Viewing data from:

LENALIDOMIDE

ANDA

LENALIDOMIDE | A211022 | APOTEX INC

6 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: REVLIMID(TE code: AB)

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
CELGENE CORPORATION v. APOTEX INC. 2:2019cv13994 15 patentsANDA 211022lenalidomide	D.N.J.	2019-06-19	Terminated 2021-03-10	—
CELGENE CORPORATION v. APOTEX INC. 2:2019cv06999 3 patentsANDA 211022lenalidomide	D.N.J.	2019-02-26	Terminated 2021-03-10	—
CELGENE CORPORATION v. APOTEX INC. 2:2018cv00461 9 patentsANDA 211022lenalidomide	D.N.J.	2018-01-11	Terminated 2021-03-10	—

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

API Supply Chain24 active DMFs2 inactive

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

MATRIX PHARMACORP PRIVATE LTDLENALIDOMIDE

DMF 234102009

ZYDUS LIFESCIENCES LTDLENALIDOMIDE

DMF 271162013

RELIANCE LIFE SCIENCES PVT LTDLENALIDOMIDE

DMF 279052014

CIPLA LTDLENALIDOMIDE

DMF 296282016

DR REDDYS LABORATORIES LTDLENALIDOMIDE DIMETHYLFORMAMIDE SOLVATE

DMF 296902015

DR REDDYS LABORATORIES LTDLENALIDOMIDE (POVIDONE PREMIX)

DMF 296912015

SUN PHARMACEUTICAL INDUSTRIES LTDLENALIDOMIDE

DMF 315492017

MSN LABORATORIES PRIVATE LTDLENALIDOMIDE

DMF 315902017

CHANGZHOU PHARMACEUTICAL FACTORYLENALIDOMIDE

DMF 318042017

MSN LABORATORIES PRIVATE LTDLENALIDOMIDE [ROUTE CODE LW]

DMF 319602017

HETERO LABS LTDLENALIDOMIDE (FORM-H1)

DMF 322792017

SHILPA PHARMA LIFESCIENCES LTDLENALIDOMIDE

DMF 330842020

ALEMBIC PHARMACEUTICALS LTDLENALIDOMIDE (FORM-H1)

DMF 346502020

SYNTHON BVLENALIDOMIDE

DMF 347242020

BIOCON LTDLENALIDOMIDE

DMF 349562020

KYONGBO PHARMACEUTICAL CO LTDLENALIDOMIDE

DMF 351092021

DR REDDYS LABORATORIES LTDLENALIDOMIDE

DMF 355052020

CIPLA LTDLENALIDOMIDE HEMIHYDRATE

DMF 355562021

SHANDONG ANHONG PHARMACEUTICAL CO LTDLENALIDOMIDE (NON-STERILE API)

DMF 357312021

DEVA HOLDING ASLENALIDOMIDE

DMF 364402021

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDLENALIDOMIDE NON-STERILE DRUG SUBSTANCE

DMF 364582021

VERANOVA LPLENALIDOMIDE

DMF 368102022

APITORIA PHARMA PRIVATE LTDLENALIDOMIDE

DMF 377302022

VALARY LAB LTDLENALIDOMIDE HEMIHYDRATE (FORM-B)

DMF 387602023

MYLAN LABORATORIES LTDInactiveLENALIDOMIDE

DMF 242642010

DR REDDYS LABORATORIES LTDInactiveLENALIDOMIDE

DMF 258722012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 7, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 30, 2022

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 30, 2022

#003 — 15MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 30, 2022

#004 — 25MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 30, 2022

#005 — 2.5MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 7, 2023

#006 — 20MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 7, 2023