Rytary is a drug owned by Impax Laboratories Llc. It is protected by 9 US drug patents filed from 2015 to 2018. Out of these, 8 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 26, 2028. Details of Rytary's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7094427 | Combination immediate release controlled release levodopa/carbidopa dosage forms |
May, 2022
(2 years ago) |
Expired
|
| US9089607 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
| US8454998 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
| US8377474 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
| US8557283 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
| US9901640 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
| US9533046 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
| US9463246 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
| US9089608 | Controlled release formulations of levodopa and uses thereof |
Dec, 2028
(4 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rytary's patents.
Latest Legal Activities on Rytary's Patents
Given below is the list of recent legal activities going on the following patents of Rytary.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jul, 2024 | US9533046 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Apr, 2024 | US9463246 (Litigated) |
| Email Notification | 24 May, 2023 | US8377474 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) | 24 May, 2023 | US8377474 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jan, 2023 | US9089607 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jan, 2023 | US9089608 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Aug, 2021 | US9901640 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Mar, 2021 | US8557283 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Sep, 2020 | US8454998 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Aug, 2020 | US8377474 (Litigated) |
FDA has granted several exclusivities to Rytary. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rytary, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rytary.
Exclusivity Information
Rytary holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Rytary's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jan 07, 2018 |
Several oppositions have been filed on Rytary's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Rytary's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rytary patents.
Rytary's oppositions filed in EPO
Rytary has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 07, 2021, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP08866933A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP08866933A | Jan, 2021 | Luigi, Rumi | Granted and Under Opposition |
| EP08866933A | Jan, 2021 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Rytary is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rytary's family patents as well as insights into ongoing legal events on those patents.
Rytary's family patents
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Generic Launch
Generic Release Date:
Rytary's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 26, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rytary Generics:
Carbidopa; Levodopa is the generic name for the brand Rytary. 22 different companies have already filed for the generic of Rytary, with Impax Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rytary's generic
How can I launch a generic of Rytary before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rytary's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rytary's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Rytary -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 61.25 mg/245 mg | 10 Jun, 2015 | 1 | 26 Dec, 2028 | Non-Forfeiture | |
| 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg | 24 Jun, 2015 | 1 | 26 Dec, 2028 | Non-Forfeiture |
About Rytary
Rytary is a drug owned by Impax Laboratories Llc. It is used for treating Parkinson's disease and related conditions such as post-encephalitic parkinsonism and parkinsonism from carbon monoxide or manganese intoxication. Rytary uses Carbidopa; Levodopa as an active ingredient. Rytary was launched by Impax in 2015.
Can you believe Rytary received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Market Authorisation Date:
Rytary was approved by FDA for market use on 07 January, 2015.
Active Ingredient:
Rytary uses Carbidopa; Levodopa as the active ingredient. Check out other Drugs and Companies using Carbidopa; Levodopa ingredient
Treatment:
Rytary is used for treating Parkinson's disease and related conditions such as post-encephalitic parkinsonism and parkinsonism from carbon monoxide or manganese intoxication.
Dosage:
Rytary is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 36.25MG;145MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 48.75MG;195MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 61.25MG;245MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 23.75MG;95MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |