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Last Updated: November 18, 2019

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Details for Patent: 6,958,326

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Summary for Patent: 6,958,326
Title: Cyclodextrin-drospirenone inclusion complexes
Abstract:Pharmaceutical compositions comprising low doses of sensitive complexes between an estrogen and a cyclodextrin are provided with improved stability. In specific embodiments the composition comprises a complex between ethinyl estradiol and .beta.-cyclodextrin in a granulate preparation and in yet another embodiment the composition comprises a limited amount of polyvinylpyrrolidone since this excipient was found to degrade ethinyl estradiol. Furthermore, a method for improving the stability of an estrogen in a composition and for manufacturing such a stable composition is provided. Essentially, the granulate preparation are manufactured under careful control of the relative humidity.
Inventor(s): Backensfeld; Thomas (Berlin, DE), Heil; Wolfgang (Berlin, DE), Lipp; Ralph (Berlin, DE)
Assignee: Schering AG (Berlin, DE)
Application Number:10/022,845
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,958,326
Patent Claim Types:
see list of patent claims
Composition; Use; Formulation; Process;

Drugs Protected by US Patent 6,958,326

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 6,958,326

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
00610135Dec 20, 2000

International Family Members for US Patent 6,958,326

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 032205   Start Trial
Austria 311204   Start Trial
Australia 1941802   Start Trial
Australia 2002219418   Start Trial
Australia 2006225232   Start Trial
Bulgaria 108002   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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