DORAVIRINE - Generic Drug Details
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What are the generic drug sources for doravirine and what is the scope of freedom to operate?
Doravirine
is the generic ingredient in two branded drugs marketed by Msd Merck Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Doravirine has seventy-one patent family members in forty-four countries.
Two suppliers are listed for this compound.
Summary for DORAVIRINE
International Patents: | 71 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 49 |
Patent Applications: | 482 |
Drug Prices: | Drug price trends for DORAVIRINE |
What excipients (inactive ingredients) are in DORAVIRINE? | DORAVIRINE excipients list |
DailyMed Link: | DORAVIRINE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DORAVIRINE
Generic Entry Date for DORAVIRINE*:
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 DORAVIRINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ZonMw: The Netherlands Organisation for Health Research and Development | Phase 4 |
Merck Sharp & Dohme LLC | Phase 4 |
Radboud University Medical Center | Phase 4 |
Pharmacology for DORAVIRINE
Drug Class | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
US Patents and Regulatory Information for DORAVIRINE
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Msd Merck Co | PIFELTRO | doravirine | TABLET;ORAL | 210806-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Msd Merck Co | DELSTRIGO | doravirine; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 210807-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Msd Merck Co | PIFELTRO | doravirine | TABLET;ORAL | 210806-001 | Aug 30, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
EU/EMA Drug Approvals for DORAVIRINE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Merck Sharp & Dohme B.V. | Pifeltro | doravirine | EMEA/H/C/004747 Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class. |
Authorised | no | no | no | 2018-11-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for DORAVIRINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Colombia | 6630126 | Inhibidores no nucleosĂdicos de la transcriptasa inversa | ⤷ Try a Trial |
Mexico | 2012011379 | INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA. (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS.) | ⤷ Try a Trial |
Hungary | S1900021 | ⤷ Try a Trial | |
Georgia, Republic of | P20156368 | NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DORAVIRINE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2924034 | 2019C/005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126 |
2924034 | CR 2019 00024 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126 |
2924034 | 2019018 | Norway | ⤷ Try a Trial | PRODUCT NAME: DORAVIRIN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV I KOMBINASJON MED LAMIVUDIN OG I KOMBINASJON MED TENOFOVIRDISOPROKSIL FUMARAT; REG. NO/DATE: EU/1/18/1333/001-2 20181213 |
2552902 | C02552902/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DORAVIRIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67065 17.12.2019 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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