Efavirenz Patent Expiration
Efavirenz is used for managing HIV infection in combination with other antiviral drugs. It was first introduced by Bristol Myers Squibb Co
Efavirenz Patents
Given below is the list of patents protecting Efavirenz, 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 |
|---|---|---|---|---|
| Sustiva |
US6238695 (Pediatric) | Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants |
Oct 06, 2019
(Expired) | Bristol Myers Squibb |
| Sustiva |
US6555133 (Pediatric) | Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants |
Oct 06, 2019
(Expired) | Bristol Myers Squibb |
| Sustiva | US6238695 | Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants |
Apr 06, 2019
(Expired) | Bristol Myers Squibb |
| Sustiva | US6555133 | Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants |
Apr 06, 2019
(Expired) | Bristol Myers Squibb |
| Sustiva |
US6639071 (Pediatric) | Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one |
Aug 14, 2018
(Expired) | Bristol Myers Squibb |
| Sustiva |
US6939964 (Pediatric) | Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one |
Jul 20, 2018
(Expired) | Bristol Myers Squibb |
| Sustiva | US6639071 | Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one |
Feb 14, 2018
(Expired) | Bristol Myers Squibb |
| Sustiva | US6939964 | Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one |
Jan 20, 2018
(Expired) | Bristol Myers Squibb |
| Sustiva |
US5663169 (Pediatric) | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Mar 02, 2015
(Expired) | Bristol Myers Squibb |
| Sustiva | US5663169 | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Sep 02, 2014
(Expired) | Bristol Myers Squibb |
| Sustiva |
US5519021 (Pediatric) | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Nov 21, 2013
(Expired) | Bristol Myers Squibb |
| Sustiva | US5519021 | Benzoxazinones as inhibitors of HIV reverse transcriptase |
May 21, 2013
(Expired) | Bristol Myers Squibb |
| Sustiva | US5811423 | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Aug 07, 2012
(Expired) | Bristol Myers Squibb |
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 Efavirenz's patents.
Latest Legal Activities on Efavirenz's Patents
Given below is the list recent legal activities going on the following patents of Efavirenz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 29 Apr, 2003 | US6555133 |
| Recordation of Patent Grant Mailed Critical | 29 Apr, 2003 | US6555133 |
| Issue Notification Mailed Critical | 10 Apr, 2003 | US6555133 |
| Receipt into Pubs | 14 Mar, 2003 | US6555133 |
| Receipt into Pubs | 06 Mar, 2003 | US6555133 |
| Receipt into Pubs | 03 Mar, 2003 | US6555133 |
| Application Is Considered Ready for Issue Critical | 28 Feb, 2003 | US6555133 |
| Issue Fee Payment Received Critical | 19 Feb, 2003 | US6555133 |
| Issue Fee Payment Verified Critical | 19 Feb, 2003 | US6555133 |
| Receipt into Pubs | 11 Feb, 2003 | US6555133 |
Efavirenz's Family Patents
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Efavirenz Generic API Manufacturers
Several generic applications have been filed for Efavirenz. The first generic version for Efavirenz was by Mylan Pharmaceuticals Inc and was approved on Feb 17, 2016. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on May 10, 2024.
Given below is the list of companies who have filed for Efavirenz generic, along with the locations of their manufacturing plants worldwide.
1. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Efavirenz. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 200MG
(reference standard) | capsule | Prescription | ORAL | N/A | Dec 15, 2017 |
| 50MG | capsule | Prescription | ORAL | N/A | Dec 15, 2017 |
| 100MG | capsule | Prescription | ORAL | N/A | Dec 15, 2017 |
| 600MG | tablet | Discontinued | ORAL | N/A | Aug 30, 2018 |
Manufacturing Plant Locations New
Aurobindo Pharma'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 Aurobindo Pharma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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2. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 1 generic for Efavirenz. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Sep 21, 2018 |
Manufacturing Plant Locations New
Aurobindo 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 Aurobindo Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
3. CIPLA
Cipla Ltd has filed for 1 generic for Efavirenz. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Jun 15, 2018 |
Manufacturing Plant Locations New
Cipla'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 Cipla as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||
4. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 1 generic for Efavirenz. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG
(reference standard) | tablet | Prescription | ORAL | AB | Apr 27, 2018 |
5. MACLEODS PHARMS LTD
Macleods Pharmaceuticals Ltd has filed for 1 generic for Efavirenz. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | May 10, 2024 |
6. MYLAN
Mylan Pharmaceuticals Inc has filed for 1 generic for Efavirenz. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Discontinued | ORAL | N/A | Feb 17, 2016 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
| |||||||||||||||||
| Ireland |
| |||||||||||||||||
7. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 1 generic for Efavirenz. Given below are the details of the strengths of this generic introduced by Strides Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Discontinued | ORAL | N/A | Jun 16, 2021 |
Manufacturing Plant Locations New
Strides Pharma'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 Strides Pharma as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
| |||||
| India |
| |||||