FOCALIN XR Drug Patent Profile
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When do Focalin Xr patents expire, and what generic alternatives are available?
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. 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 Xr
A generic version of FOCALIN XR 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 XR?
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- What is Average Wholesale Price for FOCALIN XR?
Summary for FOCALIN XR
![FOCALIN XR drug patent expirations Drug patent expirations by year for FOCALIN XR](/p/graph/s/t/FOCALIN_XR-patent-expirations.png)
![Drug Prices for FOCALIN XR](/p/graph/drug-price/FOCALIN+XR.png)
See drug prices for FOCALIN XR
![Drug Sales Revenue Trends for FOCALIN XR](/p/graph/drug-sales-revenues/FOCALIN+XR.png)
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | 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 | 021802-006 | Aug 11, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-004 | Aug 1, 2006 | AB | RX | Yes | No | ⤷ 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 XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-007 | Apr 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-002 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-008 | Apr 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-004 | Aug 1, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-005 | Oct 23, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FOCALIN XR
See the table below for patents covering FOCALIN XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | 230454 | Metilfenidátot tartalmazó módosított felszabadulású sokszemcsés készítmény (Multiparticulate modified release composition of methylphenidate) | ⤷ Sign Up |
China | 101484170 | ⤷ Sign Up | |
Australia | 738521 | ⤷ Sign Up | |
Japan | 2009514989 | ⤷ Sign Up | |
South Korea | 20080047509 | ⤷ Sign Up | |
Norway | 20090158 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |