drug master filings (dmfs)€¦ · year wise list pharma product patent expiry viii. list of drug...
TRANSCRIPT
Supported by
Department of PharmaceuticalsMinistry of Chemicals and Fertilizers
Govt., of India
Pharmaceuticals Export Promotion Council of IndiaSet up by Ministry of Commerce & Industry
Govt., of India
NOTE ON
DRUG MASTER FILINGS (DMFs) With USFDA
by Indian Pharmaceutical Companies(Type II-Active)
IPR & REGULATORY CENTREPHARMEXCIL
H.O.: 101, Aditya Trade Centre, Ameerpet, Hyderabad – 500038Tel: 040-23735462/23735466, Fax: 91-40-23735464
Email: [email protected], [email protected]
IPR & Regulatory CentreHyderabad
The activities/services offered by the IPR & Regulatory Centre include
• IPR Advisor- Dr. Gopakumar G. Nair
• Organizing Patent, Regulatory Awareness Programmes in different parts of the country
• Encourage IPRs (Patents) in Pharmaceutical/Health Care sector by suitable incentives
• General information on Pharmaceutical Patents
• Information on Patent status of pharmaceutical products in India and other countries
• Interpretation of patent search information
• Search based intellectual property related technology and prior art search
• Invention mining
• Patentability opinion
• Guidance and opinion of IM launch
• Infringement analysis and opinion
• Freedom to Operate (FTO) opinions
• Monthly analysis of patents granted at Indian Patent Office
• List of drug approvals/market authorizations to various countries
The above services are offered by the IPR & Regulatory Centre at nominal charges to the members of the council depending up on the nature of the query raised by the members. Pharmexcil request s all the members to utilize the services effectively.
List of Data Available with IPR & Regulatory Centrei. ListofDrugProductsApprovedbyUSFDA
ii. ListofInactiveIngredientsApprovedbyUSFDA
iii. ListofmanufacturingsitesregisteredasUSFDA
iv. Listofgenericsregisteredatanvisabrazil
v. Year wise list of patent expiry of drug products approved byUSFDA
vi. YearwiselistofmarketexclusivityexpiryofdrugproductsapprovedbyUSFDA
vii. Yearwiselistpharmaproductpatentexpiry
viii.ListofDrugMasterFilingsatUSFDA
ix. ListofmarketauthorizationsatUKMHRA
x. ListofcompaniesinspectedbyUSFDA
xi. List of all drugs available as small molecules, biotech,Nutraceuticals
xii. ListofInternationalNonProprietaryNames
Databases available for members at Pharmexcili. DialogProPatentDatabase
ii. OrbitPatentDatabase
iii. Non-patentliteraturedatabase
Recent Research Papers in journals (Published/In press/ Underreview)
i. GlobalPharmaceuticalTradeandContributionofIndia,ThePharmaReview
ii. Dynamics of Drug Master Filings at USFDA,The Pharma Review(currentissue)
iii. CurrentStatusofPharmaceuticalPatentingofIndia(inpress)
iv. KnowledgeResources-A leadtoPharmaceutical IndustryGrowth(inpress)
v. DynamicsofPharmaceuticalPatentingatUSPTO(underreview)
Books Recently Published by Pharmexcil
i. Note on – Inactive ingredients approved by USFDA for variousdrugformulations(fordifferentdosageformswithspecifiedrouteofadministration)
ii. Indian Biopharmaceutical Industry & Incentives to Exporters ofPharmaceuticals,Biological,BiopharmaandBioservicesectors