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: ABBOTT ENDOCRINE
Approval date: April 16, 1993
Strength(s): 7.5MG/VIAL [RLD]
Manufacturer: ABBOTT ENDOCRINE
Approval date: January 21, 1994
Strength(s): 11.25MG/VIAL [RLD], 15MG/VIAL [RLD]
Manufacturer: ABBOTT ENDOCRINE
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.
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.
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✓
- 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
- September 2, 2013✓
- 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
- May 20, 2014✓
- 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✓
- 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
- September 2, 2013✓
- 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, 2013
- December 13, 2016✓
- December 13, 2016
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".
See also...
- Lupron Depot-PED Kit Consumer Information (Wolters Kluwer)
- Lupron Depot-Ped Consumer Information (Cerner Multum)
- Lupron Depot-Ped 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)
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