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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Chinese Patent Office
Colorcon
Dow
Fish and Richardson
McKinsey
Covington
Moodys
Express Scripts

Generated: October 18, 2017

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Dapsone - Generic Drug Details

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What are the generic sources for dapsone and what is the scope of dapsone freedom to operate?

Dapsone
is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Alvogen, Jacobus, Allergan Inc, Virtus Pharms, Actavis Llc, Nostrum Labs Inc, and Allergan, and is included in nine NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapsone has fifty patent family members in twenty-three countries.

There are eight drug master file entries for dapsone. Ten suppliers are listed for this compound.

Summary for Generic Name: dapsone

US Patents:5
Tradenames:2
Applicants:8
NDAs:9
Drug Master File Entries: see list8
Suppliers / Packagers: see list10
Bulk Api Vendors: see list84
Clinical Trials: see list78
Patent Applications: see list7,227
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Actavis Llc
DAPSONE
dapsone
TABLET;ORAL204380-001Mar 23, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Nostrum Labs Inc
DAPSONE
dapsone
TABLET;ORAL203887-001May 6, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Par Pharm Inc
DAPSONE
dapsone
TABLET;ORAL206505-002Dec 1, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Virtus Pharms
DAPSONE
dapsone
TABLET;ORAL204074-002May 10, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Jacobus
DAPSONE
dapsone
TABLET;ORAL086842-001Approved Prior to Jan 1, 1982ABRXNoYes► Subscribe► 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, 2005► Subscribe► Subscribe
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 2016► Subscribe► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 2005► Subscribe► Subscribe
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 2016► Subscribe► Subscribe
Allergan Inc
ACZONE
dapsone
GEL;TOPICAL207154-001Feb 24, 2016► Subscribe► Subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 2005► Subscribe► Subscribe
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International Patent Family for Ingredient: dapsone

Country Document Number Estimated Expiration
Hong Kong1214516► Subscribe
Iceland7419► Subscribe
World Intellectual Property Organization (WIPO)2014081674► Subscribe
Hong Kong1072010► Subscribe
Canada2890224► Subscribe
Japan2006096774► Subscribe
Australia2002306767► Subscribe
Japan2016500072► Subscribe
Japan4276298► Subscribe
South Africa200407439► 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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
Cantor Fitzgerald
US Army
US Department of Justice
Accenture
Fish and Richardson
AstraZeneca
Dow
Medtronic

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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