Zomig is a drug owned by Amneal Pharmaceuticals Llc. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 28, 2021. Details of Zomig'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). | |||
|
US7220767 (Pediatric) | Pharmaceutical formulations containing zolmitriptan |
May, 2021
(3 years ago) |
Expired
|
|
US6750237 (Pediatric) | Pharmaceutical formulations containing zolmitriptan |
May, 2021
(3 years ago) |
Expired
|
| US7220767 | Pharmaceutical formulations containing zolmitriptan |
Nov, 2020
(4 years ago) |
Expired
|
| US6750237 | Pharmaceutical formulations containing zolmitriptan |
Nov, 2020
(4 years ago) |
Expired
|
|
US5466699 (Pediatric) | Indolyl compounds for treating migraine |
May, 2013
(11 years ago) |
Expired
|
| US5466699 | Indolyl compounds for treating migraine |
Nov, 2012
(12 years ago) |
Expired
|
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 Zomig's patents.
Latest Legal Activities on Zomig's Patents
Given below is the list of recent legal activities going on the following patents of Zomig.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Nov, 2018 | US7220767 (Litigated) |
| Request for Trial Denied Critical | 02 Feb, 2016 | US7220767 (Litigated) |
| Request for Trial Denied Critical | 27 Jan, 2016 | US6750237 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 22 May, 2007 | US7220767 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 22 May, 2007 | US7220767 (Litigated) |
| Issue Notification Mailed Critical | 02 May, 2007 | US7220767 (Litigated) |
| Dispatch to FDC | 19 Apr, 2007 | US7220767 (Litigated) |
| Issue Fee Payment Received Critical | 18 Apr, 2007 | US7220767 (Litigated) |
| Application Is Considered Ready for Issue Critical | 18 Apr, 2007 | US7220767 (Litigated) |
| Issue Fee Payment Verified Critical | 18 Apr, 2007 | US7220767 (Litigated) |
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 Zomig and ongoing litigations to help you estimate the early arrival of Zomig generic.
Zomig's Litigations
Zomig been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 28, 2015, against patent number US6750237. The petitioner Lannett Holdings, Inc., challenged the validity of this patent, with AstraZeneca AB as the respondent. Click below to track the latest information on how companies are challenging Zomig's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7220767 | July, 2015 |
Terminated-Denied
(02 Feb, 2016) | AstraZeneca AB | Lannett Holdings, Inc. |
| US6750237 | July, 2015 |
Terminated-Denied
(27 Jan, 2016) | AstraZeneca AB | Lannett Holdings, Inc. |
FDA has granted some exclusivities to Zomig. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zomig, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zomig.
Exclusivity Information
Zomig holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Zomig's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jun 12, 2018 |
US patents provide insights into the exclusivity only within the United States, but Zomig 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 Zomig's family patents as well as insights into ongoing legal events on those patents.
Zomig's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zomig's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 28, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zomig Generic API suppliers:
Zolmitriptan is the generic name for the brand Zomig. 18 different companies have already filed for the generic of Zomig, with Macleods Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zomig's generic
How can I launch a generic of Zomig before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zomig's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zomig's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Zomig -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/spray | 09 Jun, 2016 | 1 | 28 Nov, 2020 | Extinguished | |
| 5 mg/spray | 14 Nov, 2013 | 1 | 28 Nov, 2020 | Extinguished |
Alternative Brands for Zomig
Zomig which is used for treating acute migraine attacks with or without aura in adults., has several other brand drugs in the same treatment category and using the same active ingredient (Zolmitriptan). 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 drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Zolmitriptan. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Astrazeneca |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Zolmitriptan, Zomig's active ingredient. Check the complete list of approved generic manufacturers for Zomig
About Zomig
Zomig is a drug owned by Amneal Pharmaceuticals Llc. It is used for treating acute migraine attacks with or without aura in adults. Zomig uses Zolmitriptan as an active ingredient. Zomig was launched by Amneal in 2013.
