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
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.
Latest 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 |
|---|---|---|
 | ||
| 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 |
Erlotinib Hydrochloride's 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.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Discontinued | ORAL | N/A | Jul 2, 2020 |
| EQ 100MG BASE | tablet | Discontinued | ORAL | N/A | Jul 2, 2020 |
| EQ 150MG BASE | tablet | Discontinued | ORAL | N/A | Jul 2, 2020 |
2. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Jul 8, 2021 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Jul 8, 2021 |
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | Jul 8, 2021 |
Manufacturing Plant Locations New
Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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3. APOTEX
Apotex Inc has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
| Country | City | Firm Name | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Canada |
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| India |
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4. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | Sep 13, 2024 |
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Sep 13, 2024 |
5. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Discontinued | ORAL | N/A | Jun 22, 2022 |
| EQ 150MG BASE | tablet | Discontinued | ORAL | N/A | Jun 22, 2022 |
| EQ 100MG BASE | tablet | Discontinued | ORAL | N/A | Jun 22, 2022 |
Manufacturing Plant Locations New
Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| India |
| |||||||
6. HETERO LABS LTD V
Hetero Labs Ltd Unit V has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | May 24, 2024 |
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | May 24, 2024 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | May 24, 2024 |
7. MSN
Msn Laboratories Private Ltd has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Msn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | May 10, 2021 |
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | May 10, 2021 |
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | May 10, 2021 |
Manufacturing Plant Locations New
Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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8. NATCO PHARMA LTD
Natco Pharma Ltd has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Natco Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
| EQ 25MG BASE | tablet | Discontinued | ORAL | N/A | Nov 5, 2019 |
| EQ 150MG BASE | tablet | Discontinued | ORAL | N/A | Nov 5, 2019 |
Manufacturing Plant Locations New
Natco Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Natco Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| India |
| |||||
9. RISING
Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Jun 11, 2014 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Jun 11, 2014 |
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | Jun 11, 2014 |
Manufacturing Plant Locations New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Mexico |
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| India |
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10. SHILPA
Shilpa Medicare Ltd has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Shilpa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
Manufacturing Plant Locations New
Shilpa's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Shilpa as present at those locations.
| Country | City | Firm Name | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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11. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | Nov 5, 2019 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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12. TEVA PHARMS USA INC
Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Aug 28, 2015 |
| EQ 150MG BASE | tablet | Prescription | ORAL | AB | Aug 28, 2015 |
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Nov 9, 2020 |
13. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Erlotinib Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 25MG BASE | tablet | Prescription | ORAL | AB | Apr 16, 2020 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Apr 16, 2020 |
| EQ 150MG BASE
(reference standard) | tablet | Prescription | ORAL | AB | Apr 16, 2020 |