RITALIN Drug Patent Profile
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When do Ritalin patents expire, and what generic alternatives are available?
Ritalin is a drug marketed by Sandoz and Novartis and is included in three NDAs.
The generic ingredient in RITALIN 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 Ritalin
A generic version of RITALIN was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
Summary for RITALIN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 123 |
| Patent Applications: | 3,549 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RITALIN |
| Drug Sales Revenues: | Drug sales revenues for RITALIN |
| What excipients (inactive ingredients) are in RITALIN? | RITALIN excipients list |
| DailyMed Link: | RITALIN at DailyMed |
Recent Clinical Trials for RITALIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kuwait University | Early Phase 1 |
| University of Haifa | Phase 2 |
| Maccabi Healthcare Services, Israel | Phase 2/Phase 3 |
Pharmacology for RITALIN
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Anatomical Therapeutic Chemical (ATC) Classes for RITALIN
US Patents and Regulatory Information for RITALIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | RITALIN | methylphenidate hydrochloride | TABLET;ORAL | 010187-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-003 | Jun 5, 2002 | AB1 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-004 | Apr 10, 2004 | AB1 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | RITALIN LA | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284-005 | Oct 27, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sandoz | RITALIN | methylphenidate hydrochloride | TABLET;ORAL | 010187-006 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | RITALIN | methylphenidate hydrochloride | TABLET;ORAL | 010187-010 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
