Esbriet is a drug owned by Genentech Inc. It is protected by 22 US drug patents filed from 2014 to 2019. Out of these, 21 drug patents are active and 1 has expired. Esbriet's patents have been open to challenges since 15 October, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 28, 2037. Details of Esbriet'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). | |||
| US10188637 | Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same |
Mar, 2037
(12 years from now) | Active |
| US8778947 | Methods of administering pirfenidone therapy |
Aug, 2033
(8 years from now) | Active |
| US8648098 | Pirfenidone therapy and inducers of cytochrome P450 |
Jan, 2030
(5 years from now) | Active |
| US8013002 | Methods of administering pirfenidone therapy |
Jan, 2030
(5 years from now) | Active |
| US8318780 | Methods of administering pirfenidone therapy |
Jan, 2030
(5 years from now) | Active |
| US7910610 | Methods of administering pirfenidone therapy |
Jan, 2030
(5 years from now) | Active |
| US8084475 | Pirfenidone therapy and inducers of cytochrome P450 |
Jan, 2030
(5 years from now) | Active |
| US7816383 | Methods of administering pirfenidone therapy |
Jan, 2030
(5 years from now) | Active |
| US8754109 | Pirfenidone therapy and inducers of cytochrome P450 |
Jan, 2030
(5 years from now) | Active |
| US7566729 | Modifying pirfenidone treatment for patients with atypical liver function |
Apr, 2029
(4 years from now) | Active |
| US8592462 | Pirfenidone treatment for patients with atypical liver function |
Apr, 2029
(4 years from now) | Active |
| US8609701 | Pirfenidone treatment for patients with atypical liver function |
Apr, 2029
(4 years from now) | Active |
| US7635707 | Pirfenidone treatment for patients with atypical liver function |
Apr, 2029
(4 years from now) | Active |
| US8383150 | Granulate formulation of pirfenidone and pharmaceutically acceptable excipients |
May, 2028
(3 years from now) | Active |
| US7767700 | Method of providing pirfenidone therapy to a patient |
Dec, 2027
(3 years from now) | Active |
| US8420674 | Method of providing pirfenidone therapy to a patient |
Dec, 2027
(3 years from now) | Active |
| US7696236 | Method of providing pirfenidone therapy to a patient |
Dec, 2027
(3 years from now) | Active |
| US7696326 | Multiple antigen glycopeptide carbohydrate, vaccine comprising the same and use thereof |
Dec, 2027
(3 years from now) | Active |
| US8753679 | Capsule formulation of pirfenidone and pharmaceutically acceptable excipients |
Sep, 2026
(1 year, 9 months from now) | Active |
| US7767225 | Capsule formulation of pirfenidone and pharmaceutically acceptable excipients |
Sep, 2026
(1 year, 9 months from now) | Active |
| US7988994 | Capsule formulation of pirfenidone and pharmaceutically acceptable excipients |
Sep, 2026
(1 year, 9 months from now) | Active |
| US9561217 | Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone |
Jan, 2022
(2 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 Esbriet's patents.
Latest Legal Activities on Esbriet's Patents
Given below is the list of recent legal activities going on the following patents of Esbriet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 May, 2024 | US8318780 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Jun, 2023 | US8084475 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Feb, 2023 | US8013002 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Jan, 2023 | US7988994 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Sep, 2022 | US7910610 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Jul, 2022 | US10188637 |
| Expire Patent Critical | 16 May, 2022 | US7696326 |
| Withdrawal of Application for PTE Critical | 20 Apr, 2022 | US7767225 |
| Withdrawal of Application for PTE Critical | 20 Apr, 2022 | US7988994 |
| Withdrawal of Application for PTE Critical | 20 Apr, 2022 | US7767700 |
FDA has granted several exclusivities to Esbriet. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Esbriet, 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 Esbriet.
