Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

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PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - Generic Drug Details

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What are the generic drug sources for phentermine hydrochloride; topiramate and what is the scope of freedom to operate?

Phentermine hydrochloride; topiramate is the generic ingredient in one branded drug marketed by Vivus and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride; topiramate has sixty-four patent family members in nineteen countries.

There are seventeen drug master file entries for phentermine hydrochloride; topiramate. One supplier is listed for this compound.

Summary for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado- Nutrition Obesity Research CenterPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
Jaime Moore, MD MPHPhase 2

See all PHENTERMINE HYDROCHLORIDE; TOPIRAMATE clinical trials

Recent Litigation for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
VIVUS, INC. v. TEVA PHARMACEUTICALS USA, INC.2015-04-15
VIVUS, INC. v. ACTAVIS LABORATORIES FL, INC.2014-06-12

See all PHENTERMINE HYDROCHLORIDE; TOPIRAMATE litigation

Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Tradename Dosage Ingredient NDA Submissiondate
QSYMIA CAPSULE, EXTENDED RELEASE;ORAL phentermine hydrochloride; topiramate 022580 2013-07-18

US Patents and Regulatory Information for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012   Start Trial   Start Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Colorcon

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