➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Express Scripts
McKesson
Baxter
Mallinckrodt

Last Updated: May 11, 2021

DrugPatentWatch Database Preview

DEXMETHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for dexmethylphenidate hydrochloride and what is the scope of patent protection?

Dexmethylphenidate hydrochloride is the generic ingredient in three branded drugs marketed by Adare Pharms Inc, Granules Pharms, Impax Labs Inc, Intellipharmaceutics, Mylan, Par Pharm Inc, Teva Pharms Usa, Novartis, Abhai Inc, Alkem Labs Ltd, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, Tris Pharma Inc, and Uspharma, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for dexmethylphenidate hydrochloride. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for DEXMETHYLPHENIDATE HYDROCHLORIDE

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

SponsorPhase
Cingulate TherapeuticsPhase 1
Cingulate TherapeuticsPhase 1/Phase 2
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)N/A

See all DEXMETHYLPHENIDATE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $1040MGCAPSULE, EXTENDED RELEASE;ORAL
  Get Started for $10  Get Started for $1035MGCAPSULE, EXTENDED RELEASE;ORAL
  Get Started for $10  Get Started for $1025MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DEXMETHYLPHENIDATE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DEXMETHYLPHENIDATE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DEXMETHYLPHENIDATE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2011-09-30
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2011-09-29
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2010-12-20
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2010-12-15
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2007-05-14
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2007-03-30
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 2004-07-27
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 2004-05-27

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
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202731-004 Jul 5, 2017 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Mylan DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204266-007 Aug 25, 2015 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908-003 Nov 19, 2013 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Adare Pharms Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210279-003 Oct 9, 2018 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Lannett Co Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 209468-001 Sep 25, 2017 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>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 DEXMETHYLPHENIDATE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005   Get Started for $10   Get Started for $10
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010   Get Started for $10   Get Started for $10
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011   Get Started for $10   Get Started for $10
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011   Get Started for $10   Get Started for $10
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
McKinsey
Johnson and Johnson
AstraZeneca
Boehringer Ingelheim

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 verification 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.