Generic Silenor Availability
Last updated on Jun 11, 2025.
Silenor is a brand name of doxepin, approved by the FDA in the following formulation(s):
SILENOR (doxepin hydrochloride - tablet;oral)
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Manufacturer: CURRAX
Approval date: March 17, 2010
Strength(s): EQ 3MG BASE [RLD] [AB], EQ 6MG BASE [RLD] [AB]
Is there a generic version of Silenor available?
A generic version of Silenor has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Silenor and have been approved by the FDA:
doxepin hydrochloride tablet;oral
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Manufacturer: ACTAVIS ELIZABETH
Approval date: July 26, 2013
Strength(s): EQ 3MG BASE [AB], EQ 6MG BASE [AB] -
Manufacturer: RK PHARMA
Approval date: January 20, 2016
Strength(s): EQ 3MG BASE [AB], EQ 6MG BASE [AB] -
Manufacturer: STRIDES PHARMA
Approval date: July 24, 2020
Strength(s): EQ 3MG BASE [AB], EQ 6MG BASE [AB] -
Manufacturer: ZYDUS LIFESCIENCES
Approval date: August 16, 2023
Strength(s): EQ 3MG BASE [AB], EQ 6MG BASE [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Silenor. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Methods of using low-dose doxepin for the improvement of sleep
Patent 10,238,620
Issued: March 26, 2019
Inventor(s): Rogowski; Roberta L. et al.
Assignee(s): Pernix Sleep, Inc. (Morristown, NJ); ProCom One, Inc. (San Marcos, TX)Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Patent expiration dates:
- May 18, 2027✓
- May 18, 2027
-
Low-dose doxepin formulations and methods of making and using the same
Patent 10,548,871
Issued: February 4, 2020
Inventor(s): Schioppi Luigi & Dorsey Brian Talmadge & Skinner Michael & Carter John & Mansbach Robert & Jochelson Philip & Rogowski Roberta L. & Casseday Cara Baron & Perry Meredith & Knox Bryan
Assignee(s): Currax Pharmaceuticals LLCThe invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Patent expiration dates:
- April 11, 2028✓
- April 11, 2028
-
Methods of improving the pharmacokinetics of doxepin
Patent 10,653,660
Issued: May 19, 2020
Inventor(s): Casseday Cara Baron & Ludington Elizabeth & Skinner Michael & Dubé Susan E. & Rogowski Roberta L. & Jochelson Philip & Mansbach Robert
Assignee(s): Currax Pharmaceuticals LLCMethods of improving the pharmacokinetics of doxepin in a patient.
Patent expiration dates:
- July 20, 2027✓
- July 20, 2027
-
Methods of using low-dose doxepin for the improvement of sleep
Patent 10,653,662
Issued: May 19, 2020
Inventor(s): Rogowski; Roberta L. et al.
Assignee(s): Currax Pharmaceuticals LLC (Morristown, NJ); ProCom One, Inc. (Steamboat Springs, CO)Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Patent expiration dates:
- May 18, 2027✓
- May 18, 2027
-
Low-dose doxepin formulations and methods of making and using the same
Patent 11,096,920
Issued: August 24, 2021
Inventor(s): Schioppi Luigi & Dorsey Brian Talmadge & Skinner Michael & Carter John & Mansbach Robert & Jochelson Philip & Rogowski Roberta L. & Casseday Cara Baron & Perry Meredith & Knox Bryan
Assignee(s): Currax Pharmaceuticals LLCThe invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Patent expiration dates:
- April 11, 2028✓
- April 11, 2028
-
Methods of improving the pharmacokinetics of doxepin
Patent 11,110,074
Issued: September 7, 2021
Inventor(s): Casseday Cara Baron & Ludington Elizabeth & Skinner Michael & Dubé Susan E. & Rogowski Roberta L. & Jochelson Philip & Mansbach Robert
Assignee(s): Currax Pharmaceuticals LLCMethods of improving the pharmacokinetics of doxepin in a patient.
Patent expiration dates:
- July 20, 2027✓
- July 20, 2027
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Low-dose doxepin for treatment of sleep disorders in elderly patients
Patent 11,234,954
Issued: February 1, 2022
Inventor(s): Rogowski Roberta L. & Dube Susan Ellen & Jochelson Philip & Kavey Neil Barton
Assignee(s): Currax Pharmaceuticals LLCMethods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe for elderly individuals.
