Sun Pharmaceuticals new supplier
 

Our pharmacy was no longer able to get Mylan for our sinemet late last year, and was supplying everyone Activis (sp?)...when I asked, I was told they would be able to get Mylan again early in 2018. Great.

We just filled our script, and lo and behold, it wasn't Mylan, but Sun Pharmaceuticals. I googled Sun and found that they were slapped by the FDA in 2015, I think the issue actually involved levodopa formulations, but even if not, this didn't make us feel very good. What's worse, we read that they acquired some other drug company which also had been fined by the FDA.

I notice that these new pills from Sun Pharma are yellow ovals, like our old sinemet used to be, so I want to hope that they work as they're supposed to. But having read what I have, I'm concerned and wanted to see if anyone here has any experience with carbi/levo made by Sun, thanks!

Lurking,
Sorry I can't help you with Sun, no experience there, but I've used the Actavis 25/100 for quite a while without any problems...

Eric

If I remember correctly 2 generic versions of at least the 25/100 Sinemet are run on the same line. (Actavis makes Sun Pharm. tablets at the same location as they run their tablets.

i have no problem getting the mylan 25/100, 25/250 and the 50/200CR.
i'll check with my pharmacy and find out which wholesaler they use. i haven't tried the activas in awhile but it didn't work as well as the TEVA when i did, haven't compared it to MYLAN.

as an aside, i asked my MDS to write out an RX for the 25/250. i pay for it privately and have refilled it twice, to be used as a reserve in case there is another 25/100 shortage. it's cheap and you sure get a lot of l-dopa. i mix in 1/2 tab (125mg) with my daily 25/100 to extend that supply out.

unbelievable that there are so few generics. TEVA is losing lots of money since buying ALLERGAN and we are being punished since the company they sold their C/L patents to, "MAYNARD"? or something like that is just supplying the activas brand which TEVA used to also own.

good idea, what's the cost?
 

That's a really good idea, ST, to have that extra supply. Do you mind sharing (roughly) how much it costs to buy that 25/250 privately? I realize all pharmacies are different, just trying to get a rough idea, thanks!

Sinemet Prices and Sinemet Coupons - GoodRx

it was less than $20.00 for 90 of the 25/250, for some reason it doesn't cost much more than the 25/100. the actual cost is ridiculously cheap until recently and i was told prices have gone up. i'm lucky that one of my former independent pharmacy customers is still in business and will give me better service because i did so many things for him for free, i installed/wrote the software/and supported over 70 pharmacy customers at one time, just by myself, and had many of the major hospitals as customers. i had to tell my customers i had pd but very few changed to a new system and none because i had pd, noone likes to change computer systems and staying with me was the lesser of 2 evils. about 10 years after diagnosis i had to call it quits, i couldn't in good conscience continue to charge my customers, some i had for over 20 years, to maintain their systems when i couldn't guarantee i could continue to support their systems at least a year into the future, and there was a major software change coming due in how pharmacies bill insurance companies which i just couldn't guarantee i could actually finish the software in time and be certified by dozens of insurance companies, each one having a different certification process and each one giving you a short window of time to test in. My customers would have paid me a lot to keep supporting them, to hire help but i felt that might not have worked, allowing someone to work on a pharmacy's computer requires a lot of trust and if i hired the wrong person and the stole information that would be bad and my customers needed to bite the bullet and get new systems from a large vendor which had lots of features i would have to develop from scratch such as optically storing rx's, signatures, linking drug pictures to rx's, automatic refilling over the internet, blah blah blah. anyway, i still have dreams that i missed the deadline and none of my pharmacy customers could bill their insurance companies and i was in big trouble. a pharmacy has 2 weeks to bill a rx, after that they eat the cost so when that problem occurs alarms go off. nothing worse than having to dispense rx's and hope your software vendor will figure out the billing problem within 2 weeks while you are withholding billing $1000's in RX'S everyday. it's great that all pharmacies use the same billing format but it's quite complicated, there are over 1000 different pieces of data that the insurance company can require your software to send and receive, some in any order so each piece of data is preceded by a unique identifier, and with some data elements you can repeat them many times such as disease codes, allergies, basically when your pharmacy sends a claim to your insurance company, it likely goes to a pharmacy benefits manager's computer, which checks if your rx if covered, not filled too soon at any pharmacy, if there is a drug interaction, a medical condition interaction, an allergy interaction, within acceptable dose ranges for your sex/age, makes even more checks and then the response is sent back to the pharmacy, either accepted or rejected and the reasons why and how much the pharmacy will be paid. the screwiest thing about this system is the pharmacy has to send their true cost in the claim and if it's higher than what the claims manager thinks it should be the claims manager will cut the price to what they will allow. the pharmacy can refuse to fill the rx if the reimbursement is too low. but what can happen is the pharmacy might have entered the wrong cost when they setup the drug and be way low, say $10 when it should be $1000 and the benefits manager will reimburse them $10 + dispensing fee,no questions asked, even though the claims manager knows the hi/low costs for this drug. easy to lose money filling rx's if your're a small pharmay. the pharmacist might not see this error until he gets the remittence from the insurance company listing the payment info on their rx's. so to avoid this potential problem, there are companies that will check the numbers on the claim before it goes to the claim processor and won't send it on to the processor if it finds errors. just adds to healthcare costs. and it takes less than 3 seconds to transmit and receive the response back from the claims processor. so to make a long story short, i'm good friends with this pharmacy's owner but i'm sure you can price shop around and find one that won't gauge you. start with GOOD RX.

