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Last Updated: January 21, 2022

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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 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 Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Boehringer Ingelheim

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