Rytary Patent Expiration

Rytary is a drug owned by Impax Laboratories Inc. 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
US9901640 Controlled release formulations of levodopa and uses thereof
Dec, 2028

(4 years from now)

Active
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
US9463246 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
US9089608 Controlled release formulations of levodopa and uses thereof
Dec, 2028

(4 years from now)

Active


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

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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
Patent litigations
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

Rytary has patent protection in a total of 14 countries. It's US patent count contributes only to 41.7% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Rytary.

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 Inc. 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 Labs Inc in 2015.

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
61.25MG;245MG CAPSULE, EXTENDED RELEASE Prescription ORAL
23.75MG;95MG CAPSULE, EXTENDED RELEASE Prescription ORAL
48.75MG;195MG CAPSULE, EXTENDED RELEASE Prescription ORAL