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VAGIFEM

NDA

ESTRADIOL | N020908 | NOVO NORDISK INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
NOVO NORDISK INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LIMITED et al 3:2015cv01287 1 patentANDA 208063estradiol	D.N.J.	2015-02-12	Terminated 2015-07-09	—
NOVO NORDISK INC. et al v. TEVA PHARMACEUTICALS USA, INC. 3:2014cv04248 2 patentsANDA 206388estradiol	D.N.J.	2014-07-03	Terminated 2015-05-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Vagifem (2023)

Total Spending

$3.3M

Total Claims

7,961

Beneficiaries

2,346

Avg Cost/Unit

$21.15

Spending Trend

$6.5M(2019)→$4.9M(2020)→$4.1M(2021)→$3.7M(2022)→$3.3M(2023)

YoY Change:+0.5%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs19 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVESTRADIOL

DMF 38291980

GEDEON RICHTER PLCESTRADIOL USP

DMF 40661981

BAYER AGESTRADIOL

DMF 46841982

KINDEVA DRUG DELIVERY LPESTRADIOL TRANSDERMAL DRUG DELIVERY SYSTEM

DMF 98411992

VALDEPHARMESTRADIOL HEMIHYDRATE

DMF 229722009

VALDEPHARMESTRADIOL BENZOATE

DMF 238362010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDESTRADIOL HEMIHYDRATE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 239422010

LUPIN LTDESTRADIOL HEMIHYDRATE USP

DMF 258162012

SYMBIOTEC PHARMALAB PRIVATE LTDESTRADIOL HEMIHYDRATE USP

DMF 341472019

ASPEN OSS BVESTRADIOL 3-ACETATE

DMF 347382020

SCHERING AGInactiveESTRADIOL ENANTHATE

DMF 10931967

ORTHO PHARMACEUTICAL CORPInactiveESTRADIOL 17-A-IN PROPYLENE GLYCOL : PARENTERAL

DMF 16551971

ROUSSEL CORPInactiveESTRADIOL BENZOATE

DMF 22911974

ORGANON INCInactiveESTRADIOL

DMF 26771976

MITSUBISHI CHEMICAL INDUSTRIES LTDInactiveESTRADIOL

DMF 31751978

DIOSYNTH BVInactiveESTRADIOL BENZOATE

DMF 35801979

MEDIMPEX NORTHAMERICA INCInactiveESTRADIOL DIPROPIONATE

DMF 40731981

DIOSYNTH BVInactiveESTRADIOL VALERATE MICRO

DMF 42671981

ROUSSELL UCLAFInactiveESTRADIOL USP

DMF 56861985

DR REDDYS LABORATORIES LTDInactiveESTRADIOL

DMF 69461987

ROUSSELL UCLAFInactiveESTRADIOL

DMF 88191990

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveESTRADIOL

DMF 105361993

CYGNUS INCInactiveESTRADIOL TRANSDERMAL DELIVERY SYSTEM (E2 III TDS)

DMF 106511993

NV ORGANONInactiveESTRADIOL BENZOATE

DMF 150852000

DIOSYNTH BVInactiveESTRADIOL GLUCOSIDE

DMF 157592001

MILLICENT HOLDINGS LTDInactiveESTRADIOL 3 ACETATE

DMF 161202002

CATALENT PHARMA SOLUTIONS LLCInactiveESTRADIOL VAGINAL SOFT GELATIN CAPSULES

DMF 228432009

BEIJING KEYIFENG BIOTECH DEVELOPMENT CO LTDInactiveESTRADIOL USP, NON-STERILE, BULK DRUG

DMF 240852010

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTDInactiveESTRADIOL

DMF 241922010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -30	View Letter (PDF)
Dec 5, 2023	SUPPL -29	View Letter (PDF)
Sep 30, 2022	SUPPL -27	View Letter (PDF)
Apr 10, 2019	SUPPL -26	View Letter (PDF)
Mar 3, 2017	SUPPL -24	View Letter (PDF)
Apr 13, 2012	SUPPL -17	View Letter (PDF)
May 19, 2011	SUPPL -16	View Letter (PDF)
Mar 26, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;VAGINAL | Approved: Mar 26, 1999

No patent or exclusivity listings for this strength.

#002 — 10MCG

RLDAB

0 patents0 exclusivities▾

TABLET;VAGINAL | Approved: Nov 25, 2009