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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Daiichi Sankyo
Fish and Richardson
McKinsey
Accenture
Chinese Patent Office
Chubb
Baxter
Cerilliant
Colorcon

Generated: December 18, 2017

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Aminolevulinic acid hydrochloride - Generic Drug Details

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What are the generic drug sources for aminolevulinic acid hydrochloride and what is the scope of aminolevulinic acid hydrochloride patent protection?

Aminolevulinic acid hydrochloride
is the generic ingredient in three branded drugs marketed by Nxdc, Biofrontera, and Dusa, and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aminolevulinic acid hydrochloride has sixty-two patent family members in twenty-two countries.

There are six drug master file entries for aminolevulinic acid hydrochloride. Two suppliers are listed for this compound.

Pharmacology for aminolevulinic acid hydrochloride

Ingredient-typePorphyrinogens
Drug ClassPorphyrin Precursor

Medical Subject Heading (MeSH) Categories for aminolevulinic acid hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
BiofronteraAMELUZaminolevulinic acid hydrochlorideGEL;TOPICAL208081-001May 10, 2016RXYesYes► Subscribe► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999RXYesYes► Subscribe► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999RXYesYes► Subscribe► Subscribe► Subscribe
BiofronteraAMELUZaminolevulinic acid hydrochlorideGEL;TOPICAL208081-001May 10, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999RXYesYes► Subscribe► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999RXYesYes► Subscribe► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999RXYesYes► Subscribe► Subscribe► Subscribe
NxdcGLEOLANaminolevulinic acid hydrochlorideFOR SOLUTION;ORAL208630-001Jun 6, 2017RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: aminolevulinic acid hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
DusaLEVULANaminolevulinic acid hydrochlorideSOLUTION;TOPICAL020965-001Dec 3, 1999► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: aminolevulinic acid hydrochloride

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
6,223,071 Illuminator for photodynamic therapy and diagnosis which produces substantially uniform intensity visible light► Subscribe
9,723,991Illuminator for photodynamic therapy► Subscribe
8,030,836Illuminator for photodynamic therapy► Subscribe
7,190,109Illuminator for photodynamic therapy► 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 Ingredient: aminolevulinic acid hydrochloride

Country Document Number Estimated Expiration
Austria285817► Subscribe
New Zealand511351► Subscribe
New Zealand504366► Subscribe
Portugal1027093► Subscribe
European Patent Office1566200► Subscribe
Germany59908665► Subscribe
Spain2226188► Subscribe
China1308553► Subscribe
Germany69940488► Subscribe
Hungary0101340► 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:

Novartis
Julphar
Queensland Health
Accenture
Colorcon
Medtronic
McKesson
US Department of Justice
UBS
Baxter

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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