Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2005-02-15
2005-02-15
Badio, Barbara P. (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
active
06855703
ABSTRACT:
A composition of matter is provided having a mixture of active estrogenic compounds. The mixture is present in chemically pure form. The mixture includes salts of conjugated estrone, conjugated equilin, conjugated Δ8,9-dehydroestrone, conjugated 17α-estradiol, conjugated 17α-dihydroequilin, conjugated 17β-dihydroequilin, conjugated 17β-estradiol, conjugated equilenin, conjugated 17α-dihydroequilenin, and conjugated 17β-dihydroequilenin. The mixture also contains the same essential estrogenic compounds present in naturally derived equine conjugated estrogens. Drug products including the composition of matter are also provided, as are methods of using these drug products to treat mammals in need of treatment. Methods of analyzing mixtures containing conjugated estrogens are also provided.
REFERENCES:
patent: 3230142 (1966-01-01), Spero
patent: 3487152 (1969-12-01), Carstensen et al.
patent: 3502772 (1970-03-01), Ijzerman
patent: 3568828 (1971-03-01), Lerner
patent: 3591688 (1971-07-01), Jones et al.
patent: 3639600 (1972-02-01), Hendrix
patent: 3733407 (1973-05-01), Segre
patent: 3795734 (1974-03-01), Rochefort
patent: 3813418 (1974-05-01), Hofmeister et al.
patent: 3836651 (1974-09-01), Rudel et al.
patent: 3932635 (1976-01-01), Segre
patent: 3939264 (1976-02-01), Lachnit-Fixson
patent: 3942641 (1976-03-01), Segre
patent: 3957982 (1976-05-01), Lachnit-Fixson et al.
patent: 3969502 (1976-07-01), Lachnit-Fixson
patent: 4027019 (1977-05-01), Shroff
patent: 4066757 (1978-01-01), Pasquale
patent: 4071623 (1978-01-01), van der Vies
patent: 4145416 (1979-03-01), Lachnit-Fixson et al.
patent: 4147783 (1979-04-01), van der Vies
patent: 4154820 (1979-05-01), Simoons
patent: 4210644 (1980-07-01), Ewing et al.
patent: 4259325 (1981-03-01), Prezewowsky et al.
patent: 4291028 (1981-09-01), Vorys
patent: 4292315 (1981-09-01), Vorys
patent: 4315925 (1982-02-01), Hussain et al.
patent: 4327725 (1982-05-01), Cortese et al.
patent: 4378356 (1983-03-01), De Jager
patent: 4383993 (1983-05-01), Hussain et al.
patent: 4390531 (1983-06-01), Edgren
patent: 4425339 (1984-01-01), Pitchford
patent: 4512986 (1985-04-01), Reel et al.
patent: 4530839 (1985-07-01), Pasquale
patent: 4544554 (1985-10-01), Pasquale
patent: 4616006 (1986-10-01), Pasquale
patent: 4621079 (1986-11-01), Lachnit-Fixson et al.
patent: 4628051 (1986-12-01), Pasquale
patent: 4738957 (1988-04-01), Laurent et al.
patent: 4756907 (1988-07-01), Beck et al.
patent: 4762717 (1988-08-01), Crowley, Jr.
patent: 4764378 (1988-08-01), Keith et al.
patent: 4783337 (1988-11-01), Wong et al.
patent: 4816257 (1989-03-01), Buster et al.
patent: 4816258 (1989-03-01), Nedberge et al.
patent: 4826831 (1989-05-01), Plunkett et al.
patent: 4855305 (1989-08-01), Cohen
patent: 4900734 (1990-02-01), Maxson et al.
patent: 4914089 (1990-04-01), Tax
patent: 4921843 (1990-05-01), Pasquale
patent: 4962098 (1990-10-01), Boissonneault
patent: 4977147 (1990-12-01), Jungblut et al.
patent: 5006345 (1991-04-01), Lang
patent: 5010070 (1991-04-01), Boissonneault
patent: 5043331 (1991-08-01), Hirvonen et al.
patent: 5089482 (1992-02-01), Hermens et al.
patent: 5098714 (1992-03-01), Wright et al.
patent: 5108995 (1992-04-01), Casper
patent: 5130137 (1992-07-01), Crowley, Jr.
patent: 5183814 (1993-02-01), Dukes
patent: 5200197 (1993-04-01), Wright et al.
patent: 5208225 (1993-05-01), Boissonneault et al.
patent: 5210081 (1993-05-01), Raveendranath et al.
patent: 5262408 (1993-11-01), Bergink
patent: 5276022 (1994-01-01), Casper
patent: 5280023 (1994-01-01), Ehrlich et al.
patent: 5288717 (1994-02-01), Raveendranath et al.
patent: 5362720 (1994-11-01), Labrie
patent: 5382573 (1995-01-01), Casper
patent: 5418228 (1995-05-01), Bennink
patent: 5434146 (1995-07-01), Labrie et al.
patent: 5510342 (1996-04-01), Washburn et al.
patent: 5541172 (1996-07-01), Labrie
patent: 5545634 (1996-08-01), Labrie
patent: 5547948 (1996-08-01), Barcomb
patent: 5567695 (1996-10-01), Labrie
patent: 5629303 (1997-05-01), Labrie et al.
