Azithromycin Patent Expiration
Azithromycin was first introduced by Pfizer Chemicals Div Pfizer Inc
Azithromycin Patents
Given below is the list of patents protecting Azithromycin, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Azasite | US6159458 | Sustained release ophthalmic compositions containing water soluble medicaments |
Nov 04, 2017
(Expired) | Thea Pharma |
| Azasite | US6239113 | Topical treatment or prevention of ocular infections |
Mar 31, 2019
(Expired) | Thea Pharma |
| Azasite | US6569443 | Topical treatment or prevention of ocular infections |
Mar 31, 2019
(Expired) | Thea Pharma |
| Azasite | US6861411 | Method of treating eye infections with azithromycin |
Nov 25, 2018
(Expired) | Thea Pharma |
| Azasite | US7056893 | Topical treatment for prevention of ocular infections |
Mar 31, 2019
(Expired) | Thea Pharma |
| Zithromax | US6268489 | Azithromycin dihydrate |
Jul 31, 2018
(Expired) | Pfizer |
| Zithromax | US6268489 | Azithromycin dihydrate |
Jul 31, 2018
(Expired) | Pfizer |
| Zithromax | US6268489 | Azithromycin dihydrate |
Jul 31, 2018
(Expired) | Pfizer |
| Zmax | US6068859 | Controlled-release dosage forms of Azithromycin |
May 30, 2017
(Expired) | Pf Prism Cv |
| Zmax | US6268489 | Azithromycin dihydrate |
Jul 31, 2018
(Expired) | Pf Prism Cv |
| Zmax | US6984403 | Azithromycin dosage forms with reduced side effects |
Feb 14, 2024
(Expired) | Pf Prism Cv |
| Zmax | US7887844 | Multiparticulate crystalline drug compositions having controlled release profiles |
Feb 14, 2024
(Expired) | Pf Prism Cv |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Azithromycin's patents.
Latest Legal Activities on Azithromycin's Patents
Given below is the list recent legal activities going on the following patents of Azithromycin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jul, 2022 | US7887844 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jul, 2018 | US7887844 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Feb, 2011 | US7887844 |
| Recordation of Patent Grant Mailed Critical | 15 Feb, 2011 | US7887844 |
| Email Notification Critical | 27 Jan, 2011 | US7887844 |
| Issue Notification Mailed Critical | 26 Jan, 2011 | US7887844 |
| Dispatch to FDC | 10 Jan, 2011 | US7887844 |
| Application Is Considered Ready for Issue Critical | 07 Jan, 2011 | US7887844 |
| Issue Fee Payment Verified Critical | 05 Jan, 2011 | US7887844 |
| Issue Fee Payment Received Critical | 05 Jan, 2011 | US7887844 |
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Azithromycin Generics
Several generic applications have been filed for Azithromycin. The first generic version for Azithromycin was by Sandoz Inc and was approved on Nov 14, 2005. And the latest generic version is by Hainan Poly Pharm Co Ltd and was approved on Jul 27, 2023.
Given below is the list of companies who have filed for Azithromycin generic.
1. ACI
Aci Healthcare Ltd has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Aci.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Jul 12, 2022 |
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Jul 15, 2022 |
2. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | Jan 27, 2020 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Jan 28, 2020 |
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Jan 28, 2020 |
3. AMNEAL
Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 19, 2018 |
| EQ 100MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 19, 2018 |
4. APOTEX CORP
Apotex Corp has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Apotex Corp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE | tablet | Discontinued | ORAL | N/A | Jul 13, 2011 |
| EQ 250MG BASE | tablet | Discontinued | ORAL | N/A | Jul 13, 2011 |
| EQ 600MG BASE | tablet | Discontinued | ORAL | N/A | Jul 13, 2011 |
5. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Jul 5, 2018 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Jul 5, 2018 |
| EQ 100MG BASE/5ML | for suspension | Prescription | ORAL | AB | Oct 9, 2018 |
| EQ 200MG BASE/5ML | for suspension | Prescription | ORAL | AB | Oct 9, 2018 |
6. AUROBINDO PHARMA USA
Aurobindo Pharma Usa Inc has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 600MG BASE | tablet | Discontinued | ORAL | N/A | Jan 8, 2007 |
7. BIONPHARMA
Bionpharma Inc has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Bionpharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | Dec 26, 2018 |
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Feb 26, 2019 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Feb 26, 2019 |
8. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 5 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Feb 11, 2008 |
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | Feb 11, 2008 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Feb 11, 2008 |
| EQ 100MG BASE/5ML | for suspension | Discontinued | ORAL | N/A | May 15, 2015 |
| EQ 200MG BASE/5ML | for suspension | Discontinued | ORAL | N/A | May 15, 2015 |
9. CSPC OUYI
Cspc Ouyi Pharmaceutical Co Ltd has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Cspc Ouyi.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | Sep 24, 2018 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Oct 25, 2018 |
