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SERNIVO Drug Profile

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Which patents cover Sernivo, and when can generic versions of Sernivo launch?

Sernivo is a drug marketed by Encore Dermat and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in SERNIVO is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

US ANDA Litigation and Generic Entry Outlook for Sernivo

A generic version of SERNIVO was approved as betamethasone dipropionate by FOUGERA PHARMS on January 25^th, 2020.

Summary for SERNIVO

International Patents:	7
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	39
Patent Applications:	2,506
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SERNIVO
Drug Sales Revenues:	Drug sales revenues for SERNIVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SERNIVO
DailyMed Link:	SERNIVO at DailyMed

See drug prices for SERNIVO

See drug sales revenues for SERNIVO

Recent Litigation for SERNIVO

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Promius Pharma LLC v. Perrigo UK FINCO Limited Partnership	2018-05-22

See all SERNIVO litigation

Pharmacology for SERNIVO

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Synonyms for SERNIVO

(11-beta,16-beta)-9-Chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione

(11.beta.,16.beta.)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

(11beta,16beta)-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate

(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-(propionyloxy)acetyl)-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthr

[2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] propanoate

[2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate

2-((2S,10S,11S,13S,15S,17S,1R,14R)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxo -14-propanoyloxytetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-o xoethyl propanoate

5593-20-4

826Y60901U

9-Fluoro-11.beta.-hydroxy-16.beta.-methyl-3,20-dioxo-17-(propionyloxy)pregna-1,4-dien-21-yl propionate #

9-Fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate

9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-di(propionate)

9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate

9alpha-Fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17,21-Dipropionate

AB01274713_02

AB01274713-01

AB2000220

AC1L2J44

AKOS015969733

Alphatrex

AN-14216

B3166

BDBM50421892

Beloderm

beta-Methasone 17,21-dipropionate

Betamethasone 17,21-dipropionate

BETAMETHASONE DIPROP

betamethasone dipropionat

BETAMETHASONE DIPROPIONATE

Betamethasone Dipropionate (Diprolene)

Betamethasone dipropionate (JP17/USP)

Betamethasone dipropionate [USAN:BAN:JAN]

Betamethasone dipropionate [USAN:USP:JAN]

betamethasone propionate

Betamethasone-17,21-dipropionate

BRD-K58148589-001-03-6

BRN 3638108

C-22966

C28H37FO7

CAS-5593-20-4

CC-24614

CHEBI:31276

CHEMBL1200384

CIWBQSYVNNPZIQ-XYWKZLDCSA-N

component of Alphatrex (Salt/Mix)

component of Betasone (Salt/Mix)

CS-7549

D01637

Diproderm

Diprolene

Diprolene AF

Diprosis

Diprosone

Diprospan;Diprolene;Diprosone;Diprolene AF;Diprolene

DSSTox_CID_2672

DSSTox_GSID_22672

DSSTox_RID_76683

DTXSID2022672

EBD2157850

EINECS 227-005-2

en-17-yl propionate

HY-13571

KS-5303

LS-118474

Maxivate

MolPort-002-515-791

NCGC00159360-02

NCGC00159443-01

NCGC00159443-02

Pregna-1,4-diene-3,20-dione, 9-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methyl-,17,21-dipropionate

Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 17,21-dipropionate

Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-,17,21-dipropionate

Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)-

Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)

Psorion

Rinderon DP

Rinderon-DP (TN)

S 3440

S-3440

s1688

Sch 11460

Sch-11460

SCHEMBL7519

Sernivo (TN)

ST024761

Tox21_113343

UNII-826Y60901U

ZINC4212137

Paragraph IV (Patent) Challenges for SERNIVO

Tradename	Dosage	Ingredient	NDA	Submissiondate
SERNIVO	SPRAY;TOPICAL	betamethasone dipropionate	208079	2018-02-15

US Patents and Regulatory Information for SERNIVO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Encore Dermat	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Encore Dermat	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Encore Dermat	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Encore Dermat	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes
Encore Dermat	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y
Encore Dermat	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079-001	Feb 5, 2016		RX	Yes	Yes			Y

International Patents for SERNIVO

Country	Patent Number	Estimated Expiration
European Patent Office	3141246
Denmark	2473161
Japan	5833007
European Patent Office	2473161
Spain	2637447
Japan	2013503203