Lefamulin acetate - Generic Drug Details
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What are the generic sources for lefamulin acetate and what is the scope of patent protection?
Lefamulin acetate
is the generic ingredient in one branded drug marketed by Nabriva and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lefamulin acetate has eighty-five patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for lefamulin acetate
International Patents: | 85 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 19 |
Patent Applications: | 4 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lefamulin acetate |
What excipients (inactive ingredients) are in lefamulin acetate? | lefamulin acetate excipients list |
DailyMed Link: | lefamulin acetate at DailyMed |
Pharmacology for lefamulin acetate
Drug Class | Anti-coagulant Calculi Dissolution Agent |
Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
Physiological Effect | Decreased Coagulation Factor Activity |
US Patents and Regulatory Information for lefamulin acetate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for lefamulin acetate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | See Plans and Pricing | See Plans and Pricing |
Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lefamulin acetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5893651 | See Plans and Pricing | |
Japan | 5479114 | See Plans and Pricing | |
Croatia | P20220201 | See Plans and Pricing | |
Malaysia | 148916 | PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lefamulin acetate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2137143 | 2021C/501 | Belgium | See Plans and Pricing | PRODUCT NAME: LEFAMULINE, ZOUTEN EN SOLVATEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728 |
2137143 | 301086 | Netherlands | See Plans and Pricing | PRODUCT NAME: LEFAMULINE, ALSMEDE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1457 20200728 |
2137143 | C20200039 00365 | Estonia | See Plans and Pricing | PRODUCT NAME: LEFAMULIIN;REG NO/DATE: EU/1/20/1457 28.07.2020 |
2137143 | 2090054-4 | Sweden | See Plans and Pricing | PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/20/1457 20200728 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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