung Shin Pharm, and is included in seventy NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Azithromycin has fifty-one patent family members in forty-three countries.
There are thirty-two drug master file entries for azithromycin. Fifty-eight suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for azithromycin
International Patents: | 51 |
US Patents: | 2 |
Tradenames: | 5 |
Applicants: | 33 |
NDAs: | 70 |
Drug Master File Entries: | 32 |
Finished Product Suppliers / Packagers: | 58 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 552 |
Patent Applications: | 5,799 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for azithromycin |
Drug Sales Revenues: | Drug sales revenues for azithromycin |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for azithromycin |
What excipients (inactive ingredients) are in azithromycin? | azithromycin excipients list |
DailyMed Link: | azithromycin at DailyMed |
Recent Clinical Trials for azithromycin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Rambam Health Care Campus | Phase 2 |
Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
Rajavithi Hospital | N/A |
Generic filers with tentative approvals for AZITHROMYCIN
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 1% | SOLUTION; OPHTHALMIC |
See Plans and Pricing | See Plans and Pricing | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL |
See Plans and Pricing | See Plans and Pricing | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for azithromycin
Drug Class | Macrolide Antimicrobial |
Medical Subject Heading (MeSH) Categories for azithromycin
Paragraph IV (Patent) Challenges for AZITHROMYCIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
AZASITE | Ophthalmic Solution | azithromycin | 1% | 050810 | 1 | 2011-03-03 |
US Patents and Regulatory Information for azithromycin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms | AZITHROMYCIN | azithromycin | FOR SUSPENSION;ORAL | 065419-001 | Jun 24, 2008 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Bionpharma Inc | AZITHROMYCIN | azithromycin | TABLET;ORAL | 210000-001 | Feb 26, 2019 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Pfizer | ZITHROMAX | azithromycin | FOR SUSPENSION;ORAL | 050710-002 | Oct 19, 1995 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 azithromycin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Thea Pharma | AZASITE | azithromycin | SOLUTION/DROPS;OPHTHALMIC | 050810-001 | Apr 27, 2007 | See Plans and Pricing | See Plans and Pricing |
Pfizer | ZITHROMAX | azithromycin | FOR SUSPENSION;ORAL | 050693-001 | Sep 28, 1994 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | ZMAX | azithromycin | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 050797-001 | Jun 10, 2005 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for azithromycin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1537859 | See Plans and Pricing | |
Poland | 1537859 | See Plans and Pricing | |
Germany | 602004016444 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading 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 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.