Trofinetide - Generic Drug Details
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What are the generic drug sources for trofinetide and what is the scope of patent protection?
Trofinetide
is the generic ingredient in one branded drug marketed by Acadia Pharms Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Trofinetide has thirty-six patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for trofinetide
International Patents: | 36 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 26 |
Clinical Trials: | 5 |
Patent Applications: | 45 |
What excipients (inactive ingredients) are in trofinetide? | trofinetide excipients list |
DailyMed Link: | trofinetide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for trofinetide
Generic Entry Date for trofinetide*:
Constraining patent/regulatory exclusivity:
TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER Dosage:
SOLUTION;ORAL |
*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 trofinetide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ACADIA Pharmaceuticals Inc. | Phase 2/Phase 3 |
ACADIA Pharmaceuticals Inc. | Phase 3 |
Neuren Pharmaceuticals Limited | Phase 2 |
US Patents and Regulatory Information for trofinetide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acadia Pharms Inc | DAYBUE | trofinetide | SOLUTION;ORAL | 217026-001 | Mar 10, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acadia Pharms Inc | DAYBUE | trofinetide | SOLUTION;ORAL | 217026-001 | Mar 10, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Acadia Pharms Inc | DAYBUE | trofinetide | SOLUTION;ORAL | 217026-001 | Mar 10, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acadia Pharms Inc | DAYBUE | trofinetide | SOLUTION;ORAL | 217026-001 | Mar 10, 2023 | 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 |
International Patents for trofinetide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20220059479 | 트로피네타이드의 조성물 | ⤷ Try a Trial |
Australia | 2012209466 | Treatment of Autism Spectrum Disorderes using Glycyl-L-2-Methylprolyl-L-Glutamic Acid | ⤷ Try a Trial |
Japan | 6640275 | ⤷ Try a Trial | |
Colombia | 2022002616 | Composiciones de trofinetida | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |