Tarceva Patent Expiration

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

(3 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

(3 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

(5 years ago)

Expired
US5747498 Alkynyl and azido-substituted 4-anilinoquinazolines
Nov, 2018

(5 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.

Given below is the list of recent legal activities going on the following patents of Tarceva.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 08 Feb, 2018 US7087613
Patent Issue Date Used in PTA Calculation 08 Aug, 2006 US7087613
Recordation of Patent Grant Mailed 08 Aug, 2006 US7087613
Issue Notification Mailed 19 Jul, 2006 US7087613
Application Is Considered Ready for Issue 05 Jul, 2006 US7087613
Dispatch to FDC 05 Jul, 2006 US7087613
Issue Fee Payment Received 07 Jun, 2006 US7087613
Issue Fee Payment Verified 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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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


Family Patents

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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 Generics:

Erlotinib Hydrochloride is the generic name for the brand Tarceva. 12 different companies have already filed for the generic of Tarceva, with Accord Hlthcare 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
Vizimpro used for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.





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