Doxepin Hydrochloride Patent Expiration

Doxepin Hydrochloride is Used for treating insomnia. It was first introduced by Pfizer Laboratories Div Pfizer Inc in its drug Sinequan on Approved Prior to Jan 1, 1982. Other drugs containing Doxepin Hydrochloride are Silenor, Doxepin Hydrochloride, Zonalon. 40 different companies have introduced drugs containing Doxepin Hydrochloride.


Doxepin Hydrochloride Patents

Given below is the list of patents protecting Doxepin 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
Silenor US8513299 Methods of using low-dose doxepin for the improvement of sleep Sep 07, 2030 Currax
Silenor US9532971 Low-dose doxepin formulations and methods of making and using the same Jun 01, 2029 Currax
Silenor US9107898 Methods of using low-dose doxepin for the improvement of sleep May 01, 2028 Currax
Silenor US10548871 Low-dose doxepin formulations and methods of making and using the same Apr 11, 2028 Currax
Silenor US11096920 Low-dose doxepin formulations and methods of making and using the same Apr 11, 2028 Currax
Silenor US9907780 Low-dose doxepin formulations and methods of making and using the same Apr 11, 2028 Currax
Silenor US11234954 Low-dose doxepin for treatment of sleep disorders in elderly patients Jan 18, 2028 Currax
Silenor US7915307 Methods of improving the pharmacokinetics of doxepin Aug 24, 2027 Currax
Silenor US10653660 Methods of improving the pharmacokinetics of doxepin Jul 20, 2027 Currax
Silenor US11110074 Methods of improving the pharmacokinetics of doxepin Jul 20, 2027 Currax
Silenor US9572814 Methods of improving the pharmacokinetics of doxepin Jul 20, 2027 Currax
Silenor US10238620 Methods of using low-dose doxepin for the improvement of sleep May 18, 2027 Currax
Silenor US10653662 Methods of using low-dose doxepin for the improvement of sleep May 18, 2027 Currax
Silenor US12083090 Methods of using low-dose doxepin for the improvement of sleep May 18, 2027 Currax
Silenor US9486437 Methods of using low-dose doxepin for the improvement of sleep May 18, 2027 Currax
Silenor US9861607 Methods of using low-dose doxepin for the improvement of sleep May 18, 2027 Currax
Silenor US6211229 Treatment of transient and short term insomnia Feb 17, 2020

(Expired)

Currax
Silenor US5585115 Pharmaceutical excipient having improved compressability Jan 09, 2015

(Expired)

Currax
Silenor US5725884 Pharmaceutical excipient having improved compressibility Jan 09, 2015

(Expired)

Currax
Silenor US5866166 Pharmaceutical excipient having improved compressibility Jan 09, 2015

(Expired)

Currax
Silenor US5948438 Pharmaceutical formulations having improved disintegration and/or absorptivity Jan 09, 2015

(Expired)

Currax
Silenor US6103219 Pharmaceutical excipient having improved compressibility Jan 09, 2015

(Expired)

Currax
Silenor US6217909 Pharmaceutical excipient having improved compressibility Jan 09, 2015

(Expired)

Currax
Silenor US5502047 Treatment for insomnia Mar 26, 2013

(Expired)

Currax



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 Doxepin Hydrochloride's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Yr, Small Entity 19 Jun, 2024 US9532971
Payment of Maintenance Fee, 8th Yr, Small Entity 24 Apr, 2024 US9486437
Payment of Maintenance Fee, 4th Yr, Small Entity 01 Nov, 2023 US10653660
Payment of Maintenance Fee, 4th Yr, Small Entity 01 Nov, 2023 US10653662
Payment of Maintenance Fee, 4th Yr, Small Entity 19 Jul, 2023 US10548871
Payment of Maintenance Fee, 8th Yr, Small Entity 01 Feb, 2023 US9107898
Payment of Maintenance Fee, 4th Yr, Small Entity 14 Sep, 2022 US10238620
Payment of Maintenance Fee, 12th Yr, Small Entity 14 Sep, 2022 US7915307(Litigated)
Patent Issue Date Used in PTA Calculation 01 Feb, 2022 US11234954
Recordation of Patent Grant Mailed 01 Feb, 2022 US11234954


Doxepin Hydrochloride's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

Doxepin Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Doxepin Hydrochloride. The first generic version for Doxepin Hydrochloride was by Mylan Pharmaceuticals Inc and was approved on May 13, 1986. And the latest generic version is by Taro Pharmaceutical Industries Ltd and was approved on Aug 6, 2025.

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