.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

FOCALIN Drug Profile

« Back to Dashboard
Focalin is a drug marketed by Novartis and is included in two NDAs. It is available from two suppliers. There are eight patents protecting this drug and eight Paragraph IV challenges.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in FOCALIN is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Twenty suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for Tradename: FOCALIN

Patents:8
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: FOCALIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010RXYes7,431,944► subscribeY ► subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005RXNo6,355,656► subscribeY ► subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006RXNo7,431,944► subscribeY ► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: FOCALIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-002Nov 13, 20016,255,325► subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-002Nov 13, 20016,355,656► subscribe
Novartis
FOCALIN
dexmethylphenidate hydrochloride
TABLET;ORAL021278-001Nov 13, 20015,908,850► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: FOCALIN

Drugname Dosage Strength RLD Submissiondate
dexmethylphenidateExtended-release capsules25 mgFocalin XR9/30/2011
dexmethylphenidateExtended-release capsules35 mgFocalin XR9/29/2011
dexmethyphenidate hydrochlorideExtended-release Capsule40 mgFocalin XR12/20/2010
dexmethylphenidate hydrochlorideExtended-release Capsule30 mgFocalin XR12/15/2010
dexmethylphenidate hydrochlorideExtended-release Capsules15 mgFocalin XR5/14/2007
dexmethylphenidate hydrochlorideExtended-release Capsules5mg, 10mg and 20 mgFocalin XR3/30/2007
dexmethylphenidate hydrochlorideTablets2.5 mgFocalin7/27/2004
dexmethylphenidate hydrochlorideTablets5 mg and 10 mgFocalin5/27/2004

Non-Orange Book Patents for Tradename: FOCALIN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,733,756 Lactams and processes for stereoselective enrichment of lactams, amides, and esters► subscribe
6,486,177 Methods for treatment of cognitive and menopausal disorders with D-threo methylphenidate► subscribe
6,635,284 Delivery of multiple doses of medications► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: FOCALIN

Country Document Number Estimated Expiration
Germany1001772► subscribe
European Patent Office1032389► subscribe
South Korea20040029360► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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 verifification 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.

`abc