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Serving leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Julphar
Chubb
McKinsey
Deloitte
Accenture
Express Scripts
Queensland Health
Cerilliant

Generated: January 22, 2018

DrugPatentWatch Database Preview

Methylphenidate hydrochloride - Generic Drug Details

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What are the generic drug sources for methylphenidate hydrochloride and what is the scope of methylphenidate hydrochloride patent protection?

Methylphenidate hydrochloride
is the generic ingredient in twelve branded drugs marketed by Rhodes Pharms, Ucb Inc, Barr Labs Inc, Impax Labs Inc, Mallinckrodt Inc, Mayne Pharma, Teva Pharms, Novartis, Nextwave Pharms, Mallinckrodt, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Tedor Pharma Inc, Pfizer Inc, Janssen Pharms, Able, Actavis Elizabeth, Cnty Line Pharms, Kremers Urban Pharms, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Ascent Pharms Inc, Sun Pharm Inds Inc, and Vintage Pharms, and is included in fifty-one NDAs. There are twenty-seven patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylphenidate hydrochloride has three hundred and eight patent family members in thirty-six countries.

There are thirty-one drug master file entries for methylphenidate hydrochloride. Thirty-five suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for methylphenidate hydrochloride
Pharmacology for methylphenidate hydrochloride
Tentative approvals for METHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe10MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Subscribe➤ Subscribe60MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Subscribe➤ Subscribe50MGCAPSULE, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for methylphenidate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cnty Line Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 206840-002 Sep 15, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis RITALIN methylphenidate hydrochloride TABLET;ORAL 010187-010 Approved Prior to Jan 1, 1982 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Inc QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-002 Dec 4, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Impax Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205105-001 Jul 28, 2016 AB2 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 077707-001 Jul 19, 2012 AB2 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharm Inds Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 090710-001 Mar 15, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ucb Inc METADATE CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021259-006 Feb 19, 2006 AB2 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for methylphenidate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-003 Jun 5, 2002 ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ➤ Subscribe ➤ Subscribe
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-003 Jun 5, 2002 ➤ Subscribe ➤ Subscribe
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-004 Apr 10, 2004 ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ➤ Subscribe ➤ Subscribe
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for methylphenidate hydrochloride

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
8,936,810 Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms ➤ Subscribe
9,844,545 Methylphenidate extended release chewable tablet ➤ Subscribe
9,198,864 Modified release formulations containing drug-ion exchange resin complexes ➤ Subscribe
9,675,703 Modified release formulations containing drug - ion exchange resin complexes ➤ Subscribe
7,521,067 Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms ➤ Subscribe
6,673,367 Controlled/modified release oral methylphenidate formulations ➤ Subscribe
6,793,936 Multiparticulate modified release composition ➤ Subscribe
6,902,742 Multiparticulate modified release composition ➤ Subscribe
8,747,902 Modified release formulations containing drug-ion exchange resin complexes ➤ Subscribe
6,730,325 Multiparticulate modified release composition ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for methylphenidate hydrochloride

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Accenture
Cantor Fitzgerald
QuintilesIMS
US Army
Teva
Chubb
Harvard Business School
McKesson

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.

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