Generic Oleptro Availability

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

OLEPTRO (trazodone hydrochloride - tablet, extended release;oral)

  • Manufacturer: ANGELINI PHARMA
    Approval date: February 2, 2010
    Strength(s): 150MG [RLD], 300MG

Has a generic version of Oleptro been approved?

No. There is currently no therapeutically equivalent version of Oleptro available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Oleptro. 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.

  • Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
    Patent 6,607,748
    Issued: August 19, 2003
    Inventor(s): Vincent; Lenaerts & Roland Herwig Friedrich; Beck & Elsie; Van Bogaert & Francois; Chouinard & Reiner; Höpcke & Cyril; Désévaux
    The present invention relates to a novel form of cross-linked high amylose starch and processes for its manufacture. Such cross-linked high amylose starch is useful as an excipient in a controlled-release pharmaceutical formulation when compressed with pharmaceutical agent(s) in a tablet. Such cross-linked high amylose starch is prepared by (a) cross-linking and chemical modification of high amylose starch, (b) gelatinization, and (c) drying to obtain a powder of said controlled release excipient. In a preferred embodiment, such cross-linked high amylose starch is prepared in the following steps: (1) granular cross-linking and additional chemical modification (e.g., hydroxypropylation) of high-amylose starch; (2) thermal gelatinization of the starch from step (1); and (3) drying the starch from step (2) to yield a powder capable of being used as a controlled release excipient.
    Patent expiration dates:
    • June 29, 2020
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      Drug product
  • Trazodone composition for once a day administration
    Patent 7,829,120
    Issued: November 9, 2010
    Inventor(s): Gervais; Sonia & Smith; Damon & Rahmouni; Miloud & Contamin; Pauline & Ouzerourou; Rachid & Ma; My Linh & Ferrada; Angela & Soulhi; Fouzia
    Assignee(s): Labopharm Inc. Labopharm Europe Limited Labopharm (Barbados) Limited
    The invention relates to a once a day formulation of trazodone or a trazodone derivative. The formulation contains trazodone or a trazodone derivative and a controlled release excipient so that, once administered orally, the trazodone or the trazodone derivative is maintained at a therapeutic plasma concentration from at least 1 hour to at least 24 hours after initial administration. After administration, the initial therapeutic action takes effect within the first hour and lasts at least about 24 hours. This therapeutic effect remains relatively and substantially stable for the remaining period of 24 hours. The formulations can be used for treating depression and/or sleeping disorders.
    Patent expiration dates:
    • March 27, 2027
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      Patent use: METHOD OF TREATING DEPRESSION
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      Drug product
  • Trazodone and trazodone hydrochloride in purified form
    Patent 8,133,893
    Issued: March 13, 2012
    Inventor(s): Marchetti; Marcello & Iacoangeli; Tommaso & Ciottoli; Giovanni Battista & Biondi; Giuseppe
    Assignee(s): Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
    A process of production of trazodone or trazodone hydrochloride that comprises the steps of: (a) preparing an organic phase comprising trazodone in at least one organic solvent; (b) preparing an aqueous phase comprising at least one basic compound; (c) mixing said aqueous phase with said organic phase; (d) heating at a temperature of at least 40° C. for at least 30 minutes; (e) recovering said trazodone; and, optionally, (f) treating said trazodone with hydrochloric acid to obtain trazodone hydrochloride. Trazodone or trazodone hydrochloride comprising less than 15 ppm of alkylating substances, and a pharmaceutical composition comprising said trazodone hydrochloride.
    Patent expiration dates:
    • March 13, 2029
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      Drug substance
      ✓ 
      Drug product

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.
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