Viewing data from:

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

ANDA

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | A212689 | ZYDUS PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: TRUVADA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GILEAD SCIENCES, INC. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 3:2019cv00529 6 patentsANDA 212689emtricitabine and tenofovir disoproxil fumarate	D.N.J.	2019-01-15	Terminated 2019-08-28	—

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 200MG;300MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 28, 2020

No patent or exclusivity listings for this strength.

#002 — 100MG;150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 1, 2021

#003 — 133MG;200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 1, 2021

#004 — 167MG;250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 1, 2021