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Phentermine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for phentermine hydrochloride?

Phentermine hydrochloride is the generic ingredient in eleven branded drugs marketed by Vitarine, Able, Usl Pharma, Sandoz Inc, Tg United Labs, Sandoz, Ken Lifescience, Mast Mm, Abc Holding, Teva, Invagen Pharms, Aurolife Pharma Llc, Lannett, Sun Pharm Inds, Camall, Mikah Pharma, Mikah Pharma Llc, Ivax Pharms, Solvay, Watson Labs, Polygen Pharms, Ferndale Labs, Duramed Pharms Barr, Elite Labs, Ingenus Pharms Nj, Glaxosmithkline, Lannett Holdings Inc, Shire Richwood, Barr, Kvk Tech, Actavis Elizabeth, Prinston Inc, Tg United Inc, Citius Pharms, Sun Pharm Inds Inc, Avanthi Inc, and Vivus, and is included in ninety-eight NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride has twelve patent family members in ten countries.

There are seventeen drug master file entries for phentermine hydrochloride. Forty-seven suppliers are listed for this compound.

Summary for Generic Name: phentermine hydrochloride

Drug Master File Entries: see list17
Suppliers / Packagers: see list47
Bulk Api Vendors: see list24
Clinical Trials: see list1,001
Patent Applications: see list1,035
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:phentermine hydrochloride at DailyMed

Pharmacology for Ingredient: phentermine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tg United Labs
phentermine hydrochloride
CAPSULE;ORAL088611-001Jun 4, 1984DISCNNoNo► Subscribe► Subscribe
phentermine hydrochloride
CAPSULE;ORAL087022-001Feb 3, 1983RXNoNo► Subscribe► Subscribe
phentermine hydrochloride
CAPSULE;ORAL088614-001Apr 9, 1984DISCNNoNo► Subscribe► Subscribe
phentermine hydrochloride; topiramate
CAPSULE, EXTENDED RELEASE;ORAL022580-004Jul 17, 2012RXYesYes7,674,776► SubscribeY ► Subscribe
Kvk Tech
phentermine hydrochloride
TABLET;ORAL040876-001Mar 31, 2008RXNoNo► Subscribe► Subscribe
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International Patent Family for Ingredient: phentermine hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9904758► Subscribe
Australia8977698► Subscribe
Canada2298487► Subscribe
Japan4947833► Subscribe
European Patent Office2278590► 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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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.