FOCALIN Drug Patent Profile
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Which patents cover Focalin, and when can generic versions of Focalin launch?
Focalin is a drug marketed by Sandoz and is included in two NDAs.
The generic ingredient in FOCALIN is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Focalin
A generic version of FOCALIN was approved as dexmethylphenidate hydrochloride by INTELLIPHARMACEUTICS on November 18th, 2013.
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Questions you can ask:
- What is the 5 year forecast for FOCALIN?
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Summary for FOCALIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 23 |
| Clinical Trials: | 12 |
| Patent Applications: | 36 |
| Drug Prices: | Drug price information for FOCALIN |
| Drug Sales Revenues: | Drug sales revenues for FOCALIN |
| What excipients (inactive ingredients) are in FOCALIN? | FOCALIN excipients list |
| DailyMed Link: | FOCALIN at DailyMed |
Recent Clinical Trials for FOCALIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cingulate Therapeutics | Phase 1/Phase 2 |
| Matthew J O'Brien, PhD, BCBA-D | Phase 4 |
| Matthew O'Brien | Phase 4 |
Pharmacology for FOCALIN
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Paragraph IV (Patent) Challenges for FOCALIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FOCALIN | Tablets | dexmethylphenidate hydrochloride | 2.5 mg | 021278 | 1 | 2004-07-27 |
| FOCALIN | Tablets | dexmethylphenidate hydrochloride | 5 mg and 10 mg | 021278 | 1 | 2004-05-27 |
US Patents and Regulatory Information for FOCALIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-001 | Nov 13, 2001 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-003 | May 26, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-001 | May 26, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-008 | Apr 21, 2011 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-002 | Nov 13, 2001 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-003 | Nov 13, 2001 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for FOCALIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-003 | Nov 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-003 | Nov 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-001 | Nov 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-001 | Nov 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-001 | Nov 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | FOCALIN | dexmethylphenidate hydrochloride | TABLET;ORAL | 021278-002 | Nov 13, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FOCALIN
See the table below for patents covering FOCALIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 135288 | CHRONIC BOLUS ADMINISTRATION OF D-THREO METHYLPHENIDATE | ⤷ Sign Up |
| Portugal | 1032389 | ⤷ Sign Up | |
| Canada | 2240329 | ADMINISTRATION AMELIOREE DE DOSES MULTIPLES DE MEDICAMENTS (IMPROVED DELIVERY OF MULTIPLE DOSES OF MEDICATIONS) | ⤷ Sign Up |
| Japan | 5412700 | ⤷ Sign Up | |
| Australia | 7976598 | ⤷ Sign Up | |
| Israel | 159313 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >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 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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