Monday, September 26, 2016

Lupron Depot


See also: Generic Lupron Depot-PED


Lupron Depot is a brand name of leuprolide, approved by the FDA in the following formulation(s):


LUPRON DEPOT (leuprolide acetate - injectable; injection)



  • Manufacturer: ABBOTT ENDOCRINE

    Approval date: December 22, 1995

    Strength(s): 22.5MG/VIAL [RLD]


  • Manufacturer: ABBOTT ENDOCRINE

    Approval date: May 30, 1997

    Strength(s): 30MG/VIAL [RLD]


  • Manufacturer: ABBOTT ENDOCRINE

    Approval date: June 17, 2011

    Strength(s): 45MG/VIAL


  • Manufacturer: ABBOTT LABS

    Approval date: January 26, 1989

    Strength(s): 7.5MG/VIAL [RLD]


  • Manufacturer: ABBOTT LABS

    Approval date: October 22, 1990

    Strength(s): 3.75MG/VIAL [RLD]


  • Manufacturer: ABBOTT LABS

    Approval date: March 7, 1997

    Strength(s): 11.25MG/VIAL [RLD]

Has a generic version of Lupron Depot been approved?


No. There is currently no therapeutically equivalent version of Lupron Depot available.


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




  • Prolonged release microcapsules
    Patent 5,480,656
    Issued: January 2, 1996
    Inventor(s): Okada; Hiroaki & Inoue; Yayoi & Ogawa; Yasuaki
    Assignee(s): Takeda Chemical Industries, Ltd.
    This invention provides a microcapsule designed for zero order release of a physiologically active polypeptide over a period of at least two months, which is produced by preparing a water-in-oil emulsion comprising an inner aqueous layer containing about 20 to 70% (w/w) of said polypeptide and an oil layer containing a copolymer or homopolymer having a weight-average molecular weight of 7,000 to 30,000, wherein the composition ratio of lactic acid/glycolic acid in the copolymer or homopolymer is 80/10 to 100/0, and then subjecting said water-in oil emulsion to microencapsulation.
    Patent expiration dates:

    • January 2, 2013




  • Method of producing sustained-release microcapsules
    Patent 5,575,987
    Issued: November 19, 1996
    Inventor(s): Kamei; Shigeru & Yamada; Minoru & Ogawa; Yasuaki
    Assignee(s): Takeda Chemical Industries, Ltd.
    A method of producing sustained-release microcapsules containing a biologically active substance from an W/O emulsion comprising an inner aqueous phase containing said biologically active substance and an external oil phase containing a biodegradable polymer, characterized in that microcapsules formed on microencapsulation of said biologically active substance with said biodegradable polymer are heated at a temperature not lower than the glass transition temperature of said biodegradable polymer but not so high as to cause aggregation of the microcapsules. This method enables the production of very useful sustained release microcapsules adapted to release a bologically active substance at a calculated rate over a protracted time period starting immediately following administration without an initial burst within one day following administration.
    Patent expiration dates:

    • September 2, 2013




  • Method for producing microcapsule
    Patent 5,631,020
    Issued: May 20, 1997
    Inventor(s): Okada; Hiroaki & Ogawa; Yasuaki & Yashiki; Takatsuka
    Assignee(s): Takeda Chemical Industries, Ltd.
    A microcapsule produced by preparing a water-in-oil emulsion comprising an inner aqueous layer containing said water-soluble drug and a drug retaining substance therefor and an oil layer containing a polymer substance, then thickening or solidifying said inner aqueous layer to a viscosity of not lower than about 5000 centiposes and finally subjecting the resulting emulsion to in water drying gives prolonged release of water-soluble drug.
    Patent expiration dates:

    • May 20, 2014




  • Method for producing microcapsule
    Patent 5,631,021
    Issued: May 20, 1997
    Inventor(s): Okada; Hiroaki & Ogawa; Yasuaki & Yashiki; Takatsuka
    Assignee(s): Takeda Chemical Industries, Ltd.
    A microcapsule produced by preparing a water-in-oil emulsion comprising an inner aqueous layer containing said water-soluble drug and a drug retaining substance therefor and an oil layer containing a polymer substance, then thickening or solidifying said inner aqueous layer to a viscosity of not lower than about 5000 centiposes and finally subjecting the resulting emulsion to in water drying gives prolonged release of water-soluble drug.
    Patent expiration dates:

    • May 20, 2014




  • Prolonged release microcapsules
    Patent 5,643,607
    Issued: July 1, 1997
    Inventor(s): Okada; Hiroaki & Inoue; Yayoi & Ogawa; Yasuaki
    Assignee(s): Takeda Chemical Industries, Ltd.
    This invention provides a microcapsule designed for zero order release of a physiologically active polypeptide over a period of at least two months, which is produced by preparing a water-in-oil emulsion comprising an inner aqueous layer containing about 20 to 70% (w/w) of said polypeptide and an oil layer containing a copolymer or homopolymer having a weight-average molecular weight of 7,000 to 30,000, wherein the composition ratio of lactic acid/glycolic acid in the copolymer or homopolymer is 80/10 to 100/0, and then subjecting said water-in oil emulsion to microencapsulation.
    Patent expiration dates:

