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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Chubb
McKesson
Colorcon
Fuji
Deloitte
Dow
Johnson and Johnson
Accenture
Novartis

Generated: January 20, 2018

DrugPatentWatch Database Preview

Dexmethylphenidate hydrochloride - Generic Drug Details

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What are the generic sources for dexmethylphenidate hydrochloride and what is the scope of dexmethylphenidate hydrochloride freedom to operate?

Dexmethylphenidate hydrochloride
is the generic ingredient in three branded drugs marketed by Impax Labs Inc, Intellipharmaceutics, Mylan Pharms Inc, Par Pharm Inc, Teva Pharms Usa, Novartis, Abhai Inc, Lannett, Novel Labs Inc, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in sixteen NDAs. There are two patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmethylphenidate hydrochloride has one hundred and forty-two patent family members in thirty-three countries.

There are five drug master file entries for dexmethylphenidate hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dexmethylphenidate hydrochloride
Pharmacology for dexmethylphenidate hydrochloride
Medical Subject Heading (MeSH) Categories for dexmethylphenidate hydrochloride
Tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe5MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Subscribe➤ Subscribe40MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Subscribe➤ Subscribe35MGCAPSULE, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for dexmethylphenidate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Abhai Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 206931-002 Dec 4, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204266-001 Aug 25, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908-002 Nov 19, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 077107-002 Jan 29, 2007 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202842-006 Nov 30, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Abhai Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 206931-001 Dec 4, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202731-001 Jul 5, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Intellipharmaceutics DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078992-003 Nov 18, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for dexmethylphenidate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-002 Nov 13, 2001 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 ➤ Subscribe ➤ Subscribe
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for dexmethylphenidate 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
6,793,936 Multiparticulate modified release composition ➤ Subscribe
6,902,742 Multiparticulate modified release composition ➤ Subscribe
8,119,163 Nanoparticulate and controlled release compositions comprising cefditoren ➤ Subscribe
7,580,712 Wireless high-speed data network planning tool ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for dexmethylphenidate hydrochloride

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Baxter
Daiichi Sankyo
Teva
Julphar
McKinsey
Dow
Argus Health

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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