METHYLIN Drug Patent Profile
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When do Methylin patents expire, and what generic alternatives are available?
Methylin is a drug marketed by Specgx Llc and is included in three NDAs. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has ten patent family members in nine countries.
The generic ingredient in METHYLIN is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methylin
A generic version of METHYLIN was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
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Summary for METHYLIN
| International Patents: | 10 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,491 |
| Drug Prices: | Drug price information for METHYLIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METHYLIN |
| What excipients (inactive ingredients) are in METHYLIN? | METHYLIN excipients list |
| DailyMed Link: | METHYLIN at DailyMed |
Recent Clinical Trials for METHYLIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nicoleta Stoicea | Phase 1 |
| Boston Children’s Hospital | Phase 1 |
| Boston Children's Hospital | Phase 1 |
Pharmacology for METHYLIN
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Paragraph IV (Patent) Challenges for METHYLIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| METHYLIN | Oral Solution | methylphenidate hydrochloride | 5 mg/5 mL 10 mg/5 mL | 021419 | 1 | 2010-04-13 |
US Patents and Regulatory Information for METHYLIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | METHYLIN | methylphenidate hydrochloride | SOLUTION;ORAL | 021419-001 | Dec 19, 2002 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Specgx Llc | METHYLIN ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075629-002 | May 9, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Specgx Llc | METHYLIN | methylphenidate hydrochloride | TABLET, CHEWABLE;ORAL | 021475-002 | Apr 15, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | METHYLIN | methylphenidate hydrochloride | SOLUTION;ORAL | 021419-002 | Dec 19, 2002 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Specgx Llc | METHYLIN | methylphenidate hydrochloride | TABLET, CHEWABLE;ORAL | 021475-001 | Apr 15, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | METHYLIN ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075629-001 | May 9, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 METHYLIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Specgx Llc | METHYLIN | methylphenidate hydrochloride | SOLUTION;ORAL | 021419-001 | Dec 19, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Specgx Llc | METHYLIN | methylphenidate hydrochloride | SOLUTION;ORAL | 021419-002 | Dec 19, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for METHYLIN
See the table below for patents covering METHYLIN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2007508313 | ⤷ Sign Up | |
| Canada | 2540052 | SOLUTION DE METHYLPHENIDATE ET PROCEDES ASSOCIES D'ADMINISTRATION ET DE PRODUCTION (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION) | ⤷ Sign Up |
| Mexico | PA06003725 | SOLUCION DE FENIDATO DE METILO Y METODOS ASOCIADOS DE ADMINISTRACION Y PRODUCCION. (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION.) | ⤷ Sign Up |
| China | 1867359 | Methylphenidate solution and associated methods of administration and produciton | ⤷ Sign Up |
| Australia | 2004280240 | Methylphenidate solution and associated methods of administration and production | ⤷ Sign Up |
| Japan | 4959335 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >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 verification 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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