Why Did Suprax remain patented an extra 12 years?

[McCamy Taylor]

The Suprax drug rep came by recently with some coupons. Since Suprax is older than my son (now 22) I asked "How come Suprax doesn't have a generic yet?"

She just smiled and shrugged her shoulders.

Not a good sign. We have all seen generic drugs go back onto patent only (colchicine for gout) or stay on indefinite name brand only status. Why was Suprax---unique in that it is basically an oral form of third generation cephalosporins which are so good at treating UTIs---still so damn expensive?

Apparently, Wyath's patent in Suprax expired in 2003.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5146a6.htm

In July 2002, Wyeth Pharmaceuticals (Collegeville, Pennsylvania) discontinued manufacturing cefixime (Suprax®) in the United States. In October 2002, the company ceased marketing cefixime tablets (200 mg and 400 mg) because of depletion of company inventory. Wyeth's patent for cefixime expired on November 10, 2002. No other pharmaceutical company manufactures or sells cefixime tablets in the United States. Wyeth will continue to sell cefixime suspension (100 mg/5 ml) until March 31, 2003, or until company inventory is depleted, whichever is sooner.

Cefixime is the only CDC-recommended oral antimicrobial agent to which Neisseria gonorrhoeae has not developed significant resistance (1). Uncomplicated N. gonorrhoeae infections may be treated with single-dose regimens of cefixime 400 mg orally, ceftriaxone 125 mg intramuscularly, or an oral fluoroquinolone (ciprofloxacin 500 mg, levofloxacin 250 mg, or ofloxacin 400 mg). However, fluoroquinolones should not be used for treatment of gonorrhea if the infection was acquired in Asia, the Pacific Islands (including Hawaii), or California because the prevalence of fluoroquinolone-resistant N. gonorrhoeae is high in those areas

It decided to stop making the drug, which the WHO considers an essential antibiotic. What happened next is truly surreal. Lupin Ltd got FDA approval to market the drug exclusively in the US.

http://www.lupinpharmaceuticals.com/newsroom_d.html

Lupin Ltd today announced that the U.S. Food and Drug Administration (USFDA) has approved the company's Abbreviated New Drug Application (ANDA) for Cefixime Suspension 100mg/5ml. Earlier this month, Lupin received approval for its Cefixime Tablet 400 mg ANDA.

Lupin is the first company with an ANDA approval for Cefixime. Cefixime was marketed by Wyeth until March 2003 under the Suprax® brand. Lupin will relaunch the product under the Suprax® trademark that Lupin has licensed on an exclusive basis for the US market. The market size of Suprax in the US was $51 million (MAT Dec 2002).

How could one company get the exclusive patent for a drugs whose patent expired? Why did it take 11 years for the FDA to allow a generic version to be produced and sold in this country?

http://aurobindousa.com/aurobindo-pharma-usa-inc-launches-first-generic-cefixime-for-oral-suspension-o-s-usp/

Dayton, NJ (April 20, 2015)
Aurobindo Pharma Limited has received the first Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (USFDA) for Cefixime for Oral Suspension USP, 100 mg/5 mL and 200 mg/5 mL. Cefixime for O.S. is bioequivalent and, therefore, therapeutically equivalent to the brand Suprax®. Cefixime for O. S. is indicated for the treatment of certain types of bacterial infections. Cefixime for O.S. represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceutical products, and is available immediately.

Lupin has not taken the competition well. Their stocks have gone down in value.

http://articles.economictimes.indiatimes.com/2015-04-17/news/61253424_1_suprax-aurobindo-pharma-earnings-growth

"The earlier-than-expected generic competition for Suprax and Antara has been a negative surprise. LPC may pursue acquisition to scale up the brand business near term. An acquisition may be marginally earnings accretive in the near term. However, we are less certain of considerable value accretion," the report said.

Earlier than expected? Did they expect to own the rights forever?

If someone understands how this happened, please let the rest of us know. I can see no reason why patients have to pay hundreds of dollars for an antibiotic that is over two decades old.

[Mnemosyne]

1. Greed, bribes and payoffs are my best guess. Pitiful, isn't it? nt

[whereisjustice]

2. Did they expect to own the rights forever? - With TPP they will virtually own the rights forever.

[Enthusiast]

3. +1

[silvershadow]

5. +1

[Spitfire of ATJ]

4. I wouldn't be surprised if Aurobino Phama and Lupin Ltd weren't owned by the same people.

[3catwoman3]

6. Our practice has pretty much stopped prescribing it...

...because of both price, and because a lot of pharmacies don't stock it. The pharmacies can special order it, but that delays starting treatment.

[fasttense]

7. It's how capitalism works

Capitalism works best when a corporation, bussiness or person has a monopoly. Without a monopoly they have to collude on prices, territory or wages to make huge profits. So never ending patents provide great little monopolies It's better then those silly free markets and competition.

[Thespian2]

8. Don't be surprised...

the last thing drug manufacturers want is to cure a medical problem...

[Stainless]

9. When it comes to integrity and honesty

Big Pharma is even less trustworthy than bankers and politicians.