San Diego-based Cadence Pharmaceuticals (NASDAQ: CADX) won FDA clearance in November to start selling the first intravenous form of a common pain reliever, and it’s already attracting competition from a generic rival.

The FDA’s website was updated today to show that another company is seeking to sell a generic version of injectable acetaminophen, which Cadence markets under the brand name Ofirmev. The FDA website didn’t disclose the name of the company seeking to bring the generic treatment to the market. Cadence, in a regulatory filing, noted that its drug is covered by two patents. The product in question here is different than the acetaminophen tablets you can find at every corner drugstore, marketed under the name Tylenol.

“We firmly believe in the strength of our patents. We anticipated challenges and are prepared to vigorously defend our intellectual property rights to Ofirmev,” said Cadence CEO Ted Schroeder, in an e-mailed statement.

No doubt, Cadence has good reason to gear up for a legal battle to defend its patents. Its reformulated version of acetaminophen, used in hospitals, is the company’s only product that is currently available for sale on the U.S. market. Cadence has positioned the new drug as an option for hospital-based patients who can’t take oral pain relievers, and as an alternative to opioid-based narcotic pain relievers that can be addictive and cause side effects, like chronic constipation. Cadence has reported strong initial demand from hospitals for the product. The company has said it expects its drug to win a spot on the preferred drug lists of 1,000 to 1,200 hospitals by year’s end, compared with its original forecast of 800 to 1,000 hospitals.

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San Diego’s Somaxon Pharmaceuticals, which overcame setbacks before winning FDA approval for its insomnia drug last year, is now facing some stiff new challenges, according to an interesting story by Keith Darcé of The San Diego Union-Tribune.

As we explained last year, Somaxon already was facing stiff competition from over-the-counter sleeping aids and other generics after the FDA finally approved its application for doxepin, its sleeping pill marketed as Silenor. Now four generic drug-makers are challenging Somaxon’s patents as part of their requests for FDA approval to sell lower-cost generic versions of doxepin.

Somaxon, which declined to comment in the U-T, has filed lawsuits against the generic drugmakers, Par Pharmaceutical of Woodcliff Lake, N.J.; Zydus Pharmaceuticals of Pennington, N.J.; Mylan of Canonsburg, Pa.; and Actavis of Morristown, N.J. The four generic drug companies also declined to comment.

The lawsuits provide a nearly three-year delay in efforts to get the generic drugs to market, but litigation is costly. Stay tuned as this one gets sorted out.

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This week saw a long-awaited FDA approval for a Boston-area drug maker, speculation about a possible buyout of a local biotech giant, and some in-depth profiles on other key life sciences players.

—Hospital software maker Picis, of Wakefield, MA, said it is being acquired by Ingenix, an Eden Prairie, MN-based healthcare intelligence and analytics firm. The companies didn’t disclose financials details of the transaction, but Ingenix said it will maintain Picis’ locations in Wakefield and throughout the U.S. and Europe.

—Cambridge, MA-based Momenta Pharmaceuticals nabbed a long-sought FDA approval for a generic version of the anti-clotting drug it developed with Novartis unit Sandoz. The regulatory approval proves that Momenta (NASDAQ: MNTA) can make equivalents of more complex drug mixtures, which pose a greater challenge for would-be generics makers than do more conventional small-molecule pills, Luke wrote.

—Ryan took a look at RainDance Technologies, a Lexington, MA-based company developing next-generation genomic analysis technology. The startup’s first commercial product is a system that conducts thousands of DNA experiments simultaneously, which has caught the eye of research houses and pharma companies.

—Cambridge-based BioScale has flown relatively under the radar while developing a method of measuring biological samples using sound wave technology, Ryan wrote. But the company has caught the eye of another Cambridge biotech player: Millennium, The Takeda Oncology Company, which is using BioScale’s technology to measure cancer-related proteins for its drug research. The access comes as part of BioScale’s beta release of its technology.

—Following last week’s talk of a potential acquisition of Genzyme by drug giant Sanofi-Aventis, Ryan asked readers to weigh in on how much they thought Cambridge-based Genzyme’s stock would be worth in a buyout. Their answers averaged out to $76.29 per share, for a total value of about $20.4 billion. That’s well above the $70 per share that the Sanofi (NYSE: SNY) board authorized the company to offer for Genzyme (NASDAQ: GENZ).

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Cubist Pharmaceuticals (NASDAQ:CBST) plans to mount a lawsuit against Teva Parenteral Medicines after Teva made known that it plans to seek U.S. approval of a generic version of Cubist’s top-selling antibiotic daptomycin (Cubicin), Cubist announced this morning.

Lexington, MA-based Cubist says that Teva informed the company in a letter that it planned to gain approval of its daptomycin copy before two of Cubist’s patents on the drug expire in September 2019 and June 2016, telling Cubist that the patents are either invalid or not infringed. Cubist now has 45 days from receiving the letter to file a patent infringement lawsuit, which would block the FDA from approving Teva’s version of the drug for 30 months or until a district court rules that Cubist’s patents are invalid or not infringed upon by the Teva drug.

Daptomycin is key to Cubist’s current business. The injectable antibiotic, which is used to treat skin and blood stream infections caused by resistant bugs such as MRSA, brought the company $414.7 million of its $433.6 million in total revenue last year, according to the firm.

News of Teva’s bid to muscle in on Cubist’s daptomycin franchise had a chilling effect on Cubist’s stock price, which fell about 15 percent in pre-market trading from its close of $22.25 per share on Monday.

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Momenta Pharmaceuticals, the Cambridge, MA-based developer of generic versions of complex drugs, said today it has received commitments from investors to bet another $24.1 million on the company. The investors are buying 2.8 million shares at $9 a share. The money will be used for manufacturing, clinical trial costs, and potential acquisitions of companies and technologies, the company said.

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Shares of Cambridge, MA-based Momenta Pharmaceuticals rose more than 11 percent today after the FDA agreed to review an application filed by its partner, Sandoz, to sell a generic version of Copaxone, a billion-dollar drug for multiple sclerosis.

Momenta, (NASDAQ: MNTA) doesn’t have any marketed products of its own. So, naturally, the application to market a generic version of Teva Pharmaceutical Industries’ Copaxone is “one of Momenta’s top priorities,” said CEO Craig Wheeler, in a statement. Copaxone had $1.1 billion in U.S. sales last year, so the first company to come up with a generic version could grab a significant piece of the action.

Momenta’s stock rose 11 percent to $14.57 at 10:56 a.m. Eastern time after the announcement. Teva didn’t take the filing lightly. In a statement, it said its patents are still valid until 2014 and it intends to sue Momenta and Sandoz for patent infringement.

Jerusalem-based Teva, the world’s largest generic drugmaker, is arguing that Copaxone is a complex formulation and would be extremely difficult for anyone to copy. It’s a bit ironic, since that’s the same argument big biotech companies like Amgen and Genentech use to keep generic manufacturers like Teva from moving in on their turf. This could get interesting in the coming months over at FDA.

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