CONCERTA Drug Patent Profile
✉ Email this page to a colleague
When do Concerta patents expire, and when can generic versions of Concerta launch?
Concerta is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in CONCERTA 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 Concerta
A generic version of CONCERTA was approved as methylphenidate hydrochloride by SPECGX LLC on November 27th, 1998.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for CONCERTA?
- What are the global sales for CONCERTA?
- What is Average Wholesale Price for CONCERTA?
Summary for CONCERTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 92 |
| Patent Applications: | 4,490 |
| Drug Prices: | Drug price information for CONCERTA |
| Drug Sales Revenues: | Drug sales revenues for CONCERTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CONCERTA |
| What excipients (inactive ingredients) are in CONCERTA? | CONCERTA excipients list |
| DailyMed Link: | CONCERTA at DailyMed |
Recent Clinical Trials for CONCERTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Lausanne | Phase 3 |
| Netherlands Institute for the Study of Crime | Phase 3 |
| University of Geneva, Switzerland | Phase 3 |
Pharmacology for CONCERTA
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Paragraph IV (Patent) Challenges for CONCERTA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CONCERTA | Extended-release Tablets | methylphenidate hydrochloride | 18 mg*, 27 mg, 36 mg and 54 mg | 021121 | 2005-07-19 |
US Patents and Regulatory Information for CONCERTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-001 | Aug 1, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-003 | Dec 8, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-004 | Apr 1, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-002 | Aug 1, 2000 | AB | RX | Yes | 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 CONCERTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CONCERTA
See the table below for patents covering CONCERTA around the world.
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
