AMIFAMPRIDINE PHOSPHATE - Generic Drug Details
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What are the generic sources for amifampridine phosphate and what is the scope of freedom to operate?
Amifampridine phosphate
is the generic ingredient in one branded drug marketed by Catalyst Pharms and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amifampridine phosphate has three patent family members in two countries.
One supplier is listed for this compound.
Summary for AMIFAMPRIDINE PHOSPHATE
| International Patents: | 3 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 18 |
| Clinical Trials: | 8 |
| Patent Applications: | 89 |
| What excipients (inactive ingredients) are in AMIFAMPRIDINE PHOSPHATE? | AMIFAMPRIDINE PHOSPHATE excipients list |
| DailyMed Link: | AMIFAMPRIDINE PHOSPHATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMIFAMPRIDINE PHOSPHATE
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for AMIFAMPRIDINE PHOSPHATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Catalyst Pharmaceuticals, Inc. | Phase 2 |
| Catalyst Pharmaceuticals, Inc. | Phase 3 |
| Catalyst Pharmaceuticals, Inc. |
Pharmacology for AMIFAMPRIDINE PHOSPHATE
| Drug Class | Potassium Channel Blocker |
| Mechanism of Action | Potassium Channel Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for AMIFAMPRIDINE PHOSPHATE
Paragraph IV (Patent) Challenges for AMIFAMPRIDINE PHOSPHATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FIRDAPSE | Tablets | amifampridine phosphate | 10 mg | 208078 | 3 | 2022-11-28 |
US Patents and Regulatory Information for AMIFAMPRIDINE PHOSPHATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Catalyst Pharms | FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Catalyst Pharms | FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Catalyst Pharms | FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Catalyst Pharms | FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Catalyst Pharms | FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Catalyst Pharms | FIRDAPSE | amifampridine phosphate | TABLET;ORAL | 208078-001 | Nov 28, 2018 | 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 |
International Patents for AMIFAMPRIDINE PHOSPHATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2840591 | METHODES D'ADMINISTRATION DE 3,4-DIAMINOPYRIDINE (METHODS OF ADMINISTERING 3,4-DIAMINOPYRIDINE) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2013003708 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2017214504 | ⤷ Sign Up | |
| >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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