noxafil Drug Patent Profile
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When do Noxafil patents expire, and what generic alternatives are available?
Noxafil is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co. and is included in four NDAs. There are six patents protecting this drug and three Paragraph IV challenges.
This drug has seventy-eight patent family members in twenty-four countries.
The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Noxafil
A generic version of noxafil was approved as posaconazole by SINOTHERAPEUTICS INC on August 21st, 2019.
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Summary for noxafil
| International Patents: | 78 |
| US Patents: | 6 |
| Applicants: | 3 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 24 |
| Patent Applications: | 1,641 |
| Drug Prices: | Drug price information for noxafil |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for noxafil |
| What excipients (inactive ingredients) are in noxafil? | noxafil excipients list |
| DailyMed Link: | noxafil at DailyMed |
Recent Clinical Trials for noxafil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Milton S. Hershey Medical Center | Early Phase 1 |
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| Cidara Therapeutics Inc. | Phase 3 |
Pharmacology for noxafil
| Drug Class | Azole Antifungal |
Paragraph IV (Patent) Challenges for NOXAFIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NOXAFIL | Injection | posaconazole | 18 mg/mL, 16.7 mL vials | 205596 | 1 | 2015-11-24 |
| NOXAFIL | Delayed-release Tablets | posaconazole | 100 mg | 205053 | 1 | 2014-06-16 |
| NOXAFIL | Oral Suspension | posaconazole | 40 mg/mL | 022003 | 1 | 2011-02-28 |
US Patents and Regulatory Information for noxafil
noxafil is protected by nine US patents and three FDA Regulatory Exclusivities.
Patents protecting noxafil
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
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Sulfoalkyl ether cyclodextrin compositions
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Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patent Expiration: ⤷ Sign Up
Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED
Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED
Alkylated cyclodextrin compositions and processes for preparing and using the same
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Sulfoalkyl ether cyclodextrin compositions
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FDA Regulatory Exclusivity protecting noxafil
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
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FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Merck Sharp Dohme | NOXAFIL | posaconazole | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck Sharp Dohme | NOXAFIL | posaconazole | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 noxafil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | NOXAFIL | posaconazole | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | NOXAFIL | posaconazole | TABLET, DELAYED RELEASE;ORAL | 205053-001 | Nov 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Schering | NOXAFIL | posaconazole | SUSPENSION;ORAL | 022003-001 | Sep 15, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | NOXAFIL | posaconazole | SOLUTION;INTRAVENOUS | 205596-001 | Mar 13, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for noxafil
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp and Dohme B.V | Noxafil | posaconazole | EMEA/H/C/000610 Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. |
Authorised | no | no | no | 2005-10-25 | |
| Accord Healthcare S.L.U. | Posaconazole AHCL | posaconazole | EMEA/H/C/005028 Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. |
Authorised | yes | no | no | 2019-07-25 | |
| Accord Healthcare S.L.U. | Posaconazole Accord | posaconazole | EMEA/H/C/005005 Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis;Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. |
Authorised | yes | no | no | 2019-07-25 | |
| Schering-Plough Europe | Posaconazole SP | posaconazole | EMEA/H/C/000611 Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who areat high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. |
Withdrawn | no | no | no | 2005-10-25 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for noxafil
See the table below for patents covering noxafil around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013130666 | ⤷ Sign Up | |
| South Korea | 101834024 | ⤷ Sign Up | |
| Denmark | 3391890 | ⤷ Sign Up | |
| Hungary | 0400856 | ⤷ Sign Up | |
| South Korea | 20130114603 | POSACONAZOLE INTRAVENOUS SOLUTION FORMULATIONS STABILIZED BY SUBSTITUTED BETA-CYCLODEXTRIN | ⤷ Sign Up |
| China | 105288650 | Sulfoalkyl ether cyclodextrin compositions | ⤷ Sign Up |
| Hungary | T75879 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for noxafil
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0736030 | C300219 | Netherlands | ⤷ Sign Up | PRODUCT NAME: POSACONAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER EN/OF ZOUT; REGISTRATION NO/DATE: EU/1/05/320/001EU/1/05/321/001 2005251025 |
| 0736030 | SPC/GB06/007 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: POSACONAZOLE, OPTIONALLY IN THE FORM OF AN ESTER OR PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/05/320/001 20051025; UK EU/1/05/321/001 20051025 |
| 0736030 | 8/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: POSACONAZOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/05/320/001 EU/1/05/321/001 20051025 |
| 0736030 | CA 2006 00002 | Denmark | ⤷ Sign Up | |
| 0736030 | 300219 | Netherlands | ⤷ Sign Up | 300219, 20141220, EXPIRES: 20191219 |
| 0736030 | SPC003/2006 | Ireland | ⤷ Sign Up | SPC003/2006: 20061023, EXPIRES: 20191219 |
| 0736030 | 91216 | Luxembourg | ⤷ Sign Up | 91216, EXPIRES: 20191220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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