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
(4 years from now) | Active |
| US7879828 | Tigecycline compositions and methods of preparation |
Feb, 2029
(3 years from now) | Active |
| US8975242 | Tigecycline compositions and methods of preparation |
Oct, 2028
(2 years from now) | Active |
| US9694078 | Tigecycline compositions and methods of preparation |
Mar, 2026
(3 months from now) | Active |
| US9254328 | Tigecycline compositions and methods of preparation |
Mar, 2026
(3 months from now) | Active |
| US10588975 | Tigecycline compositions and methods of preparation |
Mar, 2026
(3 months from now) | Active |
| USRE40183 | 7-Substituted-9-substituted amino-6-demethyl-6-deoxytetracyclines |
Apr, 2016
(9 years ago) |
Expired
|
| USRE40086 | Method for treating bacterial infection with novel 7-substituted-9-substituted amino 6-demethyl-6-deoxytetracyclines |
Jun, 2013
(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 Tygacil's patents.
Latest 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 |
|---|---|---|
| ||
| 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
Critical | 17 Mar, 2020 | US10588975 |
| Patent Issue Date Used in PTA Calculation
Critical | 17 Mar, 2020 | US10588975 |
| Email Notification
Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
| ||||
| US7879828 | March, 2015 |
Institution Denied
(16 Sep, 2015) | Wyeth LLC | Apotex Inc. et al. |
| US7879828 | March, 2015 |
Terminated-Denied
(16 Sep, 2015) | Wyeth LLC | Apotex Inc. |
| US7879828 | November, 2013 |
Final Written Decision
(20 Apr, 2015) | Wyeth LLC et al. | Apotex Inc. et al. |
| US7879828 | November, 2013 |
FWD Entered
(20 Apr, 2015) | Wyeth LLC | Apotex Inc. |
| US7879828 | August, 2014 |
Institution Denied
(13 Feb, 2015) | Wyeth LLC et al. | Initiative for Responsibility in Drug Pricing LLC |
| 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 |
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 |
|---|---|---|---|
| |||
| 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
Explore Our Curated Drug Screens
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 |
| |||||
| Baxter Hlthcare Corp |
| |||||
| Cubist Pharms Llc |
| |||||
| Cumberland |
| |||||
| Hikma |
| |||||
| Lg Chem Ltd |
| |||||
| Pfizer |
| |||||
| Pf Prism Cv |
| |||||
| Rempex |
| |||||
| Shionogi Inc |
| |||||
| Wyeth Pharms |
| |||||
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 |
|
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 |