Exclusivity Information
Esbriet holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Esbriet's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 15, 2019 |
| Orphan Drug Exclusivity(ODE) | Oct 15, 2021 |
| Orphan Drug Exclusivity(ODE-77) | Oct 15, 2021 |
Several oppositions have been filed on Esbriet'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 Esbriet's generic, the next section provides detailed information on ongoing and past EP oppositions related to Esbriet patents.
Esbriet's Oppositions Filed in EPO
Esbriet has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 28, 2012, by Sandoz Ag. This opposition was filed on patent number EP10250379A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16151564A | Mar, 2022 | Zentiva k.s. | Granted and Under Opposition |
| EP16151564A | Mar, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP16151564A | Mar, 2022 | Generics [UK] Limited | Granted and Under Opposition |
| EP16151564A | Mar, 2022 | Aera A/S | Granted and Under Opposition |
| EP17716354A | Feb, 2022 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP13176914A | Feb, 2021 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP13176914A | Feb, 2021 | Intas Pharmaceuticals Ltd. | Granted and Under Opposition |
| EP13176914A | Feb, 2021 | Aera A/S | Granted and Under Opposition |
| EP10835207A | Feb, 2021 | Intas Pharmaceuticals Ltd. | Revoked |
| EP10835207A | Feb, 2021 | Generics [UK] Limited | Revoked |
| EP10835207A | Feb, 2021 | SANDOZ AG | Revoked |
| EP13176914A | Feb, 2021 | SANDOZ AG | Granted and Under Opposition |
| EP10835207A | Feb, 2021 | Aera A/S | Revoked |
| EP10835207A | Jan, 2021 | STADA Arzneimittel AG | Revoked |
| EP10835207A | Jan, 2021 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
| EP13275196A | Jun, 2017 | Sandoz AG | Revoked |
| EP13275196A | Jun, 2017 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
| EP11002040A | Jan, 2017 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
| EP11002040A | Jan, 2017 | Sandoz AG | Revoked |
| EP12166074A | Jan, 2017 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
| EP12166074A | Dec, 2016 | Sandoz AG | Revoked |
| EP12166074A | Dec, 2016 | ratiopharm GmbH | Revoked |
| EP11002040A | Dec, 2016 | ratiopharm GmbH | Revoked |
| EP11001414A | Jul, 2015 | Sandoz AG | Revoked |
| EP06815221A | Mar, 2015 | Dannenberger, Oliver Andre | Patent maintained as amended |
| EP10250379A | Jun, 2012 | Sandoz AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Esbriet 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 Esbriet's family patents as well as insights into ongoing legal events on those patents.
Esbriet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Esbriet's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 28, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Esbriet Generic API suppliers:
Pirfenidone is the generic name for the brand Esbriet. 13 different companies have already filed for the generic of Esbriet, with Laurus having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Esbriet's generic
How can I launch a generic of Esbriet before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Esbriet's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Esbriet'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 Esbriet -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 267 mg | 15 Oct, 2018 | 9 | 03 Jan, 2022 | 30 Aug, 2033 | Eligible |
| 267 mg and 801 mg | 15 Oct, 2018 | 17 | 25 Jan, 2022 | 30 Aug, 2033 | Eligible |
| 534 mg | 15 Oct, 2018 | 2 | 19 Jul, 2022 | 30 Aug, 2033 | Eligible |
About Esbriet
Esbriet is a drug owned by Genentech Inc. It is used for treating idiopathic pulmonary fibrosis. Esbriet uses Pirfenidone as an active ingredient. Esbriet was launched by Genentech Inc in 2017.
Approval Date:
Esbriet was approved by FDA for market use on 11 January, 2017.
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 Esbriet is 11 January, 2017, its NCE-1 date is estimated to be 15 October, 2018.
Active Ingredient:
Esbriet uses Pirfenidone as the active ingredient. Check out other Drugs and Companies using Pirfenidone ingredient
Treatment:
Esbriet is used for treating idiopathic pulmonary fibrosis.
Dosage:
Esbriet is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 801MG | TABLET | Prescription | ORAL |
| 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 267MG | TABLET | Prescription | ORAL |