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DELSTRIGO Drug Profile
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When do Delstrigo patents expire, and when can generic versions of Delstrigo launch?
Delstrigo is a drug marketed by Msd Merck Co and is included in one NDA. There are three patents protecting this drug.
This drug has seventy-nine patent family members in forty-three countries.
The generic ingredient in DELSTRIGO is doravirine; lamivudine; tenofovir disoproxil fumarate. One supplier is listed for this compound. Additional details are available on the doravirine; lamivudine; tenofovir disoproxil fumarate profile page.
DrugPatentWatch® Generic Entry Outlook for Delstrigo
Delstrigo will be eligible for patent challenges on August 30, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 7, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for DELSTRIGO
International Patents: | 79 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Clinical Trials: | 5 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in DELSTRIGO? | DELSTRIGO excipients list |
DailyMed Link: | DELSTRIGO at DailyMed |

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DELSTRIGO
Generic Entry Date for DELSTRIGO*:
Constraining patent/regulatory exclusivity:
NDA:
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 DELSTRIGO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Canada Inc. | Phase 4 |
University Health Network, Toronto | Phase 4 |
Willem Daniel Francois Venter | Phase 3 |
Pharmacology for DELSTRIGO
US Patents and Regulatory Information for DELSTRIGO
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Msd Merck Co | DELSTRIGO | doravirine; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 210807-001 | Aug 30, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Msd Merck Co | DELSTRIGO | doravirine; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 210807-001 | Aug 30, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Msd Merck Co | DELSTRIGO | doravirine; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 210807-001 | Aug 30, 2018 | RX | Yes | Yes | Start Trial | 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 DELSTRIGO
Country | Patent Number | Estimated Expiration |
---|---|---|
Croatia | P20150427 | Start Trial |
Hungary | E031785 | Start Trial |
Dominican Republic | P2012000256 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DELSTRIGO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2552902 | C201930026 | Spain | Start Trial | PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122 |
2552902 | 19C1024 | France | Start Trial | PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1333 20181126 |
2552902 | 1990025-7 | Sweden | Start Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |