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-three patent family members in forty-four countries.
Two suppliers are listed for this compound.
Summary for doravirine
International Patents: | 73 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 51 |
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 |
---|---|
Insel Gruppe AG, University Hospital Bern | Phase 4 |
University of Bern | Phase 4 |
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for doravirine
US Patents and Regulatory Information for doravirine
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 |
---|---|---|---|
Chile | 2012002744 | Compuesto inhibidor no nucleosídico de la transcriptasa inversa derivado de 3-(hidrocarbiloxi aromático y alifático opcionalmente sustituido)-1-[(5-oxo-4,5-dihidro-1h-1,2,4-triazol-3-il)metil])-piridin-2(ih)-ona; composición farmacéutica que lo comprende útil en la profilaxis y tratamiento de la infección por vih y sida. | ⤷ Subscribe |
Eurasian Patent Organization | 201290976 | НЕНУКЛЕОЗИДНЫЕ ИНГИБИТОРЫ ОБРАТНОЙ ТРАНСКРИПТАЗЫ | ⤷ Subscribe |
Lithuania | C2924034 | ⤷ Subscribe | |
Lithuania | PA2019507 | ⤷ Subscribe | |
Croatia | P20150427 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for doravirine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2924034 | PA2019507 | Lithuania | ⤷ Subscribe | PRODUCT NAME: DORAVIRINAS ARBA JO DRUSKA, LAMIVUDINAS ARBA JO DRUSKA, TENOFOVIRAS ARBA JO ESTERIS, YPAC DIZOPROKSILO ESTERIS ARBA JO DRUSKA, YPAC FUMARATO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1333 20181122 |
2924034 | 2019018 | Norway | ⤷ Subscribe | 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 |
2924034 | 122019000042 | Germany | ⤷ Subscribe | PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN UND TENOFOVIR-DISOPROXIL-FUMARAT; REGISTRATION NO/DATE: EU/1/18/1333 20181122 |
2924034 | SPC/GB19/024 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL; REGISTERED: UK EU/1/18/1333/001-002 20181122; UK PLGB 5305/0015 20181122 |
2552902 | CR 2019 00025 | Denmark | ⤷ Subscribe | 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 |
Doravirine Market Analysis and Financial Projection Experimental
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