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Serving 500+ biopharmaceutical companies globally:

Argus Health
QuintilesIMS
US Department of Justice
McKinsey
Colorcon
Boehringer Ingelheim
Healthtrust
Accenture
Chubb
Farmers Insurance

Generated: September 24, 2017

DrugPatentWatch Database Preview

Gabapentin enacarbil - Generic Drug Details

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What are the generic drug sources for gabapentin enacarbil and what is the scope of gabapentin enacarbil patent protection?

Gabapentin enacarbil
is the generic ingredient in one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gabapentin enacarbil has one hundred and forty-two patent family members in twenty-five countries.

There are twenty-six drug master file entries for gabapentin enacarbil. Two suppliers are listed for this compound.

Summary for Generic Name: gabapentin enacarbil

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list26
Suppliers / Packagers: see list2
Bulk Api Vendors: see list24
Clinical Trials: see list322
Patent Applications: see list106
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:gabapentin enacarbil at DailyMed

Pharmacology for Ingredient: gabapentin enacarbil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-001Apr 6, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-001Apr 6, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-001Apr 6, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-001Apr 6, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-001Apr 6, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Arbor Pharms Llc
HORIZANT
gabapentin enacarbil
TABLET, EXTENDED RELEASE;ORAL022399-002Dec 13, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: gabapentin enacarbil

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
8,906,412GABA analog prodrug sustained release oral dosage forms► Subscribe
6,833,140 Orally administered dosage forms of GABA analog prodrugs having reduced toxicity► Subscribe
7,423,169Methods for synthesis of acyloxyalkyl derivatives of GABA analogs► Subscribe
7,232,924Methods for synthesis of acyloxyalkyl derivatives of GABA analogs► Subscribe
7,186,855Prodrugs of GABA analogs, compositions and uses thereof► Subscribe
9,150,503Crystalline form of .gamma.-aminobutyric acid analog► Subscribe
8,367,722Methods of using prodrugs of pregabalin► Subscribe
9,238,616Prodrugs of gaba analogs, compositions and uses thereof► Subscribe
6,972,341 Prodrugs of GABA analogs, compositions and uses thereof► Subscribe
8,168,623Prodrugs of GABA analogs, compositions and uses thereof► 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: gabapentin enacarbil

Country Document Number Estimated Expiration
Israel174282► Subscribe
Japan5107576► Subscribe
World Intellectual Property Organization (WIPO)02100392► Subscribe
MexicoPA03011565► Subscribe
Denmark1404324► Subscribe
Norway20062112► Subscribe
Russian Federation2440112► Subscribe
South Africa200309678► Subscribe
Israel159300► Subscribe
Hong Kong1090850► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Julphar
Mallinckrodt
Accenture
Chubb
Federal Trade Commission
Cantor Fitzgerald
Cerilliant
Daiichi Sankyo
Argus Health
McKinsey

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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ISSN: 2162-2639

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