Tygacil Patent Expiration

Tygacil is a drug owned by Pf Prism Cv. It is protected by 8 US drug patents filed from 2013 to 2020. Out of these, 6 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 08, 2030. Details of Tygacil'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).
US8372995 Crystalline solid forms of tigecycline and methods of preparing same
Oct, 2030

(5 years from now)

Active
US7879828 Tigecycline compositions and methods of preparation
Feb, 2029

(4 years from now)

Active
US8975242 Tigecycline compositions and methods of preparation
Oct, 2028

(3 years from now)

Active
US10588975 Tigecycline compositions and methods of preparation
Mar, 2026

(1 year, 3 months from now)

Active
US9254328 Tigecycline compositions and methods of preparation
Mar, 2026

(1 year, 3 months from now)

Active
US9694078 Tigecycline compositions and methods of preparation
Mar, 2026

(1 year, 3 months from now)

Active
USRE40183 7-Substituted-9-substituted amino-6-demethyl-6-deoxytetracyclines
Apr, 2016

(8 years ago)

Expired
USRE40086 Method for treating bacterial infection with novel 7-substituted-9-substituted amino 6-demethyl-6-deoxytetracyclines
Jun, 2013

(11 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 Tygacil's patents.

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

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)
Payment of Maintenance Fee, 4th Year, Large Entity 28 Sep, 2020 US9694078
Payment of Maintenance Fee, 8th Year, Large Entity 14 Jul, 2020 US8372995 (Litigated)
Recordation of Patent Grant Mailed 17 Mar, 2020 US10588975
Patent Issue Date Used in PTA Calculation 17 Mar, 2020 US10588975
Email Notification 27 Feb, 2020 US10588975


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 Tygacil and ongoing litigations to help you estimate the early arrival of Tygacil generic.

Tygacil's Litigations

Tygacil been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 08, 2014, against patent number US7879828. The petitioner Initiative for Responsibility in Drug Pricing LLC, challenged the validity of this patent, with Wyeth LLC as the respondent. Click below to track the latest information on how companies are challenging Tygacil's patents.

Last updated on December 3, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7879828 March, 2015 Terminated-Denied
(16 Sep, 2015)
Wyeth LLC Apotex Inc.
US7879828 November, 2013 FWD Entered
(20 Apr, 2015)
Wyeth LLC Apotex Inc.
US7879828 August, 2014 Terminated-Denied
(13 Feb, 2015)
Wyeth LLC Initiative for Responsibility in Drug Pricing LLC


FDA has granted some exclusivities to Tygacil. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tygacil, 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 Tygacil.

Exclusivity Information

Tygacil holds 3 exclusivities. All of its exclusivities have expired in 2012. Details of Tygacil's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-586) Mar 20, 2012
New Indication(I-587) Mar 20, 2012
New Indication(I-588) Mar 20, 2012

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Several oppositions have been filed on Tygacil's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tygacil's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tygacil patents.

Tygacil's Oppositions Filed in EPO

Tygacil has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 24, 2014, by Galenicum Health S.L.. This opposition was filed on patent number EP06760544A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP06737947A Jun, 2014 Hollatz, Christian Patent maintained as amended
EP06737947A Jun, 2014 Hollatz, Christian Patent maintained as amended
EP06737947A Jun, 2014 PENTAFARMA S.A. Patent maintained as amended
EP06737947A Jun, 2014 df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte ParG mbB Patent maintained as amended
EP06760544A Jan, 2014 Taylor Wessing LLP Revoked
EP06760544A Jan, 2014 Galenicum Health S.L. Revoked


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

Tygacil's Family Patents

Tygacil has patent protection in a total of 29 countries. It's US patent count contributes only to 16.7% of its total global patent coverage. 10 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Tygacil.

Family Patents

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Generic Launch

Generic Release Date:

Tygacil's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 08, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tygacil Generic API suppliers:

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

Alternative Brands for Tygacil

Tygacil which is used for treating bacterial infections., has several other brand drugs in the same treatment category and using the same active ingredient (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 Treatment Area
Abbvie
Teflaro Used for treating bacterial infections.
Baxter Hlthcare Corp
Zosyn In Plastic Container used for treating bacterial infections.
Cubist Pharms Llc
Cubicin Used for treating bacterial infections, including skin infections and bloodstream infections.
Sivextro Used for treating acute bacterial skin and skin structure infections caused by susceptible bacteria.
Cumberland
Vibativ Used for treating bacterial infections, including staphylococcal infections.
Lg Chem Ltd
Factive used for treating various bacterial infections.
Pfizer
Trovan Used for treating bacterial infections.
Trovan Preservative Free Used for treating bacterial infections.
Pf Prism Cv
Zmax used for treating bacterial infections.
Rempex
Minocin used for treating bacterial infections.
Shionogi Inc
Doribax Used for treating bacterial infections.
Wyeth Pharms
Zosyn Used for treating bacterial infections.
Xellia Pharms Aps
Vancomycin Used for treating bacterial infections.
Vancomycin Hydrochloride Used for treating bacterial infections.

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. Tigecycline. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Amneal
Tigecycline


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





About Tygacil

Tygacil is a drug owned by Pf Prism Cv. It is used for treating bacterial infections. Tygacil uses Tigecycline as an active ingredient. Tygacil was launched by Pf Prism Cv in 2005.

Approval Date:

Tygacil was approved by FDA for market use on 15 June, 2005.

Active Ingredient:

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

Treatment:

Tygacil is used for treating bacterial infections.

Dosage:

Tygacil 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