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Dapsone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dapsone?

Dapsone is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Alvogen, Jacobus, Allergan Inc, North Creek Pharms, Nostrum Labs Inc, and Allergan, and is included in eight NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-five patent family members in twenty-three countries.

There are seven drug master file entries for dapsone. Nine suppliers are listed for this compound.

Summary for Generic Name: dapsone

Tradenames:2
Patents:6
Applicants:7
NDAs:8
Drug Master File Entries: see list7
Suppliers / Packagers: see list9
Bulk Api Vendors: see list84
Clinical Trials: see list31
Patent Applications: see list6,684
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dapsone at DailyMed

Pharmacology for Ingredient: dapsone

Ingredient-typeSulfones
Drug ClassSulfone
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 2005RXYesYes6,620,435► SubscribeY ► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 2005RXYesYes5,863,560► SubscribeY ► Subscribe
Alvogen
DAPSONE
dapsone
TABLET;ORAL205429-002Jan 7, 2016RXNoNo► Subscribe► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 2005RXYesYes6,060,085► Subscribe ► Subscribe
Alvogen
DAPSONE
dapsone
TABLET;ORAL205429-001Jan 7, 2016RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: dapsone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 20055,863,560► Subscribe
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 20166,620,435► Subscribe
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 20165,863,560► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 20056,620,435► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 20056,060,085► Subscribe
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International Patent Family for Ingredient: dapsone

Country Document Number Estimated Expiration
Germany69727398► Subscribe
Japan2006096774► Subscribe
China105246457► Subscribe
South Africa200407439► Subscribe
New Zealand535363► 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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