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?
- What are the global sales for FOCALIN?
- What is Average Wholesale Price for FOCALIN?
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 O'Brien | Phase 4 |
Matthew J O'Brien, PhD, BCBA-D | 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
Expired US Patents for FOCALIN
International Patents for FOCALIN
See the table below for patents covering FOCALIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2465077 | ADMINISTRATION AMELIOREE DE DOSES MULTIPLES DE MEDICAMENTS (IMPROVED DELIVERY OF MULTIPLE DOSES OF MEDICATIONS) | ⤷ Subscribe |
Canada | 2453510 | TRAITEMENT DE LA FATIGUE ET DES EFFETS SECONDAIRES COGNITIFS ASSOCIES AU CANCER, AUX TRAITEMENTS CONTRE LE CANCER ET A LA MENOPAUSE AU MOYEN DE D-THREO-METHYPHENIDATE (TREATMENT OF FATIGUE AND COGNITIVE SIDE EFFECTS ASSOCIATED WITH CANCER, CANCER TREATMENTS AND MENOPAUSE WITH D-THREO-METHYPHENIDATE) | ⤷ Subscribe |
Australia | 7834398 | ⤷ Subscribe | |
Hong Kong | 1077501 | ⤷ Subscribe | |
Canada | 2241611 | ADMINISTRATION CHRONIQUE D'UN BOL DE D-THREO METHYLPHENIDATE (CHRONIC, BOLUS ADMINISTRATION OF D-THREO METHYLPHENIDATE) | ⤷ Subscribe |
New Zealand | 530211 | D-threo methylphenidate substantially free of the L-threo form to treat fatigue, neurobehavioral slowing and other cogitative disorders exacerbated by treatments associated with cancer therapy | ⤷ Subscribe |
Germany | 69831869 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
FOCALIN Market Analysis and Financial Projection Experimental
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