Silenor is a brand name of doxepin, approved by the FDA in the following formulation(s):
SILENOR (doxepin hydrochloride - tablet; oral)
Manufacturer: SOMAXON
Approval date: March 17, 2010
Strength(s): EQ 3MG BASE, EQ 6MG BASE [RLD]
Has a generic version of Silenor been approved?
No. There is currently no therapeutically equivalent version of Silenor available.
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: About generic drugs.
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.
Treatment for insomnia
Patent 5,502,047
Issued: March 26, 1996
Inventor(s): Kavey; Neil B.
A method for the treatment of chronic insomnia is disclosed which involves the administration of low dosages of a compound selected from the pharmaceutically acceptable forms of doxepin, trimipramine, amitriptyline, trazodone and mixtures hereof.Patent expiration dates:
- March 26, 2013✓
- March 26, 2013
Pharmaceutical excipient having improved compressability
Patent 5,585,115
Issued: December 17, 1996
Inventor(s): Sherwood; Bob E. & Hunter; Edward A. & Staniforth; John H.
Assignee(s): Edward H. Mendell Co., Inc.
A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.Patent expiration dates:
- January 9, 2015✓
- January 9, 2015
Pharmaceutical excipient having improved compressibility
Patent 5,725,884
Issued: March 10, 1998
Inventor(s): Sherwood; Bob E. & Hunter; Edward A. & Staniforth; John H.
Assignee(s): Edward Mendell Co., Inc.
A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.Patent expiration dates:
- January 9, 2015✓
- January 9, 2015
Pharmaceutical excipient having improved compressibility
Patent 5,866,166
Issued: February 2, 1999
Inventor(s): Staniforth; John N. & Sherwood; Bob E. & Hunter; Edward A.
Assignee(s): Edward Mendell Co., Inc.
A composition, comprising (a) microcrystalline cellulose; and (b) a compressibility augmenting agent which (i) physically restricts the proximity of the interface between adjacent cellulose surfaces; or (ii) inhibits interactions between adjacent cellulose surfaces; or (iii) accomplishes both (i) and (ii) above, is disclosed. The composition is in the form of agglomerated particles of microcrystalline cellulose and the compressibility augmenting agent in intimate association with each other.Patent expiration dates:
- January 9, 2015✓
- January 9, 2015
Pharmaceutical formulations having improved disintegration and/or absorptivity
Patent 5,948,438
Issued: September 7, 1999
Inventor(s): Staniforth; John N. & Sherwood; Bob E. & Hunter; Edward A.
Assignee(s): Edward Mendell Co., Inc.
An oral solid dosage form, comprising a compressed tablet including an excipient comprising (a) microcrystalline cellulose; and (b) a compressibility augmenting agent which (I) physically restricts the proximity of the interface between adjacent cellulose surfaces (e.g., silicon dioxide); or (ii) inhibits interactions between adjacent cellulose surfaces (e.g., sodium lauryl sulfate); or (iii) accomplishes both (i) and (ii) above; together with an active agent, is disclosed which provides improved disintegration and/or absorptivity to the oral solid dosage form when orally administered to human patients. The excipient comprises agglomerated particles of said microcrystalline cellulose and said compressibility augmenting agent in intimate association with each other.Patent expiration dates:
- January 9, 2015✓
- January 9, 2015
Pharmaceutical excipient having improved compressibility
Patent 6,103,219
Issued: August 15, 2000
Inventor(s): Sherwood; Bob E. & Staniforth; John H. & Hunter; Edward A.
Assignee(s): Edward Mendell Co., Inc.
A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.Patent expiration dates:
- January 9, 2015✓
- January 9, 2015
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
Pharmaceutical excipient having improved compressibility
Patent 6,217,909
Issued: April 17, 2001
Inventor(s): Sherwood; Bob E. & Staniforth; John H. & Hunter; Edward A.
Assignee(s): Edward Mendell Co., Inc.
A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide.Patent expiration dates:
- January 9, 2015✓
- January 9, 2015
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
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- March 17, 2013 - NEW PRODUCT
See also...
- Silenor Consumer Information (Drugs.com)
- Silenor Consumer Information (Wolters Kluwer)
- Silenor Consumer Information (Cerner Multum)
- Silenor Advanced Consumer Information (Micromedex)
- Doxepin Consumer Information (Wolters Kluwer)
- Doxepin Capsules Consumer Information (Wolters Kluwer)
- Doxepin Concentrate Consumer Information (Wolters Kluwer)
- Doxepin Consumer Information (Cerner Multum)
- Doxepin Advanced Consumer Information (Micromedex)
- Doxepin Hydrochloride AHFS DI Monographs (ASHP)
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