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Generic Silenor Availability

Silenor is a brand name of doxepin, approved by the FDA in the following formulation(s):

SILENOR (doxepin hydrochloride - tablet;oral)

  • Manufacturer: PERNIX THERAPS LLC
    Approval date: March 17, 2010
    Strength(s): EQ 3MG BASE [AB], EQ 6MG BASE [RLD] [AB]

Has a generic version of Silenor been approved?

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

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: July 26, 2013
    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: 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.

  • 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Patent use: TREATMENT OF INSOMNIA
  • 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Patent use: TREATMENT OF INSOMNIA
  • 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:
    • April 14, 2030
      ✓ 
      Patent use: TREATMENT OF INSOMNIA

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.
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