Viewing data from:

CENESTIN

NDA

ESTROGENS, CONJUGATED SYNTHETIC A | N020992 | ASPEN PHARMA USA INC

5 strengths0 unique patents0 unique exclusivities

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
TEVA WOMEN'S HEALTH, INC. v. WATSON LABORATORIES, INC. et al 2:2010cv02061 1 patentANDA 091047synthetic conjugated estrogens, A	D.N.J.	2010-04-23	Terminated 2011-10-13	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

11 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 21, 2002

No patent or exclusivity listings for this strength.

#002 — 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 24, 1999

#003 — 0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 24, 1999

#004 — 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 13, 2000

#005 — 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 5, 2004