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 nine patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-eight 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-six 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 MAYNE PHARMA on August 28th, 1992.
Summary for RYTARY
| International Patents: | 38 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 1 |
| Patent Applications: | 926 |
| 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 sixteen US patents.
Patents protecting RYTARY
Combination immediate release controlled release levodopa/carbidopa dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Controlled release formulations of levodopa and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | 203312-002 | Jan 7, 2015 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 | 203312-001 | Jan 7, 2015 | See Plans and Pricing | See Plans and Pricing |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | See Plans and Pricing | See Plans and Pricing |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | See Plans and Pricing | See Plans and Pricing |
| Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-002 | Jan 7, 2015 | See Plans and Pricing | See Plans and Pricing |
| >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: See Plans and Pricing
Canada
Patent: 11014
Estimated Expiration: See Plans and Pricing
China
Patent: 1910113
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 34963
Estimated Expiration: See Plans and Pricing
Israel
Patent: 6756
Estimated Expiration: See Plans and Pricing
Patent: 8520
Estimated Expiration: See Plans and Pricing
Patent: 3053
Estimated Expiration: See Plans and Pricing
Japan
Patent: 83725
Estimated Expiration: See Plans and Pricing
Patent: 33373
Estimated Expiration: See Plans and Pricing
Patent: 28205
Estimated Expiration: See Plans and Pricing
Patent: 11507956
Estimated Expiration: See Plans and Pricing
Patent: 15187178
Estimated Expiration: See Plans and Pricing
Patent: 17014295
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 10007207
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 6870
Estimated Expiration: See Plans and Pricing
Patent: 2302
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1005309
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1451564
Estimated Expiration: See Plans and Pricing
Patent: 1569604
Estimated Expiration: See Plans and Pricing
Patent: 1752080
Estimated Expiration: See Plans and Pricing
Patent: 100099731
Estimated Expiration: See Plans and Pricing
Patent: 130113533
Estimated Expiration: See Plans and Pricing
Patent: 150133854
Estimated Expiration: See Plans and Pricing
Spain
Patent: 04348
Estimated Expiration: See Plans and Pricing
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 |
|---|---|---|---|
| Canada | 2711014 | FORMULATIONS À LIBERATION CONTRÔLEE DE LEVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) | See Plans and Pricing |
| European Patent Office | 2234963 | FORMULATIONS À LIBÉRATION CONTRÔLÉE DE LÉVODOPA ET LEURS UTILISATIONS (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) | See Plans and Pricing |
| Mexico | 2010007207 | FORMULACIONES DE LIBERACION CONTROLADA DE LEVODOPA Y USOS DE LAS MISMAS. (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF.) | See Plans and Pricing |
| Spain | 2804348 | See Plans and Pricing | |
| China | 101910113 | Controlled release formulations of levodopa and uses thereof | See Plans and Pricing |
| South Korea | 20150133854 | 레보도파 방출 제어형 제제 및 이의 용도 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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