Raltegravir potassium - Generic Drug Details
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What are the generic sources for raltegravir potassium and what is the scope of freedom to operate?
Raltegravir potassium
is the generic ingredient in two branded drugs marketed by Msd Sub Merck and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Raltegravir potassium has one hundred and fifty-eight patent family members in forty-six countries.
There are five drug master file entries for raltegravir potassium. Nine suppliers are listed for this compound.
Summary for raltegravir potassium
| International Patents: | 158 |
| US Patents: | 6 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 5 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 5 |
| Patent Applications: | 239 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | raltegravir potassium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for raltegravir potassium
Generic Entry Dates for raltegravir potassium*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;ORAL |
Generic Entry Dates for raltegravir potassium*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, CHEWABLE;ORAL |
Generic Entry Dates for raltegravir potassium*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for raltegravir potassium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. James's Hospital, Ireland | Phase 4 |
| French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) | Phase 1/Phase 2 |
| ANRS, Emerging Infectious Diseases | Phase 1/Phase 2 |
Pharmacology for raltegravir potassium
| Drug Class | Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor |
| Mechanism of Action | HIV Integrase Inhibitors |
Medical Subject Heading (MeSH) Categories for raltegravir potassium
Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ISENTRESS HD | Tablets | raltegravir potassium | 600 mg | 022145 | 1 | 2022-10-21 |
| ISENTRESS HD | Tablets | raltegravir potassium | 400 mg | 022145 | 1 | 2011-10-12 |
US Patents and Regulatory Information for raltegravir potassium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045-001 | Dec 21, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045-002 | Dec 21, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 raltegravir potassium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145-001 | Oct 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145-001 | Oct 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045-001 | Dec 21, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for raltegravir potassium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112012009857 | composições farmacêuticas sólidas contendo um inibidor de integrase | ⤷ Try a Trial |
| Canada | 2777937 | COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT UN INHIBITEUR D'INTEGRASE (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING AN INTEGRASE INHIBITOR) | ⤷ Try a Trial |
| China | 102229605 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for raltegravir potassium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1441735 | C20080001 00016 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801 |
| 1441735 | 20221021 | Netherlands | ⤷ Try a Trial | 20221021, EXPIRES: 20221219 |
| 1441735 | C300340 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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