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Dexmethylphenidate hydrochloride - Generic Drug Details
What are the generic drug sources for dexmethylphenidate hydrochloride and what is the scope of freedom to operate?
Dexmethylphenidate hydrochloride
is the generic ingredient in three branded drugs marketed by Adare Pharms Inc, 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, and Tris Pharma Inc, and is included in twenty 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 six drug master file entries for dexmethylphenidate hydrochloride. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dexmethylphenidate hydrochloride
| International Patents: | 142 |
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 16 |
| NDAs: | 20 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 15 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 12 |
| Patent Applications: | 6 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dexmethylphenidate hydrochloride |
| DailyMed Link: | dexmethylphenidate hydrochloride at DailyMed |
Recent Clinical Trials for dexmethylphenidate hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cingulate Therapeutics | Phase 1/Phase 2 |
| Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) | N/A |
| University of East Anglia | N/A |
Recent Litigation for dexmethylphenidate hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Recro Gainesville LLC v. Actavis Laboratories FL, Inc. | 2017-10-30 |
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
| Recro Gainesville LLC v. Alvogen Malta Operations Ltd. | 2014-11-03 |
Generic filers with tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 10MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Start Trial | Start Trial | 5MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Start Trial | Start Trial | 40MG | CAPSULE, 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
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for dexmethylphenidate hydrochloride
Synonyms for dexmethylphenidate hydrochloride
| (+/-)-threo-Methylphenidate hydrochloride |
| (|AR,2R)-|A-Phenyl-2-piperidineacetic Acid Methyl Ester Hydrochloride |
| (2R,2 inverted exclamation mark R)-(+)-threo-Methyl |A-Phenyl-|A-(2-piperidyl)acetate Hydrochloride |
| 1678OK0E08 |
| 19262-68-1 |
| 2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (alphaR,2R)- |
| 2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (R-(R*,R*))- |
| 2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (R*,R*)- (+-)- |
| 23655-65-4 |
| 35652-13-2 |
| 56502-30-8 |
| AC1L4BP0 |
| AKOS027321667 |
| Biphentin |
| CHEMBL904 |
| d-Ritalin Hydrochloride |
| d-threo methylphenidate hydrochloride |
| D-threo-Methylphenidate hydrochloride |
| D03721 |
| dex-methylphenidate hydrochloride |
| Dexmethylphenidate HCl |
| Dexmethylphenidate hydrochloride (USAN) |
| Dexmethylphenidate hydrochloride [USAN] |
| dl-threo-Methylphenidate HCl |
| dl-threo-Methylphenidate Hydrochloride |
| Equasym IR |
| Equasym XL |
| Focalin |
| Focalin (TN) |
| Focalin XR |
| JUMYIBMBTDDLNG-OJERSXHUSA-N |
| LS-114148 |
| LS-194106 |
| Metadate MR |
| methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate hydrochloride |
| methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate;hydrochloride |
| Methyl (2R)-phenyl((2R)-piperidin-2-yl)acetate hydrochloride |
| Methylphenidate Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| MethyPatch |
| NWP-06 |
| Ritalin QD |
| SB13180 |
| UNII-1678OK0E08 |
| UNII-4B3SC438HI component JUMYIBMBTDDLNG-OJERSXHUSA-N |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204266-002 | Aug 25, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Intellipharmaceutics | DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078992-004 | Nov 18, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Alkem Labs Ltd | DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | TABLET;ORAL | 212631-003 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Pharms Usa | DEXMETHYLPHENIDATE HYDROCHLORIDE | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078908-004 | May 19, 2014 | AB | RX | No | 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 dexmethylphenidate hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-008 | Apr 21, 2011 | Start Trial | Start Trial |
| Novartis | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | Start Trial | Start Trial |
| Novartis | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-001 | Nov 13, 2001 | Start Trial | Start Trial |
| Novartis | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-008 | Apr 21, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dexmethylphenidate hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 200701195 | Start Trial |
| Hong Kong | 1050487 | Start Trial |
| Norway | 20090158 | Start Trial |
| Canada | 2611506 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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ISSN: 2162-2639
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Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.