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Apr 17, 2019 |
10. EPIC PHARMA LLC
Epic Pharma Llc has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/5ML | for suspension | Prescription | ORAL | AB | Apr 9, 2018 |
| EQ 100MG BASE/5ML | for suspension | Prescription | ORAL | AB | Apr 9, 2018 |
11. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jun 19, 2015 |
12. EXTROVIS
Extrovis Ag has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Extrovis.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE | tablet | Discontinued | ORAL | N/A | May 30, 2007 |
13. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Dec 13, 2005 |
14. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Nov 9, 2009 |
15. HAINAN POLY
Hainan Poly Pharm Co Ltd has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Hainan Poly.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 100MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 27, 2023 |
| EQ 200MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 27, 2023 |
16. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jan 18, 2007 |
17. HOSPIRA
Hospira Inc has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Hospira.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Jun 26, 2009 |
18. LUPIN LTD
Lupin Ltd has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Lupin Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | May 15, 2015 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | May 15, 2015 |
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | May 15, 2015 |
19. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE | tablet | Discontinued | ORAL | N/A | May 30, 2007 |
| EQ 500MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Mar 24, 2009 |
20. PLIVA
Pliva Inc has filed for 5 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Pliva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Nov 14, 2005 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Nov 14, 2005 |
| EQ 600MG BASE
(reference standard) | tablet | Prescription | ORAL | AB | Nov 14, 2005 |
| EQ 100MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 5, 2006 |
| EQ 200MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 5, 2006 |
21. RISING
Rising Pharma Holding Inc has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Jan 26, 2017 |
22. SANDOZ
Sandoz Inc has filed for 5 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Nov 14, 2005 |
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | Nov 14, 2005 |
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Nov 14, 2005 |
| EQ 100MG BASE/5ML | for suspension | Discontinued | ORAL | N/A | Sep 18, 2006 |
| EQ 200MG BASE/5ML | for suspension | Discontinued | ORAL | N/A | Sep 18, 2006 |
23. SLATE RUN PHARMA
Slate Run Pharmaceuticals Llc has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Slate Run Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Prescription | INJECTION | AP | Oct 9, 2018 |
24. SUN PHARM INDS LTD
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE/VIAL | injectable | Discontinued | INJECTION | N/A | Apr 2, 2013 |
25. SUNSHINE
Sunshine Lake Pharma Co Ltd has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Sunshine.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | Dec 6, 2018 |
| EQ 250MG BASE | tablet | Prescription | ORAL | AB | Dec 7, 2018 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Dec 7, 2018 |
26. TARO
Taro Pharmaceutical Industries Ltd has filed for 1 generic for Azithromycin. Given below are the details of the strengths of this generic introduced by Taro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 200MG BASE/5ML | for suspension | Discontinued | ORAL | N/A | Dec 11, 2019 |
27. TEVA
Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Teva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 600MG BASE | tablet | Discontinued | ORAL | N/A | Nov 14, 2005 |
| EQ 250MG BASE | tablet | Discontinued | ORAL | N/A | Nov 14, 2005 |
| EQ 500MG BASE | tablet | Prescription | ORAL | AB | Nov 14, 2005 |
28. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 100MG BASE/5ML | for suspension | Discontinued | ORAL | N/A | Jun 24, 2008 |
| EQ 200MG BASE/5ML | for suspension | Discontinued | ORAL | N/A | Jun 24, 2008 |
29. YUNG SHIN PHARM
Yung Shin Pharmaceutical Industrial Co Ltd has filed for 3 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Yung Shin Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 600MG BASE | tablet | Prescription | ORAL | AB | May 8, 2020 |
| EQ 500MG BASE | tablet | Discontinued | ORAL | N/A | Mar 17, 2021 |
| EQ 250MG BASE | tablet | Discontinued | ORAL | N/A | Jul 26, 2022 |
30. ZYDUS LIFESCIENCES
Zydus Lifesciences Global Fze has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 100MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 31, 2018 |
| EQ 200MG BASE/5ML | for suspension | Prescription | ORAL | AB | Jul 31, 2018 |
31. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Azithromycin. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 500MG BASE | tablet | Discontinued | ORAL | N/A | Apr 7, 2023 |
| EQ 250MG BASE | tablet | Discontinued | ORAL | N/A | Apr 11, 2023 |