DrugPatentWatch Database Preview
Methylphenidate hydrochloride - Generic Drug Details
What are the generic drug sources for methylphenidate hydrochloride and what is the scope of patent protection?
Methylphenidate hydrochloride
is the generic ingredient in fourteen branded drugs marketed by Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Lannett Co Inc, Actavis Elizabeth, Barr Labs Inc, Granules Pharms, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Breckenridge, Novel Labs Inc, Tris Pharma Inc, Wes Pharma Inc, Ascent Pharms Inc, Rising, Nextwave Pharms, Janssen Pharms, Able, Actavis Labs Fl, Alvogen Pine Brook, Amneal Pharms, Andor Pharms, Ani Pharms Inc, Cnty Line Pharms, Heritage Pharma, Mylan, Osmotica, Par Pharm, Watson Labs, Abhai Inc, Aurolife Pharma Llc, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in seventy NDAs. There are thirty-seven patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Methylphenidate hydrochloride has two hundred and ninety-three patent family members in thirty-seven countries.
There are thirty-two drug master file entries for methylphenidate hydrochloride. Forty-one suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for methylphenidate hydrochloride
| International Patents: | 293 |
| US Patents: | 37 |
| Tradenames: | 14 |
| Applicants: | 42 |
| NDAs: | 70 |
| Drug Master File Entries: | 32 |
| Suppliers / Packagers: | 41 |
| Bulk Api Vendors: | 44 |
| Clinical Trials: | 368 |
| Patent Applications: | 4,167 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for methylphenidate hydrochloride |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for methylphenidate hydrochloride |
| DailyMed Link: | methylphenidate hydrochloride at DailyMed |
Recent Clinical Trials for methylphenidate hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Taiwan University Hospital | N/A |
| National Cancer Institute (NCI) | Phase 2/Phase 3 |
| M.D. Anderson Cancer Center | Phase 2/Phase 3 |
Recent Litigation for methylphenidate hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| Recro Gainesville LLC v. Actavis Laboratories FL, Inc. | 2017-10-30 |
| Alza Corporation v. Amneal Pharmaceuticals of New York, LLC | 2016-10-07 |
Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 10MG | CAPSULE, EXTENDED RELEASE; ORAL |
| Start Trial | Start Trial | 60MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Start Trial | Start Trial | 50MG | CAPSULE, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for methylphenidate hydrochloride
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Synonyms for methylphenidate hydrochloride
| 113-45-1 (Parent) |
| 2-Piperidineacetic acid, .alpha.-phenyl-, methyl ester, hydrochloride |
| 2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride |
| 2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (R*,R*)-(+-)- |
| 298-59-9 |
| 298M599 |
| AC1L1SQ4 |
| AC1Q5YRN |
| AKOS016010356 |
| alpha-phenyl-2-piperidineacetic acid methyl ester hydrochloride |
| AN-23356 |
| API0003340 |
| CAS-298-59-9 |
| CC-30903 |
| CCG-213572 |
| CCRIS 6258 |
| Centedrin |
| Centedrine |
| CHEBI:31836 |
| CHEMBL1722 |
| ciba 4311b |
| Concerta (TN) |
| CS-4658 |
| D01296 |
| Daytrana |
| DSSTox_CID_886 |
| DSSTox_GSID_20886 |
| DSSTox_RID_75843 |
| DTXSID8020886 |
| EINECS 206-065-3 |
| FT-0603372 |
| FT-0672046 |
| FT-0672047 |
| H-Tic-OtBu.HCl |
| HY-B1091A |
| JUMYIBMBTDDLNG-UHFFFAOYSA-N |
| LS-42 |
| Medikinet |
| Meridil hydrochloride |
| Metadate |
| Metadate (TN) |
| Metadate CD |
| Metadate ER |
| Methyl .alpha.-phenyl-2-piperidineacetate hydrochloride |
| methyl 2-phenyl-2-(2-piperidyl)acetate hydrochloride |
| Methyl 2-phenyl-2-(piperidin-2-yl)acetate hydrochloride |
| methyl 2-phenyl-2-piperidin-2-ylacetate hydrochloride |
| methyl alpha-phenyl-2-piperidine-acetate hydrochloride |
| Methyl alpha-phenyl-2-piperidineacetate hydrochloride |
| Methyl Phenidylacetate Hydrochloride |
| methyl phenyl(piperidin-2-yl)acetate hydrochloride |
| Methylin |
| Methylin ER |
| Methylphenidan Hydrochloride |
| Methylphenidate (hydrochloride) |
| Methylphenidate HCl |
| Methylphenidate hydrochloride (JAN/USP) |
| Methylphenidate hydrochloride [USAN:JAN] |
| Methylphenidate hydrochloride [USP:JAN] |
| Methylphenidate Hydrochloride ER |
| Methylphenidate hydrochloride solution, (Racemic mixture), ampule of 1 mL, 1.0 mg/mL in methanol (as free base), certified reference material |
| Methylphenidate hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Methylphenidate Hydrochloride(Ritalin hydrochloride) |
| METHYLPHENIDATE HYDROCHLORIDE(SEE ALSO: METHYLPHENIDATE, CAS 113-45-1, NTPNO M20344) |
| Methylphenidate.HCl |
| Methylphenidate(Ritalin) |
| Methylphenidylacetate hydrochloride |
| Metilfenidat hydrochloride |
| MLS003922100 |
| NCGC00091942-01 |
| NCGC00257863-01 |
| NSC 169868 |
| NSC-169868 |
| NSC-759278 |
| NSC169868 |
| NSC759278 |
| Pharmakon1600-01505907 |
| PMS-Methylphenidate |
| QuilliChew ER |
| Quillivant XR |
| Quillivant xr (TN) |
| Rilaline |
| Rilatine |
| Ritalin |
| Ritalin (TN) |
| Ritalin hy drochloride |
| Ritalin hydrochloride |
| Ritalin LA |
| Ritalin SR |
| Ritalin-SR |
| SC-83308 |
| SCHEMBL41067 |
| SMR000058998 |
| threo-Methyl |A-phenyl-|A-(2-piperidyl)acetate hydrochloride |
| Tox21_111186 |
| Tox21_200309 |
| TRANSGENIC MODEL EVALUATION (METHYLPHENIDATE HYDROCHLORIDE) (SEE ALSO: METHYLPHENIDATE HYDROCHLORIDE) |
| WLN: T6MTJ BYR & VO1 & GH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 203583-003 | Sep 29, 2015 | AB2 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Impax Labs Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205105-001 | Jul 28, 2016 | AB2 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Purdue Pharma Lp | ADHANSIA XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212038-004 | Feb 27, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Breckenridge | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET;ORAL | 207587-003 | Mar 3, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start 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 methylphenidate hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-004 | Apr 1, 2002 | Start Trial | Start Trial |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-003 | Dec 8, 2000 | Start Trial | Start Trial |
| Novartis | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-001 | Jun 5, 2002 | Start Trial | Start Trial |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-004 | Apr 1, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for methylphenidate hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2007203497 | Start Trial |
| Argentina | 021858 | Start Trial |
| Austria | 395916 | Start Trial |
| Canada | 2902911 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.