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Methylphenidate hydrochloride - Generic Drug Details
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 thirteen branded drugs marketed by Rhodes Pharms, Ironshore Pharms, Lannett Co Inc, Barr Labs Inc, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave Pharms, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Wes Pharma Inc, Ascent Pharms Inc, Rising Pharms, Alvogen Pine Brook, Janssen Pharms, Able, Actavis Elizabeth, Actavis Labs Fl, Amneal Pharms, Ani Pharms Inc, Cnty Line Pharms, Granules Pharms, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Aurolife Pharma Llc, Bionpharma Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in sixty-two NDAs. There are thirty-six 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 thirty-four patent family members in thirty-six countries.
There are thirty-two drug master file entries for methylphenidate hydrochloride. Forty-two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for methylphenidate hydrochloride
| International Patents: | 334 |
| US Patents: | 36 |
| Tradenames: | 13 |
| Applicants: | 36 |
| NDAs: | 62 |
| Drug Master File Entries: | 32 |
| Suppliers / Packagers: | 42 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 366 |
| Patent Applications: | 3,931 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for methylphenidate hydrochloride |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for methylphenidate hydrochloride |
| DailyMed Link: | methylphenidate hydrochloride at DailyMed |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nextwave Pharms | QUILLICHEW ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 207960-003 | Dec 4, 2015 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-001 | Aug 1, 2000 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Ascent Pharms Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET;ORAL | 207416-003 | Sep 22, 2015 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Mylan Pharms Inc | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 206726-004 | Oct 21, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Rhodes Pharms | APTENSIO XR | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831-003 | Apr 17, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 methylphenidate hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-002 | Aug 1, 2000 | ➤ Sign Up | ➤ Sign Up |
| Novartis | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-002 | Jun 5, 2002 | ➤ Sign Up | ➤ Sign Up |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-004 | Apr 1, 2002 | ➤ Sign Up | ➤ Sign Up |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-003 | Dec 8, 2000 | ➤ Sign Up | ➤ Sign Up |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-004 | Apr 1, 2002 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for methylphenidate hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2618603 | ➤ Sign Up |
| Spain | 2229783 | ➤ Sign Up |
| China | 1352549 | ➤ Sign Up |
| South Africa | 9709605 | ➤ Sign Up |
| Japan | 2012184235 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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