Zithromax is a drug owned by Pfizer Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 31, 2018. Details of Zithromax's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6268489 | Azithromycin dihydrate |
Jul, 2018
(8 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Zithromax and ongoing
litigations to
help you estimate the early arrival of Zithromax generic.
Zithromax's Litigations
Zithromax been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 01, 1, against patent number US6268489. The petitioner , challenged the validity of this patent, with ALLEN et al as the respondent. Click below to track the latest information on how companies are challenging Zithromax's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6268489 | January, 1 |
Decision
(15 Apr, 1998) | ALLEN et al | |
US patents provide insights into the exclusivity only within the United States, but
Zithromax is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Zithromax's family patents as well as insights into
ongoing legal events
on those patents.
Zithromax's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Zithromax:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Zithromax's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 31, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zithromax Generic API suppliers:
Azithromycin is the generic name for the brand Zithromax. 32 different companies have already filed for the generic of Zithromax, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zithromax's generic
Alternative Brands for Zithromax
There are several other brand drugs using the same active ingredient (Azithromycin) as Zithromax. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Azithromycin, Zithromax's active ingredient. Check the complete list of approved generic manufacturers for Zithromax
About Zithromax
Zithromax is a drug owned by Pfizer Inc. Zithromax uses Azithromycin as an active ingredient. Zithromax was launched by Pfizer in 2002.
Approval Date:
Zithromax was approved by FDA for market use on 24 May, 2002.
Active Ingredient:
Zithromax uses Azithromycin as the active ingredient. Check out other Drugs and Companies using Azithromycin ingredient
Dosage:
Zithromax is available in the following dosage forms - tablet form for oral use, for suspension form for oral use, injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 500MG BASE | TABLET | Prescription | ORAL |
| EQ 250MG BASE | TABLET | Prescription | ORAL |
| EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 100MG BASE/5ML | FOR SUSPENSION | Prescription | ORAL |
| EQ 200MG BASE/5ML | FOR SUSPENSION | Prescription | ORAL |
| EQ 1GM BASE/PACKET | FOR SUSPENSION | Discontinued | ORAL |
| EQ 500MG BASE/VIAL | INJECTABLE | Discontinued | INJECTION |