METHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for methylphenidate hydrochloride and what is the scope of patent protection?
Methylphenidate hydrochloride
is the generic ingredient in fifteen branded drugs marketed by Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Aytu Biopharma, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Sandoz, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Nextwave Pharms, Janssen Pharms, Lannett Co Inc, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Osmotica Pharm Us, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Novartis, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-five NDAs. There are forty-five patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Methylphenidate hydrochloride has one hundred and twenty-one patent family members in twenty-two countries.
There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for METHYLPHENIDATE HYDROCHLORIDE
International Patents: | 121 |
US Patents: | 45 |
Tradenames: | 15 |
Applicants: | 50 |
NDAs: | 85 |
Drug Master File Entries: | 23 |
Finished Product Suppliers / Packagers: | 46 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 418 |
Patent Applications: | 4,944 |
Drug Prices: | Drug price trends for METHYLPHENIDATE HYDROCHLORIDE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METHYLPHENIDATE HYDROCHLORIDE |
What excipients (inactive ingredients) are in METHYLPHENIDATE HYDROCHLORIDE? | METHYLPHENIDATE HYDROCHLORIDE excipients list |
DailyMed Link: | METHYLPHENIDATE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for METHYLPHENIDATE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Florida | Early Phase 1 |
Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz | Phase 2 |
Institute of Medical Sciences of the University of Opole | Phase 2 |
Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 20MG | TABLET, EXTENDED RELEASE, CHEWABLE;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 |
Anatomical Therapeutic Chemical (ATC) Classes for METHYLPHENIDATE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for METHYLPHENIDATE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
QUILLICHEW ER | Extended-release Chewable Tablets | methylphenidate hydrochloride | 20 mg, 30 mg and 40 mg | 207960 | 1 | 2016-04-25 |
APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 30 mg | 205831 | 1 | 2016-03-28 |
APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 15 mg, 20 mg, 40 mg and 50 mg | 205831 | 1 | 2015-12-28 |
APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 10 mg | 205831 | 1 | 2015-12-24 |
APTENSIO XR | Extended-release Capsules | methylphenidate hydrochloride | 60 mg | 205831 | 1 | 2015-12-23 |
QUILLIVANT XR | Extended-release Oral Suspension | methylphenidate hydrochloride | 5 mg/mL | 202100 | 2013-08-02 | |
METHYLIN | Oral Solution | methylphenidate hydrochloride | 5 mg/5 mL 10 mg/5 mL | 021419 | 1 | 2010-04-13 |
RITALIN LA | Extended-release Capsules | methylphenidate hydrochloride | 10 mg | 021284 | 1 | 2007-05-21 |
METADATE CD | Extended-release Capsules | methylphenidate hydrochloride | 40 mg | 021259 | 1 | 2007-03-15 |
RITALIN LA | Extended-release Capsules | methylphenidate hydrochloride | 20 mg, 30 mg and 40 mg | 021284 | 2006-08-21 | |
CONCERTA | Extended-release Tablets | methylphenidate hydrochloride | 18 mg*, 27 mg, 36 mg and 54 mg | 021121 | 2005-07-19 | |
METADATE CD | Extended-release Capsules | methylphenidate hydrochloride | 10 mg, 20 mg and 30 mg | 021259 | 1 | 2005-05-13 |
US Patents and Regulatory Information for METHYLPHENIDATE HYDROCHLORIDE
Expired US Patents for METHYLPHENIDATE HYDROCHLORIDE
International Patents for METHYLPHENIDATE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 201702716 | METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER | ⤷ Sign Up |
Singapore | 10201912626W | METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER | ⤷ Sign Up |
European Patent Office | 2884961 | COMPRIMÉ À CROQUER DE MÉTHYLPHÉNIDATE À LIBÉRATION MODIFIÉE (METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET) | ⤷ Sign Up |
Denmark | 2688557 | ⤷ Sign Up | |
China | 107205954 | ⤷ Sign Up | |
China | 110151731 | ⤷ Sign Up | |
Canada | 2902911 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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