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Generated: June 29, 2017
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, North Creek Pharms, Actavis Llc, Nostrum Labs Inc, and Allergan, and is included in nine NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 6 |
| Applicants: | 8 |
| NDAs: | 9 |
| Drug Master File Entries: see list | 7 |
| Suppliers / Packagers: see list | 10 |
| Bulk Api Vendors: see list | 84 |
| Clinical Trials: see list | 76 |
| Patent Applications: see list | 6,732 |
| Therapeutic Class: | Antimycobacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | dapsone at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | RX | Yes | Yes | 5,863,560 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | RX | Yes | Yes | 6,060,085 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | RX | Yes | Yes | 6,620,435 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
North Creek Pharms | DAPSONE | dapsone | TABLET;ORAL | 204074-001 | May 10, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Allergan Inc | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | RX | Yes | Yes | 6,060,085 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | 6,060,085 | ► Subscribe | ||||||||||||||||||||||
Allergan Inc | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | 5,863,560 | ► Subscribe | ||||||||||||||||||||||
Allergan Inc | ACZONE | dapsone | GEL;TOPICAL | 207154-001 | Feb 24, 2016 | 6,620,435 | ► Subscribe | ||||||||||||||||||||||
Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | 5,863,560 | ► Subscribe | ||||||||||||||||||||||
Allergan | ACZONE | dapsone | GEL;TOPICAL | 021794-001 | Jul 7, 2005 | 6,620,435 | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Iceland | 7419 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2280629 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 0957900 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2015123207 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2013348247 | ► 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 500+ biopharmaceutical companies globally:
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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