ALISKIREN HEMIFUMARATE Drug Patent Profile
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Which patents cover Aliskiren Hemifumarate, and when can generic versions of Aliskiren Hemifumarate launch?
Aliskiren Hemifumarate is a drug marketed by Endo Operations and is included in one NDA.
The generic ingredient in ALISKIREN HEMIFUMARATE is aliskiren hemifumarate. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aliskiren Hemifumarate
A generic version of ALISKIREN HEMIFUMARATE was approved as aliskiren hemifumarate by ENDO OPERATIONS on March 22nd, 2019.
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Summary for ALISKIREN HEMIFUMARATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Patent Applications: | 100 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALISKIREN HEMIFUMARATE |
| DailyMed Link: | ALISKIREN HEMIFUMARATE at DailyMed |
Pharmacology for ALISKIREN HEMIFUMARATE
| Drug Class | Renin Inhibitor |
| Mechanism of Action | Renin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ALISKIREN HEMIFUMARATE
Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TEKTURNA | Tablets | aliskiren hemifumarate | 150 mg and 300 mg | 021985 | 1 | 2014-01-27 |
US Patents and Regulatory Information for ALISKIREN HEMIFUMARATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | ALISKIREN HEMIFUMARATE | aliskiren hemifumarate | TABLET;ORAL | 206665-001 | Mar 22, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | ALISKIREN HEMIFUMARATE | aliskiren hemifumarate | TABLET;ORAL | 206665-002 | Mar 22, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
