Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Home Drug Databases Orange Book Home
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`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
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`Additional Information about Patents
`
`Patent information is published on or after the submission date as defined in 21
`CFR 314.53(d)(5).
`Patent listings published prior to August 18, 2003, only identify method-of-use
`claims. The listed patents may include drug substance and/or drug product
`claims that are not indicated in the listing.
`As of December 5, 2016, an NDA holder submitting information on a patent that
`claims both the drug substance and the drug product (and is eligible for listing
`on either basis) is required only to specify that it claims either the drug
`substance or the drug product. Orange Book users should not rely on an
`Orange Book patent listing, regardless of when first published, to determine the
`range of patent claims that may be asserted by an NDA holder or patent owner.
`
`Patent and Exclusivity for: N202107
`
`Product 001
`MIFEPRISTONE (KORLYM) TABLET 300MG
`
`Patent Data
`
`DR
`
`Patent
`Use
`Code
`
`U-1643
`
`U-1643
`
`U-1643
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`001
`
`001
`
`001
`
`10006924 08/12/2036
`
`10151763 01/18/2037
`
`10166242 04/20/2036
`
`https://www.accessdata.fda.gov/Scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=202107&Appl_type=N[7/25/2019 10:39:18 AM]
`
`NEPTUNE GENERICS - Ex. 1038
`Page 1
`
`
`
`
`
`
`
`Home Drug Databases Orange Book Home
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
` SHARE TWEET LINKEDIN PIN IT EMAIL PRINT
`
`Home | Back to Product Details
`
`Additional Information about Patents
`
`Patent information is published on or after the submission date as defined in 21
`CFR 314.53(d)(5).
`Patent listings published prior to August 18, 2003, only identify method-of-use
`claims. The listed patents may include drug substance and/or drug product
`claims that are not indicated in the listing.
`As of December 5, 2016, an NDA holder submitting information on a patent that
`claims both the drug substance and the drug product (and is eligible for listing
`on either basis) is required only to specify that it claims either the drug
`substance or the drug product. Orange Book users should not rely on an
`Orange Book patent listing, regardless of when first published, to determine the
`range of patent claims that may be asserted by an NDA holder or patent owner.
`
`Patent and Exclusivity for: N202107
`
`Product 001
`MIFEPRISTONE (KORLYM) TABLET 300MG
`
`Patent Data
`
`DR
`
`Patent
`Use
`Code
`
`U-1643
`
`U-1643
`
`U-1643
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`001
`
`001
`
`001
`
`10006924 08/12/2036
`
`10151763 01/18/2037
`
`10166242 04/20/2036
`
`https://www.accessdata.fda.gov/Scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=202107&Appl_type=N[7/25/2019 10:39:18 AM]
`
`NEPTUNE GENERICS - Ex. 1038
`Page 1
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`10166243 04/20/2036
`
`10195214 06/19/2037
`
`10231983 08/22/2038
`
`10314850 08/22/2038
`
`8921348
`
`08/27/2028
`
`9829495
`
`08/15/2036
`
`9943526
`
`04/20/2036
`
`U-1643
`
`U-1643
`
`U-1643
`
`U-1643
`
`U-1643
`
`U-1643
`
`U-1643
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`ODE-22
`
`
`
`02/17/2019
`
`View a list of all patent use codes
`View a list of all exclusivity codes
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-INFO-FDA (1-888-463-6332)
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`https://www.accessdata.fda.gov/Scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=202107&Appl_type=N[7/25/2019 10:39:18 AM]
`
`NEPTUNE GENERICS - Ex. 1038
`Page 2
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
` Regulatory Information
`
` Training & Continuing Education
`
` Science & Research
`
` Safety
`
` Inspections & Compliance
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` Industry
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`https://www.accessdata.fda.gov/Scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=202107&Appl_type=N[7/25/2019 10:39:18 AM]
`
`NEPTUNE GENERICS - Ex. 1038
`Page 3
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`
`
`
`
`Home Drug Databases Orange Book Home
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
` SHARE TWEET LINKEDIN PIN IT EMAIL PRINT
`
`Home | Back to Search Results
`
`Product Details for NDA 202107
`
`KORLYM (MIFEPRISTONE)
`300MG
`
`Marketing Status: Prescription
`
`Active Ingredient: MIFEPRISTONE
`Proprietary Name: KORLYM
`Dosage Form; Route of Administration: TABLET; ORAL
`Strength: 300MG
`Reference Listed Drug: Yes
`Reference Standard: Yes
`TE Code:
`Application Number: N202107
`Product Number: 001
`Approval Date: Feb 17, 2012
`Applicant Holder Full Name: CORCEPT THERAPEUTICS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | ةيبرعلا | Kreyòl Ayisyen | Français | Polski |
`Português | Italiano | Deutsch | 日本語 | یسراف | English
`
`Accessibility Careers FDA Basics FOIA No FEAR Act Nondiscrimination Website Policies
`
`U.S. Food and Drug Administration
`
`https://www.accessdata.fda.gov/Scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=202107[7/25/2019 10:39:48 AM]
`
`NEPTUNE GENERICS - Ex. 1038
`Page 4
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-INFO-FDA (1-888-463-6332)
`
`Contact FDA
`
`
`
` FDA Archive
`
` Emergency Preparedness
`
` Federal, State & Local Officials
`
` International Programs
`
` Consumers
`
` News & Events
`
` Health Professionals
`
` Combination Products
`
` Advisory Committees
`
`
`
` Regulatory Information
`
` Training & Continuing Education
`
` Science & Research
`
` Safety
`
` Inspections & Compliance
`
` Industry
`
`
`
`https://www.accessdata.fda.gov/Scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=202107[7/25/2019 10:39:48 AM]
`
`NEPTUNE GENERICS - Ex. 1038
`Page 5
`
`
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