RYTARY Drug Patent Profile
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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 eight patents protecting this drug and two Paragraph IV challenges.
This drug has twenty-five patent family members in twelve countries.
The generic ingredient in RYTARY is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rytary
A generic version of RYTARY was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28th, 1992.
Summary for RYTARY
International Patents: | 25 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 1 |
Patent Applications: | 580 |
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 |
What excipients (inactive ingredients) are in RYTARY? | RYTARY excipients list |
DailyMed Link: | RYTARY at DailyMed |
Recent Clinical Trials for RYTARY
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institutes of Health (NIH) | Phase 2 |
Northwestern University | Phase 2 |
Northwestern Medical Group | Phase 2 |
Pharmacology for RYTARY
Drug Class | Aromatic Amino Acid |
Anatomical Therapeutic Chemical (ATC) Classes for RYTARY
Paragraph IV (Patent) Challenges for RYTARY
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RYTARY | Extended-release Capsules | carbidopa; levodopa | 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg | 203312 | 1 | 2015-06-24 |
RYTARY | Extended-release Capsules | carbidopa; levodopa | 61.25 mg/245 mg | 203312 | 1 | 2015-06-10 |
US Patents and Regulatory Information for RYTARY
RYTARY is protected by fifteen US patents.
Patents protecting RYTARY
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE
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 | 203312-003 | Jan 7, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 RYTARY
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-001 | Jan 7, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RYTARY
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Amneal Pharma Europe Ltd | Numient | levodopa, carbidopa | EMEA/H/C/002611 Symptomatic treatment of adult patients with Parkinson’s disease |
Withdrawn | no | no | no | 2015-11-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for RYTARY
When does loss-of-exclusivity occur for RYTARY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 08343787
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 11014
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1910113
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 34963
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6756
Estimated Expiration: ⤷ Try a Trial
Patent: 8520
Estimated Expiration: ⤷ Try a Trial
Patent: 3053
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 83725
Estimated Expiration: ⤷ Try a Trial
Patent: 33373
Estimated Expiration: ⤷ Try a Trial
Patent: 28205
Estimated Expiration: ⤷ Try a Trial
Patent: 11507956
Estimated Expiration: ⤷ Try a Trial
Patent: 15187178
Estimated Expiration: ⤷ Try a Trial
Patent: 17014295
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 10007207
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 6870
Estimated Expiration: ⤷ Try a Trial
Patent: 2302
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1005309
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1451564
Estimated Expiration: ⤷ Try a Trial
Patent: 1569604
Estimated Expiration: ⤷ Try a Trial
Patent: 1752080
Estimated Expiration: ⤷ Try a Trial
Patent: 100099731
Estimated Expiration: ⤷ Try a Trial
Patent: 130113533
Estimated Expiration: ⤷ Try a Trial
Patent: 150133854
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 04348
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering RYTARY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 200633730 | Oral disintegrating dosage forms | ⤷ Try a Trial |
Japan | 2015187178 | レボドパの放出制御製剤及びその使用 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) | ⤷ Try a Trial |
Israel | 164856 | COMBINATION IMMEDIATE RELEASE CONTROLLED RELEASE LEVODOPA/CARBIDOPA DOSAGE FORMS | ⤷ Try a Trial |
South Korea | 101752080 | ⤷ Try a Trial | |
Spain | 2606463 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |