Viewing data from:

OTEZLA

NDA

APREMILAST | N205437 | AMGEN INC

3 strengths4 unique patents4 unique exclusivities

Patent Timeline

4 unique patents, 3 exclusivities by expiration date

Active (4)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Aug. 16, 2028

Nov. 29, 2034

Nov. 29, 2034

May. 30, 2034

ODE-248

Jan. 19, 2027

M-299

Jan. 19, 2027

NPP

Jan. 19, 2027

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

5 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AMGEN INC. v. APOTEX INC. 3:2022cv03827 3 patentsANDA 217258apremilast	D.N.J.	2022-06-14	Terminated 2023-01-24	—
AMGEN INC. v. ZYDUS PHARMACEUTICALS (USA) INC. 3:2019cv18806 2 patentsANDA 211859apremilast	D.N.J.	2019-10-08	Terminated 2021-06-14	—
Celgene Corporation v. Aurobindo Pharma Limited et al 1:2018cv01005 9 patentsANDA 211716apremilast	D. Del.	2018-07-06	Terminated 2018-10-04	—
AMGEN INC v. SANDOZ INC. 3:2018cv11026 9 patentsANDA 211658apremilast	D.N.J.	2018-06-26	Terminated 2021-09-28	—
AMGEN INC. v. MANKIND PHARMA LTD. 3:2018cv11081 2 patentsANDA 211734apremilast	D.N.J.	2018-06-26	Terminated 2020-08-06	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET NCT05703685	Phase 1	Recruiting	National Institute of Mental Health (NIMH)	108	2023-06-22 → 2029-04-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Otezla (2023)

Total Spending

$877.0M

Total Claims

178,462

Beneficiaries

26,816

Avg Cost/Unit

$79.73

Spending Trend

$401.0M(2019)→$488.5M(2020)→$582.3M(2021)→$710.1M(2022)→$877.0M(2023)

YoY Change:+8.7%

5yr CAGR:+8.4%

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

API Supply Chain34 active DMFs1 inactive

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

LUPIN MANUFACTURING SOLUTIONS LTDAPREMILAST

DMF 302482016

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST [ROUTE CODE LI]

DMF 303322016

DR REDDYS LABORATORIES LTDAPREMILAST (FORM B)

DMF 307322016

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST (FORM-M)

DMF 308662016

ZAKLADY FARMACEUTYCZNE POLPHARMA SAAPREMILAST

DMF 311412016

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST (AMORPHOUS)

DMF 311592016

RAKS PHARMA PVT LTDAPREMILAST

DMF 311802016

LUPIN MANUFACTURING SOLUTIONS LTDAPREMILAST (FORM M)

DMF 312662017

DR REDDYS LABORATORIES LTDAPREMILAST [AMORPHOUS]

DMF 313562017

MSN LIFE SCIENCES PRIVATE LTDAPREMILAST

DMF 313602017

ALIVUS LIFE SCIENCES LTDAPREMILAST

DMF 314902017

LEK PHARMACEUTICALS DDAPREMILAST

DMF 318092017

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAPREMILAST

DMF 318822017

CIPLA LTDAPREMILAST

DMF 320032017

SCINOPHARM TAIWAN LTDAPREMILAST

DMF 320582017

ALKEM LABORATORIES LTDAPREMILAST

DMF 321142017

QUIMICA SINTETICA SAAPREMILAST

DMF 321192017

APITORIA PHARMA PRIVATE LTDAPREMILAST

DMF 321262017

MACLEODS PHARMACEUTICALS LTDAPREMILAST

DMF 321492017

MATRIX PHARMACORP PRIVATE LTDAPREMILAST (CRYSTALLINE)

DMF 321502017

ALEMBIC PHARMACEUTICALS LTDAPREMILAST

DMF 321772017

ZYDUS LIFESCIENCES LTDAPREMILAST

DMF 322232017

HETERO DRUGS LTDAPREMILAST (FORM-B)

DMF 322362017

UNICHEM LABORATORIES LTDAPREMILAST

DMF 323732017

SUN PHARMACEUTICAL INDUSTRIES LTDAPREMILAST

DMF 324732018

NEULAND LABORATORIES LTDAPREMILAST

DMF 329532018

ALEMBIC PHARMACEUTICALS LTDAPREMILAST (FORM-B)

DMF 336552019

RUYUAN HEC PHARM CO LTDAPREMILAST NON-STERILE BULK DRUG SUBSTANCE

DMF 340882019

JUBILANT PHARMOVA LTDAPREMILAST

DMF 344472020

QUIMICA SINTETICA SAAPREMILAST (PROCESS II)

DMF 349152020

CHANGZHOU PHARMACEUTICAL FACTORYAPREMILAST

DMF 378822022

ANHUI POLY PHARM CO LTDAPREMILAST

DMF 384372023

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDAPREMILAST

DMF 391012023

MEGAFINE PHARMA P LTDAPREMILAST (NON-STERILE DRUG SUBSTANCE)

DMF 408342024

INTAS PHARMACEUTICALS LTDInactiveAPREMILAST (AMORPHOUS)

DMF 321792017

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	SUPPL -16	View Letter (PDF)
Jul 25, 2025	SUPPL -14	View Letter (PDF)
Apr 26, 2024	SUPPL -13	View Letter (PDF)
Jul 21, 2023	SUPPL -12	View Letter (PDF)
Dec 21, 2021	SUPPL -11	View Letter (PDF)
Apr 13, 2020	SUPPL -8	View Letter (PDF)
Jul 22, 2019	SUPPL -7	View Letter (PDF)
Jul 5, 2017	SUPPL -6	View Letter (PDF)
Dec 22, 2015	SUPPL -5	View Letter (PDF)
Mar 25, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

RLDAB

4 patents4 exclusivities▴

TABLET;ORAL | Approved: Mar 21, 2014

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7427638	Feb 16, 2028PED: Aug 16, 2028	PED	Yes	Yes	—	—
9872854	May 29, 2034PED: Nov 29, 2034	PED	—	—		—
10092541	May 29, 2034PED: Nov 29, 2034	PED	—	—		—
12576034	Nov 30, 2033PED: May 30, 2034	PED	—	Yes		—

Exclusivities (4)

Code	Date	Status
M-299	Jul 20, 2026	< 1 year
NPP	Apr 25, 2027	< 1 year
ODE-248	Jul 19, 2026	< 1 year
PED	Jan 19, 2027	< 1 year

#002 — 20MG

RLDAB

4 patents4 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 2014

#003 — 30MG

RLDAB

4 patents4 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 2014