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COTEMPLA XR-ODT Drug Profile
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» See Plans and PricingWhen do Cotempla Xr-odt patents expire, and when can generic versions of Cotempla Xr-odt launch?
Cotempla Xr-odt is a drug marketed by Neos Theraps Inc and is included in one NDA. There are three patents protecting this drug.
This drug has two patent family members in two countries.
The generic ingredient in COTEMPLA XR-ODT is methylphenidate. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.
US ANDA Litigation and Generic Entry Outlook for Cotempla Xr-odt
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (methylphenidate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for COTEMPLA XR-ODT
| International Patents: | 2 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Patent Applications: | 4,463 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COTEMPLA XR-ODT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COTEMPLA XR-ODT |
| DailyMed Link: | COTEMPLA XR-ODT at DailyMed |
Pharmacology for COTEMPLA XR-ODT
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Paragraph IV (Patent) Challenges for COTEMPLA XR-ODT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COTEMPLA XR-ODT | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | methylphenidate | 205489 | 2017-09-01 |
US Patents and Regulatory Information for COTEMPLA XR-ODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neos Theraps Inc | COTEMPLA XR-ODT | methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489-001 | Jun 19, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Neos Theraps Inc | COTEMPLA XR-ODT | methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489-002 | Jun 19, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Neos Theraps Inc | COTEMPLA XR-ODT | methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489-001 | Jun 19, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Neos Theraps Inc | COTEMPLA XR-ODT | methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489-003 | Jun 19, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for COTEMPLA XR-ODT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2726066 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013003622 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
