Letairis is a drug owned by Gilead Sciences Inc. It is protected by 9 US drug patents filed from 2013 to 2017. Out of these, 3 drug patents are active and 6 have expired. Letairis's patents have been open to challenges since 16 June, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 14, 2031. Details of Letairis'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). | |||
| US9549926 | Compositions and methods of treating pulmonary hypertension |
Oct, 2031
(5 years from now) | Active |
| US8377933 | Method for treating a pulmonary hypertension condition |
Dec, 2027
(2 years from now) | Active |
| US9474752 | Method for treating a pulmonary hypertension condition |
Dec, 2027
(2 years from now) | Active |
| USRE42462 | Carboxylic acid derivatives, their preparation and use |
Jul, 2018
(7 years ago) |
Expired
|
| US5840722 | Use of carboxylic acid derivatives as drugs |
Nov, 2015
(9 years ago) |
Expired
|
| US8349843 | Carboxylic acid derivatives, their preparation and use |
Oct, 2015
(10 years ago) |
Expired
|
| US7601730 | Carboxylic acid derivatives, their preparation and use |
Oct, 2015
(10 years ago) |
Expired
|
| US7109205 | Carboxylic acid derivatives, their preparation and use |
Oct, 2015
(10 years ago) |
Expired
|
| US5703017 | 3-(Het) arylcarboxylic acid derivatives, their preparation and intermediates for their preparation |
Dec, 2014
(10 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 Letairis's patents.
Latest Legal Activities on Letairis's Patents
Given below is the list of recent legal activities going on the following patents of Letairis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jul, 2024 | US9549926 |
| Expire Patent
Critical | 15 Feb, 2021 | US8349843 |
| Maintenance Fee Reminder Mailed
Critical | 31 Aug, 2020 | US8349843 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Aug, 2020 | US8377933 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Jul, 2020 | US9549926 |
| Expire Patent
Critical | 22 Oct, 2018 | US7109205 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 30 Apr, 2018 | US7109205 (Litigated) |
| Expire Patent
Critical | 13 Nov, 2017 | US7601730 |
| Patent Issue Date Used in PTA Calculation
Critical | 24 Jan, 2017 | US9549926 |
| Recordation of Patent Grant Mailed
Critical | 24 Jan, 2017 | US9549926 |
FDA has granted several exclusivities to Letairis. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Letairis, 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
Letairis.
Exclusivity Information
Letairis holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Letairis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 15, 2012 |
| Orphan Drug Exclusivity(ODE) | Jun 15, 2014 |
| New Indication(I-716) | Oct 02, 2018 |
Several oppositions have been filed on Letairis'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 Letairis's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Letairis patents.
Letairis's Oppositions Filed in EPO
Letairis has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 18, 2016, by Teva Pharmaceutical Industries, Ltd.. This opposition was filed on patent number EP07855065A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11833507A | Dec, 2017 | SANDOZ AG | Revoked |
| EP11833507A | Dec, 2017 | Zentiva Group, a.s. | Revoked |
| EP11833507A | Dec, 2017 | Generics (U.K.) Limited | Revoked |
| EP11833507A | Dec, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP11833507A | Dec, 2017 | STADA Arzneimittel AG | Revoked |
| EP11833507A | Dec, 2017 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
| EP07855065A | Feb, 2016 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
| EP07855065A | Feb, 2016 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Letairis 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 Letairis's family patents as well as insights into
ongoing legal events
on those patents.
Letairis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Letairis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 14, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Letairis Generic API suppliers:
Ambrisentan is the generic name for the brand Letairis. 9 different companies have already filed for the generic of Letairis, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Letairis's generic
How can I launch a generic of Letairis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Letairis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Letairis'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 Letairis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 09 Feb, 2015 | 1 | 28 Mar, 2019 | 09 Jul, 2018 | Extinguished |
About Letairis
Letairis is a drug owned by Gilead Sciences Inc. It is used for treating pulmonary arterial hypertension (PAH) in combination with tadalafil by inhibiting endothelin receptors. Letairis uses Ambrisentan as an active ingredient. Letairis was launched by Gilead in 2007.
Approval Date:
Letairis was approved by FDA for market use on 15 June, 2007.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Letairis is 15 June, 2007, its NCE-1 date is estimated to be 16 June, 2011.
Active Ingredient:
Letairis uses Ambrisentan as the active ingredient. Check out other Drugs and Companies using Ambrisentan ingredient
Treatment:
Letairis is used for treating pulmonary arterial hypertension (PAH) in combination with tadalafil by inhibiting endothelin receptors.
Dosage:
Letairis is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |