Ensifentrine - Generic Drug Details
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What are the generic sources for ensifentrine and what is the scope of freedom to operate?
Ensifentrine
is the generic ingredient in one branded drug marketed by Verona Pharma and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ensifentrine has eighty-eight patent family members in thirty countries.
One supplier is listed for this compound.
Summary for ensifentrine
| International Patents: | 88 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| Patent Applications: | 135 |
| What excipients (inactive ingredients) are in ensifentrine? | ensifentrine excipients list |
| DailyMed Link: | ensifentrine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ensifentrine
Generic Entry Date for ensifentrine*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SUSPENSION;INHALATION |
*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 ensifentrine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nuance Pharma (shanghai) Co., Ltd | Phase 1 |
| Nuance Pharma (shanghai) Co., Ltd | Phase 3 |
| Laboratory Corporation of America | Phase 3 |
US Patents and Regulatory Information for ensifentrine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Verona Pharma | OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389-001 | Jun 26, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Verona Pharma | OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389-001 | Jun 26, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Verona Pharma | OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389-001 | Jun 26, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Verona Pharma | OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389-001 | Jun 26, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 ensifentrine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2603509 | FORME CRYSTALLINE D'UN CONPOSE DE PYRIMIDO[6,1-A] ISOQUINOLIN-4-ON (CRYSTALLINE FORM OF PYRIMIDO[6,1-A] ISOQUINOLIN-4-ONE COMPOUND) | ⤷ Sign Up |
| Japan | 2013533301 | ⤷ Sign Up | |
| Brazil | 112013003087 | forma cristalina de composto de pirimidio[6,1-a]-isoquinolin-4-ona | ⤷ Sign Up |
| Lithuania | 3193835 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
