DALFAMPRIDINE Drug Patent Profile
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Which patents cover Dalfampridine, and when can generic versions of Dalfampridine launch?
Dalfampridine is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma, Hikma, Micro Labs, Rising, and Sun Pharm. and is included in eight NDAs.
The generic ingredient in DALFAMPRIDINE 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 Dalfampridine
A generic version of DALFAMPRIDINE was approved as dalfampridine by ACTAVIS LABS FL INC on January 23rd, 2017.
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Questions you can ask:
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Summary for DALFAMPRIDINE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 163 |
| Clinical Trials: | 34 |
| Patent Applications: | 2,475 |
| Drug Prices: | Drug price information for DALFAMPRIDINE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DALFAMPRIDINE |
| What excipients (inactive ingredients) are in DALFAMPRIDINE? | DALFAMPRIDINE excipients list |
| DailyMed Link: | DALFAMPRIDINE at DailyMed |
Recent Clinical Trials for DALFAMPRIDINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MGH Institute of Health Professions | Phase 4 |
| European University of Lefke | N/A |
| National Institute of Neurological Disorders and Stroke (NINDS) | Early Phase 1 |
Pharmacology for DALFAMPRIDINE
| Drug Class | Potassium Channel Blocker |
| Mechanism of Action | Potassium Channel Antagonists |
Paragraph IV (Patent) Challenges for DALFAMPRIDINE
| 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 DALFAMPRIDINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 206863-001 | Jul 11, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 206858-001 | Jul 6, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 206811-001 | Jan 23, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 208292-001 | May 21, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Labs Fl Inc | DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 206836-001 | Jan 23, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 206765-001 | Jul 30, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Micro Labs | DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 210158-001 | Mar 11, 2019 | AB | RX | No | No | ⤷ 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 |
