METHYLPHENIDATE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Methylphenidate Hydrochloride, and what generic alternatives are available?
Methylphenidate Hydrochloride is a drug marketed by 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, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, 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 sixty-nine NDAs.
The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methylphenidate Hydrochloride
A generic version of METHYLPHENIDATE HYDROCHLORIDE was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
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Summary for METHYLPHENIDATE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 42 |
| NDAs: | 69 |
| Finished Product Suppliers / Packagers: | 35 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 418 |
| Patent Applications: | 3,514 |
| Drug Prices: | Drug price information for METHYLPHENIDATE HYDROCHLORIDE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METHYLPHENIDATE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in METHYLPHENIDATE HYDROCHLORIDE? | METHYLPHENIDATE HYDROCHLORIDE excipients list |
| DailyMed Link: | METHYLPHENIDATE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for METHYLPHENIDATE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Florida | Early Phase 1 |
| Institute of Medical Sciences of the University of Opole | Phase 2 |
| Medical University of Silesia | Phase 2 |
Pharmacology for METHYLPHENIDATE HYDROCHLORIDE
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Anatomical Therapeutic Chemical (ATC) Classes for METHYLPHENIDATE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for METHYLPHENIDATE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| QUILLICHEW ER | Extended-release Chewable Tablets | methylphenidate hydrochloride | 20 mg, 30 mg and 40 mg | 207960 | 1 | 2016-04-25 |
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 30 mg | 205831 | 1 | 2016-03-28 |
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 15 mg, 20 mg, 40 mg and 50 mg | 205831 | 1 | 2015-12-28 |
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 10 mg | 205831 | 1 | 2015-12-24 |
| APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 60 mg | 205831 | 1 | 2015-12-23 |
| QUILLIVANT XR | Extended-release Oral Suspension | methylphenidate hydrochloride | 5 mg/mL | 202100 | 2013-08-02 | |
| METHYLIN | Oral Solution | methylphenidate hydrochloride | 5 mg/5 mL 10 mg/5 mL | 021419 | 1 | 2010-04-13 |
| RITALIN LA | Extended-release Capsules | methylphenidate hydrochloride | 10 mg | 021284 | 1 | 2007-05-21 |
| METADATE CD | Extended-release Capsules | methylphenidate hydrochloride | 40 mg | 021259 | 1 | 2007-03-15 |
| RITALIN LA | Extended-release Capsules | methylphenidate hydrochloride | 20 mg, 30 mg and 40 mg | 021284 | 2006-08-21 | |
| CONCERTA | Extended-release Tablets | methylphenidate hydrochloride | 18 mg*, 27 mg, 36 mg and 54 mg | 021121 | 2005-07-19 | |
| METADATE CD | Extended-release Capsules | methylphenidate hydrochloride | 10 mg, 20 mg and 30 mg | 021259 | 1 | 2005-05-13 |
US Patents and Regulatory Information for METHYLPHENIDATE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, CHEWABLE;ORAL | 205756-003 | Nov 7, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ani Pharms | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208607-002 | Jul 14, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abhai Llc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | SOLUTION;ORAL | 207485-001 | Nov 18, 2016 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Specgx Llc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 203583-005 | Sep 29, 2015 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