Approval Date:
Zomig was approved by FDA for market use on 16 September, 2013.
Active Ingredient:
Zomig uses Zolmitriptan as the active ingredient. Check out other Drugs and Companies using Zolmitriptan ingredient
Treatment:
Zomig is used for treating acute migraine attacks with or without aura in adults.
Dosage:
Zomig is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG/SPRAY | SPRAY | Prescription | NASAL |
| 5MG/SPRAY | SPRAY | Prescription | NASAL |
Zomig is a drug owned by Ipr Pharmaceuticals Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 12, 2018. Details of Zomig'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). | |||
|
US5863935 (Pediatric) | Therapeutic heterocyclic compounds |
May, 2013
(11 years ago) |
Expired
|
|
US5466699 (Pediatric) | Indolyl compounds for treating migraine |
May, 2013
(11 years ago) |
Expired
|
| US5466699 | Indolyl compounds for treating migraine |
Nov, 2012
(12 years ago) |
Expired
|
| US5863935 | Therapeutic heterocyclic compounds |
Nov, 2012
(12 years ago) |
Expired
|
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 Zomig's patents.
Latest Legal Activities on Zomig's Patents
Given below is the list of recent legal activities going on the following patents of Zomig.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Nov, 2018 | US7220767 (Litigated) |
| Request for Trial Denied Critical | 02 Feb, 2016 | US7220767 (Litigated) |
| Request for Trial Denied Critical | 27 Jan, 2016 | US6750237 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 22 May, 2007 | US7220767 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 22 May, 2007 | US7220767 (Litigated) |
| Issue Notification Mailed Critical | 02 May, 2007 | US7220767 (Litigated) |
| Dispatch to FDC | 19 Apr, 2007 | US7220767 (Litigated) |
| Issue Fee Payment Received Critical | 18 Apr, 2007 | US7220767 (Litigated) |
| Application Is Considered Ready for Issue Critical | 18 Apr, 2007 | US7220767 (Litigated) |
| Issue Fee Payment Verified Critical | 18 Apr, 2007 | US7220767 (Litigated) |
FDA has granted several exclusivities to Zomig. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zomig, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zomig.
Exclusivity Information
Zomig holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Zomig's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jun 12, 2018 |
US patents provide insights into the exclusivity only within the United States, but Zomig 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 Zomig's family patents as well as insights into ongoing legal events on those patents.
Zomig's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zomig's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 12, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zomig Generic API suppliers:
Zolmitriptan is the generic name for the brand Zomig. 18 different companies have already filed for the generic of Zomig, with Macleods Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zomig's generic
How can I launch a generic of Zomig before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zomig's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zomig's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Zomig -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/spray | 09 Jun, 2016 | 1 | 28 Nov, 2020 | Extinguished | |
| 5 mg/spray | 14 Nov, 2013 | 1 | 28 Nov, 2020 | Extinguished |
Alternative Brands for Zomig
Zomig which is used for treating acute migraine attacks with or without aura in adults., has several other brand drugs in the same treatment category and using the same active ingredient (Zolmitriptan). 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 drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Zolmitriptan. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Astrazeneca |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Zolmitriptan, Zomig's active ingredient. Check the complete list of approved generic manufacturers for Zomig
About Zomig
Zomig is a drug owned by Ipr Pharmaceuticals Inc. It is used for treating acute migraine attacks with or without aura in adults. Zomig uses Zolmitriptan as an active ingredient. Zomig was launched by Ipr in 1997.
Approval Date:
Zomig was approved by FDA for market use on 25 November, 1997.
Active Ingredient:
Zomig uses Zolmitriptan as the active ingredient. Check out other Drugs and Companies using Zolmitriptan ingredient
Treatment:
Zomig is used for treating acute migraine attacks with or without aura in adults.
Dosage:
Zomig is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG | TABLET | Discontinued | ORAL |
| 5MG | TABLET | Discontinued | ORAL |