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RYTARY Drug Profile
» See Plans and Pricing
When do Rytary patents expire, and when can generic versions of Rytary launch?
Rytary is a drug marketed by Impax Labs Inc and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-seven patent family members in fourteen countries.
The generic ingredient in RYTARY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
US ANDA Litigation and Generic Entry Outlook for Rytary
Annual sales in 2018 were $79mm indicating the motivation for generic entry (peak sales were $108mm in 2015).
There have been four patent litigation cases 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.
Indicators of Generic Entry
Summary for RYTARY
| International Patents: | 37 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 3 |
| Patent Applications: | 33 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RYTARY |
| Drug Sales Revenues: | Drug sales revenues for RYTARY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RYTARY |
| DailyMed Link: | RYTARY at DailyMed |
Pharmacology for RYTARY
| Drug Class | Aromatic Amino Acid |
Paragraph IV (Patent) Challenges for RYTARY
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RYTARY | CAPSULE, EXTENDED RELEASE;ORAL | carbidopa; levodopa | 203312 | 2015-06-24 |
| RYTARY | CAPSULE, EXTENDED RELEASE;ORAL | carbidopa; levodopa | 203312 | 2015-06-10 |
US Patents and Regulatory Information for RYTARY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 RYTARY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2921170 | Start Trial |
| South Korea | 101569604 | Start Trial |
| Japan | 6033373 | Start Trial |
| Spain | 2606463 | Start Trial |
| South Korea | 20150133854 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007016679 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
