Details for Patent: 12,622,903
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Which drugs does patent 12,622,903 protect, and when does it expire?
Patent 12,622,903 protects REZENOPY and is included in one NDA.
This patent has four patent family members in four countries.
Summary for Patent: 12,622,903
| Title: | Drug products for intranasal administration and uses thereof |
| Abstract: | Provided herein are drug products adapted for nasal delivery comprising a device and a pharmaceutical composition comprising an opioid receptor antagonist, wherein the claimed invention provides a unit dose of an aqueous pharmaceutical solution, or aqueous pharmaceutical composition, housed in a device configured for intranasal administration to a patient, wherein the aqueous pharmaceutical solution consists of, or the aqueous pharmaceutical composition consists essentially of: (i) naloxone hydrochloride in an amount of about 9% by weight based on the total weight of the aqueous pharmaceutical solution; (ii) glycerin in an amount of about 1.4% by weight based on the total weight of the aqueous pharmaceutical solution; (iii) a citrate buffer system adjusted by hydrochloric acid and/or sodium hydroxide; and (iv) United States Pharmacopeia (USP)-grade Purified Water; wherein the pH of the aqueous pharmaceutical solution is from about 3.5 to about 4.7; and wherein the hydrochloric acid and the sodium hydroxide may each be independently present in the aqueous pharmaceutical solution, as required, to achieve the pH from about 3.5 to about 4.7. |
| Inventor(s): | Gregory G. Plucinski, Adrian T. Raiche, Kristi R. Sims |
| Assignee: | Summit Biosciences Inc |
| Application Number: | US18/602,972 |
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Patent Claim Types: see list of patent claims | Formulation; Compound; Device; |
Drugs Protected by US Patent 12,622,903
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Scienture | REZENOPY | naloxone hydrochloride | SPRAY;NASAL | 215487-001 | Apr 19, 2024 | RX | Yes | Yes | 12,622,903 | ⤷ 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 |
International Family Members for US Patent 12,622,903
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2021217164 | ⤷ Start Trial | |||
| Canada | 3166250 | ⤷ Start Trial | |||
| European Patent Office | 4100012 | ⤷ Start Trial | |||
| World Intellectual Property Organization (WIPO) | 2021158957 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
