AMPYRA Drug Patent Profile
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When do Ampyra patents expire, and when can generic versions of Ampyra launch?
Ampyra is a drug marketed by Acorda and is included in one NDA.
The generic ingredient in AMPYRA is dalfampridine. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ampyra
A generic version of AMPYRA was approved as dalfampridine by ACTAVIS LABS FL INC on January 23rd, 2017.
Summary for AMPYRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 158 |
| Clinical Trials: | 20 |
| Patent Applications: | 2,119 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AMPYRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMPYRA |
| What excipients (inactive ingredients) are in AMPYRA? | AMPYRA excipients list |
| DailyMed Link: | AMPYRA at DailyMed |
Recent Clinical Trials for AMPYRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Milton S. Hershey Medical Center | Phase 2/Phase 3 |
| Weill Medical College of Cornell University | Phase 1 |
| Hospital for Special Surgery, New York | Phase 1 |
Pharmacology for AMPYRA
| Drug Class | Potassium Channel Blocker |
| Mechanism of Action | Potassium Channel Antagonists |
Paragraph IV (Patent) Challenges for AMPYRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AMPYRA | Extended-release Tablets | dalfampridine | 10 mg | 022250 | 8 | 2014-01-22 |
US Patents and Regulatory Information for AMPYRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 AMPYRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMPYRA
See the table below for patents covering AMPYRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3922248 | PROCÉDÉS D'UTILISATION DE COMPOSITIONS D'AMINOPYRIDINE À LIBÉRATION PROLONGÉE (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS) | ⤷ Try a Trial |
| Poland | 2377536 | ⤷ Try a Trial | |
| European Patent Office | 2377536 | Procédés d'utilisation de compositions d'aminopyridine à libération prolongée (Methods of Using Sustained Release Aminopyridine Compositions) | ⤷ Try a Trial |
| Portugal | 1732548 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMPYRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2377536 | PA2013015 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 |
| 0484186 | 11C0049 | France | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001 20110720 |
| 2377536 | 2013/024 | Ireland | ⤷ Try a Trial | PRODUCT NAME: 4-AMINOPYRIDINE (FAMPRIDINE) OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/11/699/001-EU/1/22/699-002 20110720 |
| 0484186 | CA 2011 00031 | Denmark | ⤷ Try a Trial | |
| >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. 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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