REPEAT-UPDATE 1-Bayer, J&J to submit Xarelto data in Q4 earliest

(Repeats to remove extraneous text)

* Data filing might take until early 2010- Bayer

* FDA has asked for European market surveillance data

* FDA also requested more data on completed, ongoing studies (Adds details, background)

FRANKFURT, July 14 (Reuters) - Bayer BAYG.DE and Johnson & Johnson (JNJ.N) need at least until the fourth quarter to gather data requested by U.S. regulators on their anti-blood-clotting pill Xarelto, the companies said on Tuesday.

In May, the U.S. Food and Drug Administration (FDA) declined to approve Xarelto for its first use in patients temporarily bedridden after hip and knee replacement surgery.[ID:nLR959606]

It had asked for more information in a so-called "complete response letter" but stopped short of demanding new tests on humans.

The drug, based on the active ingredient rivaroxaban, has already been approved in Europe for use after orthopaedic surgery, and the two companies are now pursuing clearance for the potential blockbuster in the United States, the largest market for Xarelto. Bayer said on Tuesday that the FDA has asked for data from countries where Xarelto is already on the market as well as from completed and ongoing trials.

It might take until early 2010 to file a response to the FDA's queries, a Bayer spokeswoman said.

Bayer's shares extended earlier losses, trading down 1.3 percent to 36.72 euros by 1457 GMT. J&J was up 0.7 percent at $58.15.

For Xarelto to reach blockbuster status, meaning it generates more than $1 billion in annual sales, the drugmakers will have to clear even more hurdles.

Bayer and J&J are also targeting the mass market of stroke prevention in patients suffering from atrial fibrillation, a common form of irregular heartbeat. Market launch for that indication is not seen before 2011.

The anticoagulant drug, which Bayer says could eventually generate more than 2 billion euros ($2.80 billion) in annual sales, was backed by an FDA committee in March despite concerns over possible side effects and worries about long-term use.

In its use after orthopaedic surgery, the oral drug is a rival to Sanofi-Aventis' (SASY.PA) injectable treatment Lovenox, a standard treatment based on heparin.

Bristol-Myers Squibb (BMY.N) and Pfizer Inc (PFE.N) are developing a rival drug, as is Boehringer Ingelheim of Germany. (Reporting by Ludwig Burger; Editing by Rupert Winchester)