CREXONT Drug Patent Profile
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When do Crexont patents expire, and when can generic versions of Crexont launch?
Crexont is a drug marketed by Impax and is included in one NDA. There are thirty patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in CREXONT is carbidopa; levodopa. There is one drug master file entry for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Crexont
A generic version of CREXONT was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28th, 1992.
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Questions you can ask:
- What is the 5 year forecast for CREXONT?
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Summary for CREXONT
| US Patents: | 30 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| Patent Applications: | 55 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CREXONT |
| What excipients (inactive ingredients) are in CREXONT? | CREXONT excipients list |
| DailyMed Link: | CREXONT at DailyMed |
Recent Clinical Trials for CREXONT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Cleveland Clinic | PHASE4 |
| Amneal Pharmaceuticals, LLC | PHASE4 |
| Impax Laboratories, LLC | PHASE4 |
Pharmacology for CREXONT
| Drug Class | Aromatic Amino Acid |
Paragraph IV (Patent) Challenges for CREXONT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CREXONT | Extended-release Capsules | carbidopa; levodopa | 35 mg/140 mg 52.5 mg/210 mg 70 mg/280 mg 87.5 mg/350 mg | 217186 | 1 | 2024-09-23 |
US Patents and Regulatory Information for CREXONT
CREXONT is protected by sixty-two US patents and one FDA Regulatory Exclusivity.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-002 | Aug 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-004 | Aug 7, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-001 | Aug 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-003 | Aug 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-002 | Aug 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-003 | Aug 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Impax | CREXONT | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 217186-001 | Aug 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ 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 CREXONT
See the table below for patents covering CREXONT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014332024 | ⤷ Start Trial | |
| Australia | 2019284060 | ⤷ Start Trial | |
| Australia | 2021282393 | ⤷ Start Trial | |
| Canada | 2926082 | ⤷ Start Trial | |
| China | 105658211 | ⤷ Start Trial | |
| Denmark | 3782614 | ⤷ Start Trial | |
| European Patent Office | 3054929 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CREXONT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3209302 | 2390502-9 | Sweden | ⤷ Start Trial | PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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