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Dexmethylphenidate hydrochloride - Generic Drug Details
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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, 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.
Summary for dexmethylphenidate hydrochloride
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 18 |
| NDAs: | 22 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 16 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 13 |
| Patent Applications: | 6 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dexmethylphenidate hydrochloride |
| What excipients (inactive ingredients) are in dexmethylphenidate hydrochloride? | dexmethylphenidate hydrochloride excipients list |
| 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 |
| Cingulate Therapeutics | Phase 1/Phase 2 |
| Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) | N/A |
Generic filers with tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 40MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Start Trial | Start Trial | 35MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Start Trial | Start Trial | 25MG | 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
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
Expired US Patents for dexmethylphenidate hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-002 | Nov 13, 2001 | Start Trial | Start Trial |
| Novartis | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-005 | Oct 23, 2009 | Start Trial | Start Trial |
| Novartis | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-003 | May 26, 2005 | Start Trial | Start Trial |
| Novartis | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-002 | Nov 13, 2001 | Start Trial | Start Trial |
| Novartis | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-005 | Oct 23, 2009 | Start Trial | Start Trial |
| Novartis | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-001 | Nov 13, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 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.
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