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EVEKEO ODT

NDA

AMPHETAMINE SULFATE | N209905 | AZURITY PHARMACEUTICALS INC

5 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

10441554

Mar. 10, 2037

11160772

Mar. 10, 2037

11896562

Mar. 10, 2037

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 Chain7 active DMFs1 inactive

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

VERANOVA LPAMPHETAMINE SULFATE

DMF 150892000

CAMBREX CHARLES CITY INCAMPHETAMINE SULFATE

DMF 153082001

SPECGX LLCAMPHETAMINE SULFATE

DMF 154252001

CURIA NEW YORK INCAMPHETAMINE SULFATE USP

DMF 160192002

VERANOVA LPAMPHETAMINE SULFATE USP (PROCESS II)

DMF 240482010

SIEGFRIED USA LLCAMPHETAMINE SULFATE

DMF 296012016

CHATTEM CHEMICALS INCAMPHETAMINE SULFATE USP

DMF 332332018

ISP FREETOWN FINE CHEMICALS INCInactiveAMPHETAMINE SULFATE

DMF 156062001

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 16, 2023	SUPPL -4	View Letter (PDF)
Oct 3, 2022	SUPPL -3	View Letter (PDF)
Jun 8, 2022	SUPPL -2	View Letter (PDF)
Apr 19, 2021	SUPPL -1	View Letter (PDF)
Feb 13, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 5MG

RLD

3 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 30, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10441554	Mar 10, 2037	—	—	Yes	—	—
11160772	Mar 10, 2037	—	—	Yes	—	—
11896562	Mar 10, 2037	—	—	—		—

#002 — 10MG

RLD

3 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 30, 2019

#003 — 15MG

RLD

3 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 30, 2019

#004 — 20MG

RLD

3 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 30, 2019

#005 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Apr 16, 2021