Ofev is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2014 to 2023. Out of these, 8 drug patents are active and 2 have expired. Ofev's patents will be open to challenges from 06 March, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 07, 2029. Details of Ofev's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6762180 | Substituted indolines which inhibit receptor tyrosine kinases |
Oct, 2025
(9 months from now) | Active |
| US7119093 | 3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate and the use thereof as a pharmaceutical composition |
Feb, 2024
(9 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9907756 (Pediatric) | Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative |
Dec, 2029
(4 years from now) | Active |
|
US10105323 (Pediatric) | Pharmaceutical dosage form for immediate release of an indolinone derivative |
Dec, 2029
(4 years from now) | Active |
| US9907756 | Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative |
Jun, 2029
(4 years from now) | Active |
| US10105323 | Pharmaceutical dosage form for immediate release of an indolinone derivative |
Jun, 2029
(4 years from now) | Active |
|
US10154990 (Pediatric) | Medicaments for the treatment or prevention of fibrotic diseases |
Jul, 2026
(1 year, 6 months from now) | Active |
|
US6762180 (Pediatric) | Substituted indolines which inhibit receptor tyrosine kinases |
Apr, 2026
(1 year, 3 months from now) | Active |
| US10154990 | Medicaments for the treatment or prevention of fibrotic diseases |
Jan, 2026
(1 year, 20 days from now) | Active |
| US7989474 | Use of Lck inhibitors for treatment of immunologic diseases |
Apr, 2024
(8 months 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 Ofev's patents.
Latest Legal Activities on Ofev's Patents
Given below is the list of recent legal activities going on the following patents of Ofev.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 04 Sep, 2023 | US7989474 |
| Maintenance Fee Reminder Mailed Critical | 20 Mar, 2023 | US7989474 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Jun, 2022 | US10154990 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Apr, 2022 | US10105323 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Sep, 2021 | US9907756 |
| Email Notification Critical | 05 Feb, 2020 | US7989474 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Feb, 2020 | US7989474 |
| Correspondence Address Change Critical | 04 Feb, 2020 | US7989474 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Jan, 2019 | US7989474 |
| Recordation of Patent Grant Mailed Critical | 18 Dec, 2018 | US10154990 |
FDA has granted several exclusivities to Ofev. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ofev, 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 Ofev.
Exclusivity Information
Ofev holds 7 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Ofev'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 |
| New Indication(I-805) | Sep 06, 2022 |
| New Indication(I-825) | Mar 09, 2023 |
| Orphan Drug Exclusivity(ODE-261) | Sep 06, 2026 |
| Pediatric Exclusivity(PED) | Mar 06, 2027 |
Several oppositions have been filed on Ofev'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 Ofev's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ofev patents.
Ofev's Oppositions Filed in EPO
Ofev has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 07, 2013, by Sandoz Ag. This opposition was filed on patent number EP05823930A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09757601A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP09757601A | Aug, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP09757601A | Aug, 2019 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP09757593A | Nov, 2018 | Zentiva Group, a.s. | Granted and Under Opposition |
| EP09757593A | Nov, 2018 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP09757593A | Nov, 2018 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP09757593A | Nov, 2018 | Galenicum Health S.L. | Granted and Under Opposition |
| EP05823930A | Aug, 2013 | SANDOZ AG | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Ofev 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 Ofev's family patents as well as insights into ongoing legal events on those patents.
Ofev's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ofev's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 07, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ofev Generics:
There are no approved generic versions for Ofev as of now.
How can I launch a generic of Ofev before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ofev's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ofev'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 Ofev -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 150 mg | 15 Oct, 2018 | 4 | 07 Jun, 2029 |
About Ofev
Ofev is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for slowing the decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease. Ofev uses Nintedanib Esylate as an active ingredient. Ofev was launched by Boehringer Ingelheim in 2014.
Approval Date:
Ofev was approved by FDA for market use on 15 October, 2014.
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 Ofev is 15 October, 2014, its NCE-1 date is estimated to be 06 March, 2026.
Active Ingredient:
Ofev uses Nintedanib Esylate as the active ingredient. Check out other Drugs and Companies using Nintedanib Esylate ingredient
Treatment:
Ofev is used for slowing the decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease.
Dosage:
Ofev is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | CAPSULE | Prescription | ORAL |
| EQ 150MG BASE | CAPSULE | Prescription | ORAL |