lisinopril - Profile
What are the generic sources for lisinopril and what is the scope of freedom to operate?
Lisinopril
is the generic ingredient in four branded drugs marketed by Annora Pharma, Azurity, Accord Hlthcare, Aurobindo, Chartwell Rx, Heritage, Heritage Pharma, Hikma, Invagen Pharms, Lupin, Prinston Inc, Rising, Sciegen Pharms, Strides Pharma, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt Bio Ag, Merck, and Twi Pharms, and is included in twenty-three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Summary for lisinopril
| International Patents: | 10 |
| US Patents: | 12 |
| Tradenames: | 4 |
| Applicants: | 20 |
| NDAs: | 22 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lisinopril |
Paragraph IV (Patent) Challenges for LISINOPRIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| QBRELIS | Oral Solution | lisinopril | 1 mg/mL | 208401 | 1 | 2019-10-24 |
US Patents and Regulatory Information for lisinopril
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Annora Pharma | LISINOPRIL | lisinopril | SOLUTION;ORAL | 218419-001 | Aug 20, 2026 | AA | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Azurity | QBRELIS | lisinopril | SOLUTION;ORAL | 208401-001 | Jul 29, 2016 | AA | RX | Yes | Yes | 9,616,096 | ⤷ Start Trial | ⤷ Start Trial | |||
| Azurity | QBRELIS | lisinopril | SOLUTION;ORAL | 208401-001 | Jul 29, 2016 | AA | RX | Yes | Yes | 10,039,800 | ⤷ Start Trial | ⤷ Start Trial | |||
| Azurity | QBRELIS | lisinopril | SOLUTION;ORAL | 208401-001 | Jul 29, 2016 | AA | RX | Yes | Yes | 10,406,199 | ⤷ Start Trial | ⤷ Start Trial | |||
| Azurity | QBRELIS | lisinopril | SOLUTION;ORAL | 208401-001 | Jul 29, 2016 | AA | RX | Yes | Yes | 12,433,931 | ⤷ Start Trial | ⤷ Start Trial | |||
| Azurity | QBRELIS | lisinopril | SOLUTION;ORAL | 208401-001 | Jul 29, 2016 | AA | RX | Yes | Yes | 10,265,370 | ⤷ 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. | >Exclusivity Expiration |
International Patents for lisinopril
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 3003274 | FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS) | ⤷ Start Trial |
| China | 108472252 | 赖诺普利制剂 (LISINOPRIL FORMULATIONS) | ⤷ Start Trial |
| China | 112972370 | 赖诺普利制剂 (LISINOPRIL FORMULATIONS) | ⤷ Start Trial |
| European Patent Office | 3368012 | FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS) | ⤷ Start Trial |
| European Patent Office | 3960156 | FORMULATIONS DE LISINOPRIL (LISINOPRIL FORMULATIONS) | ⤷ Start Trial |
| Spain | 2886869 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