patent: 5654011 (1997-08-01), Jackson et al.
patent: 5753639 (1998-05-01), Labrie
patent: 5759576 (1998-06-01), Barcomb
patent: 5759577 (1998-06-01), Barcomb
patent: 5807586 (1998-09-01), Jackson et al.
patent: 5846960 (1998-12-01), Labrie
patent: 5861387 (1999-01-01), Labrie et al.
patent: 5861431 (1999-01-01), Hildebrand et al.
patent: 5908638 (1999-06-01), Huber et al.
patent: RE36247 (1999-07-01), Plunkett et al.
patent: 6040333 (2000-03-01), Jackson
patent: 2431694 (1976-03-01), None
patent: 2624025 (1976-12-01), None
patent: 3341638 (1983-11-01), None
patent: 0322020 (1989-06-01), None
patent: 1214712 (1970-12-01), None
patent: 1561244 (1980-02-01), None
patent: 2096462 (1982-10-01), None
patent: 25265 (1969-12-01), None
patent: WO9607416 (1996-03-01), None
patent: WO9704752 (1997-02-01), None
Townsend et al., J. of Chromatography, 450: 414-419, 1988.*
Memorandum, Center for Drug Evaluation and Research, May 5, 1997.*
PDR, 46: 2504-2518, 1992.*
Sakac, Marija N. et al., “Synthesis of New Steroidal N-butyl-N-methyl-undecanamide Derivatives,”Database Chemabs 'Online!, Database accession No. 133:335378 XP002171995, ZB. Matice SRP. Prir. Nauke 96: 5-9 (1999).
Sakac, Marijan N. et al., “Chemical Behavior of 3, 17.beta.-dipropionoxy-9.alpha.-hydroxyestra-1,3,5(10)-trien-6-one,”Database Chemabs 'Online!, Database accession No. 128:180573 XP002171996, J. Serb. Chem. Soc., 63(1): 21-24 (1998).
Wiese, Thomas et al., “Induction of the Estrogen Specific Mitogenic Response of MCF-7 Cells by Selected Analogues of Estradiol-17β: A 3D Study,”Journal of Medicinal Chemistry, 40(22): 3659-3669 (1997).
Yang et al., “The Hydroxylation and Amidation of Equilenin Acetate Catalyzed by Chloro[5,10,15,20-tetrakis(pentafluorophenyl)porphyrinato]managanese(III),”Chem. Commun., 7: 531-532 (2000).
Rzheznikov, V.M. et al., “Synthesis and Biological Activity of Estrone 8-iso- and and D-homoanalogs Oxidized for Rings B and C,”Database Chemabs 'Online!, Database accession No. 110:108353 XP002171997, Khim.-Farm. Zh. 22(12): 1462-1465 (1988).
Yang, Jerry et al., “Regioselective Oxidations of Equilenin Derivatives Catalyzed by a Phodium(III) Porphyrin Complex-Contrast with the Manganese(III) Porphyrin,”Tetrahedron Letters, 41(42): 8063-8067 (2000).
Andreolini, et al.,Estrogen Conjugates in Late-Pregnancy Fluids: Extraction and Group Separation by a Graphitized Carbon Black Cartridge and Quantification by High-Performance Liquid Chromatography, Anal. Chem. 59:1720-1725 (1987).
Fujino, et al.,3-(Difuoro-1,3,5-trianinyl)-1-(ethylthio)-2-n-propylbenz[f]isoindole as a Fluorescence Derivation Reagent for Estrogens in High-Performance Liquid Chromatography, Chem. Pharm. Bull., 37(7): 1939-1940 (1989).
Vest, Floyd B. & Karnes, H. Thomas,Luminescent Derivation of Estrogens for HPLC Detection(Abstract), Department of Pharmacy and Pharmaceutics, Medical College of Virginia, APQ 1198.
Takadate, et al.,A Convenient Derivatization with Anion Exchange Resin Catalysts for High-Performance Liquid Chromatographic Analysis. I. Derivatization of Estrogens with Dansyl Chloride, Chem. Pharm. Bull., 33(11): 5092-5095 (1985).
Novakovic, et al.,High-Performance Liquid Chromatographic Determination of Equine Estrogens with Ultraviolet Absorbance and Electrochemical Detection, Journal of Chromatography A, 678: 359-363 (1994).
Townsend, et al.,High-Performance Liquid Chromatographic Determination of Conjugated Estrogens in Tablets, Journal of Chromatography, 450: 414-419 (1988).
Ishida, et al.,Determination of Oestrogens in Pregnancy Urine by High-Performance Liquid Chromatography with Fluorescence Detection, Journal of Chromatography, 431: 249-257 (1988).
Conjugated Estrogens, The United States Pharmacopeia (USP), published by United States Pharmacopeial Convention, Inc., pp. 627-629 (2000).
Synthetic Generic Conjugated Estrogens: Timeline, May 5, 1997, <http://www.fda.gov/cder
ews/cetimeline.htm>.
FDA Statement on Generic Premarins, HHS News Press Release, P97-12, May 5, 1997, &#x
Hill Edward N.
Leonard Thomas W.
Sancilio Frederick D.
Schlipp Katherin M.
Shirazi Dean G.
Badio Barbara P.
Endeavor Pharmaceuticals
Myers Bigel Sibley & Sajovec P.A.
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