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Details for Patent: 5,993,856

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Patent 5,993,856 protects BUTOCONAZOLE NITRATE and CLINDESSE and is included in two NDAs. There has been one Paragraph IV challenge on Clindesse.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 5,993,856

Title: Pharmaceutical preparations and methods for their administration
Abstract:Formulations which have been developed for topical or local delivery intrapelvically, intraperitoneally or directly on reproductive organs of interest administration to a region such as the female reproductive system, provide for increased comfort, increased bioavailability, rapid and relatively high blood levels in the regions to be treated in the substantial absence of systemic levels of drug which might cause side effects. These formulations consist of drug micro or nanoparticles, which may be formed of drug alone or in combination with an excipient or polymeric carrier. The excipient or polymer may be used to manipulate release rates and to increase adhesion to the affected region. The particulate formulation can be applied as a dried powder, a liquid suspension or dispersion, or as a topical ointment, creme, lotion, foam or suppository.
Inventor(s): Ragavan; Vanaja V. (Wynnewood, PA), DiPiano; Gerrianne M. (Malvern, PA)
Assignee: FemmePharma (Wayne, PA)
Application Number:08/971,346
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Use; Composition; Delivery;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 40th percentile
Forward Citations: 13th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Perrigo Pharma Intl
BUTOCONAZOLE NITRATE
butoconazole nitrate
CREAM;VAGINAL019881-001Feb 7, 1997DISCNNo5,993,856► subscribeY METHOD OF TREATING A VAGINAL FUNGAL INFECTION IN A FEMALE HUMAN
Perrigo Pharma Intl
CLINDESSE
clindamycin phosphate
CREAM;VAGINAL050793-001Nov 30, 2004RXYes5,993,856► subscribeY METHOD OF TREATING BACTERIAL VAGINOSIS
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Non-Orange Book Patents for Patent: 5,993,856

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,652,874 Pharmaceutical preparations and methods for their regional administration► subscribe
6,416,778 Pharmaceutical preparations and methods for their regional administration► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 5,993,856

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria321532► subscribe
Australia5922798► subscribe
Australia743157► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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