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: patents@pharmexcil.com, info@pharmexcil.com

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