Patent expiration dates:
- January 18, 2028✓
- January 18, 2028
-
Methods of using low-dose doxepin for the improvement of sleep
Patent 12,083,090
Issued: September 10, 2024
Inventor(s): Rogowski; Roberta L. et al.
Assignee(s): Currax Pharmaceuticals LLC (Morristown, NJ); ProCom One, Inc. (San Marcos, TX)Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Patent expiration dates:
- May 18, 2027✓
- May 18, 2027
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Methods of improving the pharmacokinetics of doxepin
Patent 7,915,307
Issued: March 29, 2011
Inventor(s): Casseday; Cara Baron et al.
Assignee(s): Somaxon Pharmaceuticals, Inc. (San Diego, CA)Methods of improving the pharmacokinetics of doxepin in a patient.
Patent expiration dates:
- August 24, 2027✓
- August 24, 2027
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Methods of using low-dose doxepin for the improvement of sleep
Patent 8,513,299
Issued: August 20, 2013
Inventor(s): Rogowski; Roberta L. et al.
Assignee(s): Pernix Sleep, Inc. (The Woodlands, TX); Procom One, Inc. (San Marcos, TX)Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Patent expiration dates:
- September 7, 2030✓
- September 7, 2030
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Methods of using low-dose doxepin for the improvement of sleep
Patent 9,107,898
Issued: August 18, 2015
Inventor(s): Rogowski Roberta L. & Dube Susan E. & Jochelson Philip & Kavey Neil B.
Assignee(s): Pernix Sleep, Inc.Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Patent expiration dates:
- May 1, 2028✓
- May 1, 2028
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Methods of using low-dose doxepin for the improvement of sleep
Patent 9,486,437
Issued: November 8, 2016
Inventor(s): Rogowski; Roberta L. et al.
Assignee(s): Pernix Sleep, Inc. (Morristown, NJ); ProCom One, Inc. (San Marcos, TX)Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Patent expiration dates:
- May 18, 2027✓
- May 18, 2027
-
Low-dose doxepin formulations and methods of making and using the same
Patent 9,532,971
Issued: January 3, 2017
Inventor(s): Schioppi Luigi & Dorsey Brian Talmadge & Skinner Michael & Carter John & Mansbach Robert & Jochelson Philip & Rogowski Roberta L. & Casseday Cara Baron & Perry Meredith & Knox Bryan
Assignee(s): Pernix Sleep, Inc.The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Patent expiration dates:
- June 1, 2029✓
- June 1, 2029
-
Methods of improving the pharmacokinetics of doxepin
Patent 9,572,814
Issued: February 21, 2017
Inventor(s): Casseday Cara Baron & Ludington Elizabeth & Skinner Michael & Dubé Susan E. & Rogowski Roberta L. & Jochelson Philip & Mansbach Robert
Assignee(s): Pernix Sleep, Inc.Methods of improving the pharmacokinetics of doxepin in a patient.
Patent expiration dates:
- July 20, 2027✓
- July 20, 2027
-
Methods of using low-dose doxepin for the improvement of sleep
Patent 9,861,607
Issued: January 9, 2018
Inventor(s): Rogowski; Roberta L. et al.
Assignee(s): Procom One, Inc. (San Marcos, TX); Pernix Sleep, Inc. (Morristown, NJ)Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Patent expiration dates:
- May 18, 2027✓
- May 18, 2027
-
Low-dose doxepin formulations and methods of making and using the same
Patent 9,907,780
Issued: March 6, 2018
Inventor(s): Schioppi Luigi & Dorsey Brian Talmadge & Skinner Michael & Carter John & Mansbach Robert & Jochelson Philip & Rogowski Roberta L. & Casseday Cara Baron & Perry Meredith & Knox Bryan
Assignee(s): Pernix Sleep, Inc.The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Patent expiration dates:
- April 11, 2028✓
- April 11, 2028
More about Silenor (doxepin)
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- Reviews (127)
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- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous anxiolytics, sedatives and hypnotics
- Breastfeeding
- En español
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
| AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
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