Details for Patent: 8,367,734
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Which drugs does patent 8,367,734 protect, and when does it expire?
Patent 8,367,734 protects PRIMATENE MIST and is included in one NDA.
Summary for Patent: 8,367,734
| Title: | Stable epinephrine suspension formulation with high inhalation delivery efficiency |
| Abstract: | A stable suspension aerosol formulation of epinephrine is suitable for administration through inhalation comprising a therapeutically effective amount of epinephrine, hydrofluorocarbon propellant, co-solvent, surfactant, and antioxidant. The suspension aerosol formulation further comprises [pre-] pre-micronized epinephrine suspended in an alcohol/surfactant solution with hydrofluoroalkane propellant. The suspension formulation provides a highly efficient delivery of drug microparticles into the respirable region of patients' lungs and has the following advantages: lower dosage requirement, minimum alcohol content, with less impurities generated during storage, improved efficacy and safety, and exhibits no ozone depleting potential compared to a formulation containing chlorofluorocarbon. |
| Inventor(s): | Jianxin Gao, James Luo, Rong Zhou, Mary Ziping Luo, Jack Yongfeng Zhang |
| Assignee: | Amphastar Pharmaceuticals Inc |
| Application Number: | US12/776,338 |
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Patent Claim Types: see list of patent claims | Formulation; Compound; Delivery; Dosage form; |
| Patent landscape, scope, and claims: |
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Drugs Protected by US Patent 8,367,734
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Armstrong Pharms | PRIMATENE MIST | epinephrine | AEROSOL, METERED;INHALATION | 205920-001 | Nov 7, 2018 | OTC | Yes | Yes | 8,367,734 | ⤷ Start Trial | Y | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
