Generic Silenor Availability
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: PERNIX THERAPS LLC
Approval date: March 17, 2010
Strength(s): EQ 3MG BASE [RLD], EQ 6MG BASE [RLD]
Has a generic version of Silenor been approved?
No. There is currently no therapeutically equivalent version of Silenor available in the United States.
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 FAQs.
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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Treatment of transient and short term insomnia
Patent 6,211,229
Issued: April 3, 2001
Inventor(s): Kavey; Neil B.
The invention is directed to a method for the treatment of a patient suffering from transient or short term insomnia. The claimed method comprises the administration of a compound selected from the group consisting of the pharmaceutically acceptable forms of doxepin, amitriptyline, trimipramine, trazodone and mixtures thereof in dosages ranging from about 0.5 to about 20.0 milligrams.Patent expiration dates:- February 17, 2020✓
- February 17, 2020
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Methods of improving the pharmacokinetics of doxepin
Patent 7,915,307
Issued: March 29, 2011
Inventor(s): Casseday; Cara Baron & Ludington; Elizabeth & Skinner; Michael & Dubé; Susan & Rogowski; Roberta L. & Jochelson; Philip & Mansbach; Robert
Assignee(s): Somaxon Pharmaceuticals, Inc.
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
Assignee(s): Pernix Sleep, Inc. Procom One, 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:- 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
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
Assignee(s): Pernix Sleep, Inc. ProCom One, 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 18, 2027✓
- May 18, 2027
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Low-dose doxepin formulations and methods of making and using the same
Patent 9,532,971
Issued: January 3, 2017
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
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Methods of improving the pharmacokinetics of doxepin
Patent 9,572,814
Issued: February 21, 2017
Assignee(s): Pernix Sleep, Inc.
Methods of improving the pharmacokinetics of doxepin in a patient.Patent expiration dates:- July 20, 2027✓
- July 20, 2027
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Methods of using low-dose doxepin for the improvement of sleep
Patent 9,861,607
Issued: January 9, 2018
Assignee(s): Procom One, Inc. 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 18, 2027✓
- May 18, 2027
More about Silenor (doxepin)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 103 Reviews – Add your own review/rating
- Drug class: miscellaneous anxiolytics, sedatives and hypnotics
Consumer resources
Other brands: Sinequan
Professional resources
Related treatment guides
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. |
