Zomig Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Zomig.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 08 Nov, 2018 US7220767 (Litigated)
Request for Trial Denied 02 Feb, 2016 US7220767 (Litigated)
Request for Trial Denied 27 Jan, 2016 US6750237 (Litigated)
Recordation of Patent Grant Mailed 22 May, 2007 US7220767 (Litigated)
Patent Issue Date Used in PTA Calculation 22 May, 2007 US7220767 (Litigated)
Issue Notification Mailed 02 May, 2007 US7220767 (Litigated)
Dispatch to FDC 19 Apr, 2007 US7220767 (Litigated)
Issue Fee Payment Received 18 Apr, 2007 US7220767 (Litigated)
Application Is Considered Ready for Issue 18 Apr, 2007 US7220767 (Litigated)
Issue Fee Payment Verified 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.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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


Family Patents

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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.

Drug Owner Drug Name Treatment Area
Assertio
Cambia Used for relieving acute migraine attacks in adults, with or without aura.
Endo Operations
Frova Used for the acute treatment of migraine attacks in adults.

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
Zomig-zmt


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 Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Zomig.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 08 Nov, 2018 US7220767 (Litigated)
Request for Trial Denied 02 Feb, 2016 US7220767 (Litigated)
Request for Trial Denied 27 Jan, 2016 US6750237 (Litigated)
Recordation of Patent Grant Mailed 22 May, 2007 US7220767 (Litigated)
Patent Issue Date Used in PTA Calculation 22 May, 2007 US7220767 (Litigated)
Issue Notification Mailed 02 May, 2007 US7220767 (Litigated)
Dispatch to FDC 19 Apr, 2007 US7220767 (Litigated)
Issue Fee Payment Received 18 Apr, 2007 US7220767 (Litigated)
Application Is Considered Ready for Issue 18 Apr, 2007 US7220767 (Litigated)
Issue Fee Payment Verified 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


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.

Drug Owner Drug Name Treatment Area
Assertio
Cambia Used for relieving acute migraine attacks in adults, with or without aura.
Endo Operations
Frova Used for the acute treatment of migraine attacks in adults.

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
Zomig-zmt


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