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 Merz Pharms Gmbh and is included in one NDA.
The generic ingredient in AMPYRA is dalfampridine. There are ten drug master file entries for this compound. Nine 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.
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Questions you can ask:
- What is the 5 year forecast for AMPYRA?
- What are the global sales for AMPYRA?
- What is Average Wholesale Price for AMPYRA?
Summary for AMPYRA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 163 |
Clinical Trials: | 21 |
Patent Applications: | 3,329 |
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 |
---|---|
MGH Institute of Health Professions | Phase 4 |
Milton S. Hershey Medical Center | Phase 2/Phase 3 |
Weill Medical College of Cornell University | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merz Pharms Gmbh | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
---|---|---|---|---|---|---|---|
Merz Pharms Gmbh | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Merz Pharms Gmbh | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>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 | 0484186 | Formulations et leur utilisation dans le traitement de maladies neurologiques (Formulations and their use in the treatment of neurological diseases) | ⤷ Sign Up |
Austria | E511841 | ⤷ Sign Up | |
Poland | 1732548 | ⤷ Sign Up | |
Cyprus | 1114073 | ⤷ Sign Up | |
Ireland | 903952 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMPYRA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1732548 | C20120002 00051 | Estonia | ⤷ Sign Up | PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011 |
2377536 | 92275 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720 |
1732548 | PA2012001,C1732548 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 |
2377536 | PA2013015,C2377536 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 |
0484186 | C300503 | Netherlands | ⤷ Sign Up | PRODUCT NAME: 4-AMINOPYRIDINE EN DERIVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |