METHYLIN ER Drug Patent Profile
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Which patents cover Methylin Er, and when can generic versions of Methylin Er launch?
Methylin Er is a drug marketed by Specgx Llc and is included in one NDA.
The generic ingredient in METHYLIN ER is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methylin Er
A generic version of METHYLIN ER was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
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Questions you can ask:
- What is the 5 year forecast for METHYLIN ER?
- What are the global sales for METHYLIN ER?
- What is Average Wholesale Price for METHYLIN ER?
Summary for METHYLIN ER
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 3 |
| Patent Applications: | 3,514 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | METHYLIN ER at DailyMed |
Recent Clinical Trials for METHYLIN ER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nicoleta Stoicea | Phase 1 |
| Boston Children's Hospital | Phase 1 |
| Dana-Farber Cancer Institute | Phase 1 |
Pharmacology for METHYLIN ER
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
US Patents and Regulatory Information for METHYLIN ER
| 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 ER | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 075629-001 | May 9, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
