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ALKINDI SPRINKLE

NDA

HYDROCORTISONE | N213876 | ETON PHARMACEUTICALS INC

4 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

9649280

May. 12, 2034

9675559

Jan. 10, 2033

9717740

Nov. 19, 2032

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain23 active DMFs21 inactive

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

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCHYDROCORTISONE MICRONIZED AND NON-MICRONIZED

DMF 14131969

EUROAPI FRANCEHYDROCORTISONE USP

DMF 27891976

EUROAPI FRANCEHYDROCORTISONE VALERATE USP BULK SUBSTANCE

DMF 46621982

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCHYDROCORTISONE ACETATE USP, MICRO & NON-MICRO

DMF 54981984

TARO PHARMACEUTICAL INDUSTRIES LTDHYDROCORTISONE 17-VALERATE, USP

DMF 139211998

TARO PHARMACEUTICAL INDUSTRIES LTDHYDROCORTISONE 17-BUTYRATE USP, MICRONIZED

DMF 157502001

HIKMA PHARMACEUTICALSHYDROCORTISONE USP

DMF 160892002

TIANJIN JINJIN PHARMACEUTICAL CO LTDHYDROCORTISONE BASE

DMF 197342006

CURIA SPAIN SAUHYDROCORTISONE BUTYRATE, MICRONIZED

DMF 218412008

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE USP

DMF 280662014

SHANGHAI NEW HUALIAN PHARMACEUTICAL CO LTDHYDROCORTISONE

DMF 285002014

SYMBIOTEC PHARMALAB PRIVATE LTDHYDROCORTISONE HEMISUCCINATE USP

DMF 292212015

EUROAPI FRANCEHYDROCORTISONE

DMF 303732016

SYMBIOTEC PHARMALAB PRIVATE LTDHYDROCORTISONE USP

DMF 313492017

TIANJIN JINJIN PHARMACEUTICAL CO LTDHYDROCORTISONE BASE USP BULK API

DMF 322042017

TIANJIN JINJIN PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE USP BULK API

DMF 322432017

CURIA SPAIN SAUHYDROCORTISONE MICRONIZED

DMF 330022018

SHANDONG XINHUA PHARMACEUTICAL CO LTDHYDROCORTISONE

DMF 330732018

JIANGSU LIANHUAN PHARMACEUTICAL CO LTDHYDROCORTISONE

DMF 360742021

FARMABIOS SPAHYDROCORTISONE HEMISUCCINATE

DMF 376392023

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE M

DMF 379512023

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE M

DMF 382632023

CURIA SPAIN SAUHYDROCORTISONE HEMISUCCINATE MICRONIZED AND NON-MICRONIZED

DMF 388322023

NEW DRUG INSTITUTEInactiveHYDROCORTISONE

DMF 1991940

GIST-BROCADES NV PHARMACEUTICALSInactiveHYDROCORTISONE BULK

DMF 19971972

ANTIBIOTICOS SPAInactiveHYDROCORTISONE 17-VALERATE

DMF 21851972

SCHERING AGInactiveHYDROCORTISONE HEMISUCCINATE

DMF 28891977

SANOFI CHIMIEInactiveHYDROCORTISONE HEMISUCCINATE

DMF 29001977

ANTIBIOTICOS SPAInactiveHYDROCORTISONE 21-HYDROGEN, SUCCINATE, BULK, NON-STERILE

DMF 30971978

DIOSYNTH INCInactiveHYDROCORTISONE MICRONIZED

DMF 39171980

DIOSYNTH BVInactiveHYDROCORTISONE ACETATEMICRO

DMF 39211980

DIOSYNTH BVInactiveHYDROCORTISONE HEMISUCCINATE MICRO

DMF 39611980

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveHYDROCORTISONE 17-VALERATE (THIS DMF FORMERLY HELD BY S.I.R.S)

DMF 39791980

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE BASE & ACETATE

DMF 47101982

BAYER SCHERING PHARMA AGInactiveHYDROCORTISONE

DMF 47571982

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveHYDROCORTISONE HEMISUCCINATE

DMF 61851986

QUATRUMInactiveHYDROCORTISONE HEMISUCCINATE

DMF 66461986

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveHYDROCORTISONE HEMISUCCINATE

DMF 67531986

TIANJIN PHARMACEUTICAL PLANTInactiveHYDROCORTISONE

DMF 82691989

TAISHO PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE BUTEPRATE

DMF 83711989

SHANDONG XINHUA PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE

DMF 116061995

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveHYDROCORTISONE BUTYRATE DRUG SUBSTANCE

DMF 181422005

HENAN LIHUA PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE

DMF 189442005

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE

DMF 321242017

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -5	View Letter (PDF)
Dec 27, 2022	SUPPL -2	View Letter (PDF)
Feb 4, 2022	SUPPL -1	View Letter (PDF)
Sep 30, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.5MG

RLD

3 patents0 exclusivities▴

GRANULE;ORAL | Approved: Sep 29, 2020

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9649280	May 12, 2034	—	—	Yes	—
9675559	Jan 10, 2033	—	—	—	—
9717740	Nov 19, 2032	—	—	—	—

#002 — 1MG

RLD

3 patents0 exclusivities▾

GRANULE;ORAL | Approved: Sep 29, 2020

#003 — 2MG

RLD

3 patents0 exclusivities▾

GRANULE;ORAL | Approved: Sep 29, 2020

#004 — 5MG

RLD

3 patents0 exclusivities▾

GRANULE;ORAL | Approved: Sep 29, 2020