Focalin XR Drug Patent Profile
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When do Focalin Xr patents expire, and when can generic versions of Focalin Xr launch?
Focalin Xr is a drug marketed by Sandoz and is included in one NDA.
The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Focalin Xr
A generic version of Focalin XR was approved as dexmethylphenidate hydrochloride by INTELLIPHARMACEUTICS on November 18th, 2013.
Summary for Focalin XR
Recent Clinical Trials for Focalin XR
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 XR
Drug Class | Central Nervous System Stimulant |
Physiological Effect | Central Nervous System Stimulation |
Anatomical Therapeutic Chemical (ATC) Classes for Focalin XR
Paragraph IV (Patent) Challenges for FOCALIN XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 25 mg | 021802 | 1 | 2011-09-30 |
FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 35 mg | 021802 | 1 | 2011-09-29 |
FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 40 mg | 021802 | 1 | 2010-12-20 |
FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 30 mg | 021802 | 1 | 2010-12-15 |
FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 15 mg | 021802 | 1 | 2007-05-14 |
FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 5 mg, 10 mg and 20 mg | 021802 | 1 | 2007-03-30 |
US Patents and Regulatory Information for Focalin XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-001 | May 26, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-003 | May 26, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-006 | Aug 11, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-004 | Aug 1, 2006 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 Focalin XR
International Patents for Focalin XR
See the table below for patents covering Focalin XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009514989 | ⤷ Try a Trial | |
Peru | 13222000 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2008079102 | ⤷ Try a Trial | |
Mexico | PA04000249 | METODOS PARA TRATAMIENTO DE TRASTORNOS COGNITIVOS Y MENOPAUSICOS CON D-TREO-METILFENIDATO. (METHODS FOR TREATMENT OF COGNITIVE AND MENOPAUSAL DISORDERS WITH D-THREO METHYLPHENIDATE.) | ⤷ Try a Trial |
Japan | 2010265299 | IMPROVED DELIVERY OF MULTIPLE DOSES OF MEDICATION | ⤷ Try a Trial |
Denmark | 1001772 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |