Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: June 24, 2017
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 Nextwave Pharms, Mallinckrodt, Tris Pharma Inc, Ucb Inc, Novel Labs Inc, Able, Impax Labs Inc, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Janssen Pharms, Actavis Elizabeth, Mylan Pharms Inc, Novartis, Rhodes Pharms, Barr Labs Inc, Abhai Inc, Cnty Line Pharms, Nostrum Labs Inc, Tedor Pharma Inc, Mayne Pharma, Pfizer Inc, Abhai Llc, Vintage Pharms, and Kremers Urban Pharms, and is included in forty-nine NDAs. There are twenty-eight patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 12 |
| Patents: | 28 |
| Applicants: | 28 |
| NDAs: | 49 |
| Drug Master File Entries: see list | 31 |
| Suppliers / Packagers: see list | 36 |
| Bulk Api Vendors: see list | 28 |
| Clinical Trials: see list | 2,522 |
| Patent Applications: see list | 3,499 |
| Therapeutic Class: | Central Nervous System Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | methylphenidate hydrochloride at DailyMed |
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 10MG | CAPSULE, EXTENDED RELEASE; ORAL |
| ► Subscribe | ► Subscribe | 60MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ► Subscribe | ► Subscribe | 50MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078873-001 | Jul 19, 2012 | AB2 | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pfizer Inc | QUILLICHEW ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 207960-003 | Dec 4, 2015 | RX | Yes | Yes | 8,287,903 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Nextwave Pharms | QUILLIVANT XR | methylphenidate hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100-001 | Sep 27, 2012 | RX | Yes | Yes | 8,465,765 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Tris Pharma Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | SOLUTION;ORAL | 091601-001 | Jul 23, 2010 | AA | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-003 | Dec 8, 2000 | AB | RX | Yes | Yes | 6,930,129*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-001 | Aug 1, 2000 | 5,082,668*PED | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-003 | Dec 8, 2000 | 4,612,008*PED | ► Subscribe | ||||||||||||||||||||||
Novartis | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-001 | Jun 5, 2002 | 5,837,284 | ► Subscribe | ||||||||||||||||||||||
Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-001 | Aug 1, 2000 | 4,519,801 | ► Subscribe | ||||||||||||||||||||||
Novartis | RITALIN-SR | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 018029-001 | Mar 30, 1982 | 4,137,300 | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,747,902 | Modified release formulations containing drug-ion exchange resin complexes | ► Subscribe | |||||||||||||||||||||||||||
| 6,793,936 | Multiparticulate modified release composition | ► Subscribe | |||||||||||||||||||||||||||
| 8,323,691 | Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms | ► Subscribe | |||||||||||||||||||||||||||
| 8,883,217 | Modified release formulations containing drug-ion exchange resin complexes | ► Subscribe | |||||||||||||||||||||||||||
| 9,198,864 | Modified release formulations containing drug-ion exchange resin complexes | ► 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.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norway | 20031843 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 334409 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1937218 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2002513392 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2007109104 | ► 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.
Serving 500+ biopharmaceutical companies globally:
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.
Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639
Follow DrugPatentWatch:
Join the 21,683 other biopharmaceutical professionals who get our Drug Patent Expiration Alerts:
