Generic Lupron Depot-PED Availability

See also: Generic Lupron Depot

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

LUPRON DEPOT-PED (leuprolide acetate - injectable;injection)

  • Manufacturer: ABBVIE ENDOCRINE INC
    Approval date: April 16, 1993
    Strength(s): 7.5MG/VIAL [RLD]
  • Manufacturer: ABBVIE ENDOCRINE INC
    Approval date: January 21, 1994
    Strength(s): 11.25MG/VIAL [RLD], 15MG/VIAL [RLD]
  • Manufacturer: ABBVIE ENDOCRINE INC
    Approval date: August 15, 2011
    Strength(s): 11.25MG/VIAL [RLD], 30MG/VIAL [RLD]

Has a generic version of Lupron Depot-PED been approved?

No. There is currently no therapeutically equivalent version of Lupron Depot-PED available in the United States.

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

  • 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
      ✓ 
      Drug product
    • 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
      ✓ 
      Drug product
    • May 20, 2014
  • 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
      ✓ 
      Drug product
    • 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
      ✓ 
      Drug product
    • December 13, 2016
    • December 13, 2013

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:
    • August 15, 2014 - NEW PRODUCT
    • October 8, 2014 - INFORMATION TO THE CLINICAL STUDIES SECTION OF THE LUPRON DEPOT-PED,1-MONTH,BASED UPON THE PHASE 3/4 COMPLETED CLINICAL STUDY REPORT FOR STUDY M90-516, ENTITLED 'STUDY OF LUPRON DEPOT IN THE TREATMENT OF CENTRAL PRECOCIOUS PUBERTY'.

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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