Gloperba Patent Expiration

Gloperba is a drug owned by Scilex Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2019 to 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 20, 2037. Details of Gloperba'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).
US10226423 Colchicine drug-to-drug interactions
Dec, 2037

(12 years from now)

Active
US10383821 Colchicine drug-to-drug interactions
Nov, 2036

(11 years from now)

Active
US9907751 Composition and method of use of colchicine oral liquid
Nov, 2036

(11 years from now)

Active
US10383820 Colchicine drug-to-drug interactions
Nov, 2036

(11 years from now)

Active


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 Gloperba's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Yr, Small Entity 20 Feb, 2023 US10383820
Payment of Maintenance Fee, 4th Yr, Small Entity 20 Feb, 2023 US10383821
Payment of Maintenance Fee, 4th Yr, Small Entity 12 Sep, 2022 US10226423
Payment of Maintenance Fee, 4th Yr, Small Entity 07 Sep, 2021 US9907751
Patent Issue Date Used in PTA Calculation 20 Aug, 2019 US10383821
Recordation of Patent Grant Mailed 20 Aug, 2019 US10383821
Recordation of Patent Grant Mailed 20 Aug, 2019 US10383820
Patent Issue Date Used in PTA Calculation 20 Aug, 2019 US10383820
Email Notification 01 Aug, 2019 US10383820
Email Notification 01 Aug, 2019 US10383821

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US patents provide insights into the exclusivity only within the United States, but Gloperba 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 Gloperba's family patents as well as insights into ongoing legal events on those patents.

Gloperba's Family Patents

Gloperba has patent protection in a total of 2 countries. It has a significant patent presence in the US with 91.7% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Gloperba.

Family Patents

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Generic Launch

Generic Release Date:

Gloperba's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 20, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Gloperba Generic API suppliers:

Colchicine is the generic name for the brand Gloperba. 12 different companies have already filed for the generic of Gloperba, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gloperba's generic

How can I launch a generic of Gloperba before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Gloperba's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gloperba'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 Gloperba -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.6 mg/5 mL 02 Apr, 2020 1 20 Dec, 2037 Non-Forfeiture

Alternative Brands for Gloperba

Gloperba which is used for preventing gout flares in adults., has several other brand drugs using the same active ingredient (Colchicine). 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
Agepha Pharma Fz
Lodoco
Hikma Intl Pharms
Mitigare
Takeda Pharms Usa
Colcrys


Apart from brand drugs containing the same ingredient, some generics have also been filed for Colchicine, Gloperba's active ingredient. Check the complete list of approved generic manufacturers for Gloperba





About Gloperba

Gloperba is a drug owned by Scilex Pharmaceuticals Inc. It is used for preventing gout flares in adults. Gloperba uses Colchicine as an active ingredient. Gloperba was launched by Scilex Pharms in 2019.

Approval Date:

Gloperba was approved by FDA for market use on 30 January, 2019.

Active Ingredient:

Gloperba uses Colchicine as the active ingredient. Check out other Drugs and Companies using Colchicine ingredient

Treatment:

Gloperba is used for preventing gout flares in adults.

Dosage:

Gloperba is available in solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.6MG/5ML SOLUTION Prescription ORAL