RALTEGRAVIR Drug Patent Profile
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Which patents cover Raltegravir, and what generic alternatives are available?
Raltegravir is a drug marketed by Hetero Labs Ltd Iii and Lupin and is included in two NDAs.
The generic ingredient in RALTEGRAVIR is raltegravir potassium. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Raltegravir
A generic version of RALTEGRAVIR was approved as raltegravir potassium by LUPIN on May 6th, 2025.
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Summary for RALTEGRAVIR
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| DailyMed Link: | RALTEGRAVIR at DailyMed |
US Patents and Regulatory Information for RALTEGRAVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hetero Labs Ltd Iii | RALTEGRAVIR POTASSIUM | raltegravir potassium | TABLET;ORAL | 203540-001 | Dec 19, 2024 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lupin | RALTEGRAVIR POTASSIUM | raltegravir potassium | TABLET;ORAL | 217990-001 | May 6, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |

