Tarceva is a drug owned by Osi Pharmaceuticals Llc. It is protected by 8 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 09, 2021. Details of Tarceva'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). | |||
|
US6900221 (Pediatric) | Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof |
May, 2021
(3 years ago) |
Expired
|
|
US7087613 (Pediatric) | Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride |
May, 2021
(3 years ago) |
Expired
|
| US6900221 | Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof |
Nov, 2020
(4 years ago) |
Expired
|
| US7087613 | Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride |
Nov, 2020
(4 years ago) |
Expired
|
|
US5747498 (Pediatric) | Alkynyl and azido-substituted 4-anilinoquinazolines |
May, 2019
(5 years ago) |
Expired
|
|
USRE41065 (Pediatric) | Alkynl and azido-substituted 4-anilinoquinazolines |
May, 2019
(5 years ago) |
Expired
|
| USRE41065 | Alkynl and azido-substituted 4-anilinoquinazolines |
Nov, 2018
(6 years ago) |
Expired
|
| US5747498 | Alkynyl and azido-substituted 4-anilinoquinazolines |
Nov, 2018
(6 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 Tarceva's patents.
Latest Legal Activities on Tarceva's Patents
Given below is the list of recent legal activities going on the following patents of Tarceva.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2018 | US7087613 |
| Patent Issue Date Used in PTA Calculation Critical | 08 Aug, 2006 | US7087613 |
| Recordation of Patent Grant Mailed Critical | 08 Aug, 2006 | US7087613 |
| Issue Notification Mailed Critical | 19 Jul, 2006 | US7087613 |
| Application Is Considered Ready for Issue Critical | 05 Jul, 2006 | US7087613 |
| Dispatch to FDC | 05 Jul, 2006 | US7087613 |
| Issue Fee Payment Received Critical | 07 Jun, 2006 | US7087613 |
| Issue Fee Payment Verified Critical | 07 Jun, 2006 | US7087613 |
| Correction - Drawing NOT Required | 09 Mar, 2006 | US7087613 |
| Mail Formal Drawings Required | 09 Mar, 2006 | US7087613 |
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 Tarceva and ongoing litigations to help you estimate the early arrival of Tarceva generic.
Tarceva's Litigations
Tarceva been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 28, 2016, against patent number US6900221. The petitioner Apotex, Inc., challenged the validity of this patent, with OSI Pharmaceuticals, LLC as the respondent. Click below to track the latest information on how companies are challenging Tarceva's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6900221 | June, 2016 |
FWD Entered
(08 Jan, 2018) | OSI Pharmaceuticals, LLC | Apotex, Inc. |
FDA has granted some exclusivities to Tarceva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tarceva, 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 Tarceva.
Exclusivity Information
Tarceva holds 7 exclusivities. All of its exclusivities have expired in 2019. Details of Tarceva's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-79) | Sep 19, 2011 |
| New Indication(I-624) | Apr 16, 2013 |
| New Indication(I-671) | May 14, 2016 |
| Pediatric Exclusivity(PED) | Nov 14, 2016 |
| New Dosing Schedule(D-164) | May 20, 2019 |
| M(M-181) | Jun 01, 2019 |
| M(M-190) | Oct 18, 2019 |
US patents provide insights into the exclusivity only within the United States, but Tarceva 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 Tarceva's family patents as well as insights into ongoing legal events on those patents.
Tarceva's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tarceva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 09, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tarceva Generic API suppliers:
Erlotinib Hydrochloride is the generic name for the brand Tarceva. 13 different companies have already filed for the generic of Tarceva, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tarceva's generic
How can I launch a generic of Tarceva before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tarceva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tarceva'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 Tarceva -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 150 mg | 18 Nov, 2008 | 2 | 11 Jun, 2014 | 09 Nov, 2020 | Eligible |
| 25 mg | 18 Nov, 2008 | 1 | 11 Jun, 2014 | 09 Nov, 2020 | Eligible |
Alternative Brands for Tarceva
Tarceva which is used for treating locally advanced unresectable or metastatic pancreatic cancer, metastatic non-small cell lung cancer with specific mutations, and maintenance treatment in lung cancer patients who have not progressed on platinum-based chemotherapy., has several other brand drugs in the same treatment category . 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 | ||
|---|---|---|---|---|
| Pfizer |
| |||
About Tarceva
Tarceva is a drug owned by Osi Pharmaceuticals Llc. It is used for treating locally advanced unresectable or metastatic pancreatic cancer, metastatic non-small cell lung cancer with specific mutations, and maintenance treatment in lung cancer patients who have not progressed on platinum-based chemotherapy. Tarceva uses Erlotinib Hydrochloride as an active ingredient. Tarceva was launched by Osi Pharms in 2004.
Approval Date:
Tarceva was approved by FDA for market use on 18 November, 2004.
Active Ingredient:
Tarceva uses Erlotinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Erlotinib Hydrochloride ingredient
Treatment:
Tarceva is used for treating locally advanced unresectable or metastatic pancreatic cancer, metastatic non-small cell lung cancer with specific mutations, and maintenance treatment in lung cancer patients who have not progressed on platinum-based chemotherapy.
Dosage:
Tarceva is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |