METHYLPHENIDATE Drug Patent Profile
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When do Methylphenidate patents expire, and when can generic versions of Methylphenidate launch?
Methylphenidate is a drug marketed by Mylan Tech Viatris, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Patrin, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc. and is included in seventy-one NDAs.
The generic ingredient in METHYLPHENIDATE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methylphenidate
A generic version of METHYLPHENIDATE was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
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Questions you can ask:
- What is the 5 year forecast for METHYLPHENIDATE?
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- What is Average Wholesale Price for METHYLPHENIDATE?
Summary for METHYLPHENIDATE
US Patents: | 0 |
Applicants: | 43 |
NDAs: | 71 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 25 |
Clinical Trials: | 418 |
Patent Applications: | 5,355 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for METHYLPHENIDATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METHYLPHENIDATE |
What excipients (inactive ingredients) are in METHYLPHENIDATE? | METHYLPHENIDATE excipients list |
DailyMed Link: | METHYLPHENIDATE at DailyMed |
![METHYLPHENIDATE drug patent expirations Drug patent expirations by year for METHYLPHENIDATE](/p/graph/s/t/METHYLPHENIDATE-patent-expirations.png)
![Drug Prices for METHYLPHENIDATE](/p/graph/drug-price/METHYLPHENIDATE.png)
See drug prices for METHYLPHENIDATE
![Drug Sales Revenue Trends for METHYLPHENIDATE](/p/graph/drug-sales-revenues/METHYLPHENIDATE.png)
Recent Clinical Trials for METHYLPHENIDATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Florida | Early Phase 1 |
Medical University of Lodz | Phase 2 |
Medical University of Gdansk | Phase 2 |
Pharmacology for METHYLPHENIDATE
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for METHYLPHENIDATE
Anatomical Therapeutic Chemical (ATC) Classes for METHYLPHENIDATE
Paragraph IV (Patent) Challenges for METHYLPHENIDATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
COTEMPLA XR-ODT | Extended-release Orally Disintegrating Tablets | methylphenidate | 8.6 mg, 17.3 mg and 25.9 mg | 205489 | 1 | 2017-09-01 |
DAYTRANA | Transdermal System | methylphenidate | 10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs | 021514 | 1 | 2011-04-13 |