    • January 2, 2013




  • Method of producing sustained-release microcapsules
    Patent 5,716,640
    Issued: February 10, 1998
    Inventor(s): Kamei; Shigeru & Yamada; Minoru & Ogawa; Yasuaki
    Assignee(s): Takeda Chemical Industries, Ltd.
    A method of producing sustained-release microcapsules containing a biologically active substance from an W/O emulsion comprising an inner aqueous phase containing said biologically active substance and an external oil phase containing a biodegradable polymer, characterized in that microcapsules formed on microencapsulation of said biologically active substance with said biodegradable polymer are heated at a temperature not lower than the glass transition temperature of said biodegradable polymer but not so high as to cause aggregation of the microcapsules. This method enables the production of very useful sustained release microcapsules adapted to release a bologically active substance at a calculated rate over a protracted time period starting immediately following administration without an initial burst within one day following administration.
    Patent expiration dates:

    • September 2, 2013




  • Sustained release microspheres and preparation thereof
    Patent 6,036,976
    Issued: March 14, 2000
    Inventor(s): Takechi; Nobuyuki & Ohtani; Seiji & Nagai; Akihiro
    Assignee(s): Takeda Chemical Industries, Ltd.
    Disclosed is a method of producing microspheres which comprises subjecting a w/o/w emulsion or o/w emulsion to an in-water drying method under the following conditions: 1) the amount of microspheres per m.sup.3 of an external aqueous phase is about 0.1 to about 500 kg, 2) the square root of the area (unit: m.sup.2) of the liquid surface in contact with the gas phase is about 0.2 to about 4.5 per the cube root of the volume (unit: m.sup.3) of an external aqueous phase, 3) the w/o/w emulsion or o/w emulsion is replaced at the replacement frequency of about 0.01 to about 10 times/minutes, 4) a gas is blown to the w/o/w emulsion or o/w emulsion at the gas transfer rate near the liquid surface of about 0.1 to about 300 m/second, and 5) the gas is replaced at the replacement frequency of not less than about 0.5 times/minutes; and the method of the present invention increases the rate of solvent removal from microspheres in in-water drying, reduces the amount of solvent in microspheres in a short time.
    Patent expiration dates:

    • December 13, 2016


    • December 13, 2016
      ✓ 
      Drug product




  • Controlled release composition and method of producing the same
    Patent 7,429,559
    Issued: September 30, 2008
    Inventor(s): Yamamoto; Kazumichi & Yamada; Akiko & Hata; Yoshio
    Assignee(s): Takeda Pharmaceutical Company Limited
    A controlled release composition containing a physiologically active substance in high content, suppressing the initial excess release, and achieving a stable release speed over a long period of time is provided. A controlled release composition comprising (1) a physiologically active substance or salt thereof in an amount of about 14% (w/w) to about 24% (w/w) based on the total composition weight, (2) hydroxynaphthoic acid selected from the group consisting of 3-hydroxy-2-naphthoic acid and 1-hydroxy-2-naphthoic acid or salt thereof, and (3) a lactic acid polymer or salt thereof having a weight-average molecular weight of 15000 to 50000 in which the content of polymers having molecular weights of 5000 or less is about 5% by weight or less, wherein the molar ratio of said hydroxynaphthoic acid or salt thereof to said physiologically active substance or salt thereof is from 3:4 to 4:3.
    Patent expiration dates:

    • December 13, 2016
      ✓ 
      Drug product



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:
    • June 17, 2014 - 45MG FOR 6 MONTH ADMINISTRATION

    • June 17, 2014 - NEW STRENGTH

See also...

  • Lupron Depot Consumer Information (Wolters Kluwer)
  • Lupron Depot Depot Suspension Consumer Information (Wolters Kluwer)
  • Lupron Depot Suspension Consumer Information (Wolters Kluwer)
  • Lupron Depot Consumer Information (Cerner Multum)
  • Lupron Depot Advanced Consumer Information (Micromedex)
  • Leuprolide Consumer Information (Wolters Kluwer)
  • Leuprolide Depot Suspension Consumer Information (Wolters Kluwer)
  • Leuprolide Implant Consumer Information (Wolters Kluwer)
  • Leuprolide Kit Consumer Information (Wolters Kluwer)
  • Leuprolide Suspension Consumer Information (Wolters Kluwer)
  • Leuprolide Consumer Information (Cerner Multum)
  • Leuprolide Intramuscular, Subcutaneous, Intradermal, Injection Advanced Consumer Information (Micromedex)
  • Leuprolide Acetate AHFS DI Monographs (ASHP)

No comments:

Post a Comment