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Serving leading biopharmaceutical companies globally:

Merck
Teva
Accenture
Cipla
Fuji
Covington
Julphar
Dow
McKesson
Argus Health

Generated: December 18, 2017

DrugPatentWatch Database Preview

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 Allergan, Allergan Inc, Taro, Actavis Llc, Alvogen, Jacobus, Nostrum Labs Inc, Novitium Pharma, and Virtus Pharms, and is included in ten 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. Thirteen suppliers are listed for this compound.

Pharmacology for dapsone

Ingredient-typeSulfones
Drug ClassSulfone

Medical Subject Heading (MeSH) Categories for dapsone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nostrum Labs IncDAPSONEdapsoneTABLET;ORAL203887-002May 6, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Novitium PharmaDAPSONEdapsoneTABLET;ORAL206505-002Dec 1, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
TaroDAPSONEdapsoneGEL;TOPICAL209506-001Oct 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
AllerganACZONEdapsoneGEL;TOPICAL021794-001Jul 7, 2005ABRXYesYes► Subscribe► Subscribe► Subscribe
Allergan IncACZONEdapsoneGEL;TOPICAL207154-001Feb 24, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
JacobusDAPSONEdapsoneTABLET;ORAL086841-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
JacobusDAPSONEdapsoneTABLET;ORAL086842-001Approved Prior to Jan 1, 1982ABRXNoYes► Subscribe► Subscribe► Subscribe
Actavis LlcDAPSONEdapsoneTABLET;ORAL204380-001Mar 23, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis LlcDAPSONEdapsoneTABLET;ORAL204380-002Mar 23, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Novitium PharmaDAPSONEdapsoneTABLET;ORAL206505-001Dec 1, 2016ABRXNoNo► 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 IncACZONEdapsoneGEL;TOPICAL207154-001Feb 24, 2016► Subscribe► Subscribe
AllerganACZONEdapsoneGEL;TOPICAL021794-001Jul 7, 2005► Subscribe► Subscribe
Allergan IncACZONEdapsoneGEL;TOPICAL207154-001Feb 24, 2016► Subscribe► Subscribe
AllerganACZONEdapsoneGEL;TOPICAL021794-001Jul 7, 2005► Subscribe► Subscribe
AllerganACZONEdapsoneGEL;TOPICAL021794-001Jul 7, 2005► Subscribe► Subscribe
Allergan IncACZONEdapsoneGEL;TOPICAL207154-001Feb 24, 2016► Subscribe► Subscribe
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International Patent Family for Ingredient: dapsone

Country Document Number Estimated Expiration
MexicoPA02006593► Subscribe
Japan2005524651► Subscribe
World Intellectual Property Organization (WIPO)2014081674► Subscribe
China105246457► Subscribe
European Patent Office2922528► Subscribe
Slovenia1485059► Subscribe
Spain2280629► Subscribe
South Africa200407439► Subscribe
Iceland7419► Subscribe
South Korea20150085069► 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:

AstraZeneca
Moodys
Julphar
Covington
Healthtrust
Chubb
Teva
Novartis
UBS
Argus Health

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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