Tigecycline Patent Expiration

Tigecycline is a drug owned by Amneal Pharmaceuticals Llc. It is protected by 2 US drug patents filed in 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 07, 2033. Details of Tigecycline'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).
US9855355 Method and device for plasma-treating hollow bodies
Apr, 2033

(8 years from now)

Active
US9855335 Tigecycline composition for injection
Apr, 2033

(8 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 Tigecycline's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 11 Jul, 2024 US8372995 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 10 Aug, 2023 US10588975
Payment of Maintenance Fee, 8th Year, Large Entity 13 Jul, 2023 US9254328
Payment of Maintenance Fee, 8th Year, Large Entity 10 Aug, 2022 US8975242 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 13 Jul, 2022 US7879828 (Litigated)
Expire Patent 07 Feb, 2022 US9855355
Maintenance Fee Reminder Mailed 23 Aug, 2021 US9855355
Payment of Maintenance Fee, 4th Yr, Small Entity 07 Jul, 2021 US9855335
Surcharge for late Payment, Small Entity 07 Jul, 2021 US9855335
Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 11 Jun, 2021 US9855335

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

Tigecycline's Family Patents

Tigecycline has patent protection in a total of 8 countries. It's US patent count contributes only to 27.3% of its total global patent coverage. 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 Tigecycline.

Family Patents

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Generic Launch

Generic Release Date:

Tigecycline's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 07, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tigecycline Generic API suppliers:

Tigecycline is the generic name for the brand Tigecycline. 5 different companies have already filed for the generic of Tigecycline, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tigecycline's generic

Alternative Brands for Tigecycline

There are several other brand drugs using the same active ingredient (Tigecycline) as Tigecycline. 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
Pf Prism Cv
Tygacil


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





About Tigecycline

Tigecycline is a drug owned by Amneal Pharmaceuticals Llc. Tigecycline uses Tigecycline as an active ingredient. Tigecycline was launched by Amneal in 2018.

Can you believe Tigecycline received compensation for the extended wait time during the regulatory approval process?

A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

Approval Date:

Tigecycline was approved by FDA for market use on 02 August, 2018.

Active Ingredient:

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

Dosage:

Tigecycline is available in powder form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
50MG/VIAL POWDER Prescription INTRAVENOUS