Erlotinib Hydrochloride Patent Expiration

Erlotinib Hydrochloride 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. It was first introduced by Osi Pharmaceuticals Llc in its drug Tarceva on Nov 18, 2004. 14 different companies have introduced drugs containing Erlotinib Hydrochloride.


Erlotinib Hydrochloride Patents

Given below is the list of patents protecting Erlotinib Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Tarceva US6900221

(Pediatric)

Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof May 09, 2021

(Expired)

Osi Pharms
Tarceva US7087613

(Pediatric)

Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride May 09, 2021

(Expired)

Osi Pharms
Tarceva US6900221 Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof Nov 09, 2020

(Expired)

Osi Pharms
Tarceva US7087613 Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride Nov 09, 2020

(Expired)

Osi Pharms
Tarceva US5747498

(Pediatric)

Alkynyl and azido-substituted 4-anilinoquinazolines May 08, 2019

(Expired)

Osi Pharms
Tarceva USRE41065

(Pediatric)

Alkynl and azido-substituted 4-anilinoquinazolines May 08, 2019

(Expired)

Osi Pharms
Tarceva US5747498 Alkynyl and azido-substituted 4-anilinoquinazolines Nov 08, 2018

(Expired)

Osi Pharms
Tarceva USRE41065 Alkynl and azido-substituted 4-anilinoquinazolines Nov 08, 2018

(Expired)

Osi Pharms



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 Erlotinib Hydrochloride's patents.

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

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


Erlotinib Hydrochloride's Family Patents

Family Patents

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Erlotinib Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Erlotinib Hydrochloride. The first generic version for Erlotinib Hydrochloride was by Rising Pharma Holdings Inc and was approved on Jun 11, 2014. And the latest generic version is by Chartwell Rx Sciences Llc and was approved on Sep 13, 2024.

Given below is the list of companies who have filed for Erlotinib Hydrochloride generic, along with the locations of their manufacturing plants worldwide.