Much more complicated than I ever thought!
 

That is a complicated business! But I understand why, of course, and have a new appreciation for our pharmacy.

I'll call in and see how much private pay would be, assuming we could get a script for "emergency backup" meds.

Thanks, ST, a wealth of information, appreciate it:)

Lurking,
Just picked up my 25/100 refill and it is Sun Pharma ovals instead of my Actavis round pills...Notice any difference physically with yours vs Mylan? I will let those interested know if I notice a difference over the next couple of weeks....

Eric

No difference
 

No difference, and the ovals are harder to split. The round ones were scored, which made it easier to split. It'd be nice if patients could get the list of ingredients and % for each generic but I guess that would be like giving out the recipe, and no one wants to do that.

sun
 

My 50/200 CR was filled this month with SUN not my usual. Are people having problems with them? I'm turning into a mess and don't know why. The last week I am having tougher times with my off period. Thought DBS would fix all that but I am still dependent on pills though not as many.

really can't tell:(
 

We are at the point to where we can't really tell if we've taken pills or not-we feel crappy most of the time. This has been going on before our Mylan generic got switched over to Sun, though. The neuro agrees we're undermedicated, and that the therapeutic dose probably needs to increase, but doesn't want to increase because that would put us at 1,000mg/day. Or more. Yikes.

Instead, he's giving us a new script for amantadine. I'm hoping it helps, because no one wants to increase sinemet if they don't absolutely have to.

You may need to shop around to find a different generic if the one you are taking isn't working/working as well as it could be.

according to this site,the mylan 50/200 shortage is over but that doesn't guarantee you can get it. it could mean that your pharmacy can get it but has a supply of the sun product they want to get rid of or their wholesaler is giving them a better price on the SUN so they're using the MYLAN shortage to use as an excuse to make a few more pennies. i'm going to reorder my mylan 50/200 tomorrow and will let you know if i can get it. this wouldn't be a problem if the FDA required that generic mfg's of extended release pills actually forced the mfg to prove their extended release capabilities matched the brand name but they don't.
FDA Drug Shortages

i didn't do well on the other indian brand mentioned, have never tried sun products. the ER versions cost around $40 for 90 tablets if you were to buy a refill privately so you have a backup supply
Carbidopa / Levodopa ER Prices and Carbidopa / Levodopa ER Coupons - GoodRx

sending you a private message

lurkingforacure writes:

"We are at the point to where we can't really tell if we've taken pills or not-we feel crappy most of the time. This has been going on before our Mylan generic got switched over to Sun, though. The neuro agrees we're undermedicated, and that the therapeutic dose probably needs to increase, but doesn't want to increase because that would put us at 1,000mg/day. Or more. Yikes."

A number of issues are raised here.

1. The maximum dose of levodopa.
See the thread "Max Sinemet Dosage????", ashleyk, June 2015
https://www.neurotalk.org/parkinson-...+dose+levodopa
For the reasons explained there, I see no reason for an arbitrary limit of 1000mg/day of levodopa: for some PwP it will be too much, while for others they could benefit from more.

2. The maximum dose of carbidopa.
Brod et al. write[1]:
"Recommended doses of carbidopa are 75–200 mg/day. Higher doses could inhibit brain aromatic amino acid decarboxylase and reduce clinical effects."
However, their work shows:
"Doses of 450 mg/day of carbidopa did not reduce the responses to levodopa infusion, extending the safe range of carbidopa to 450 mg/day."
So, with a normal ratio of 4:1 levodopa:carbidopa this would indicate a maximum of 1800mg/day of levodopa. An alternative option is to take some of the levodopa dose in the 10:1 formulation.

3. The efficacy of generics.
Generics must satisfy bioequivalence rules. These are based on the pharmacokinetic parameters CMAX (maximum concentration) and AUC (area under the curve) [2]:
"The FDA considers two products bioequivalent if the 90% CI of the relative mean Cmax, AUC(0–t) and AUC(0–∞) of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80% to 125% in the fasting state."
This is complicated. It is couched in probabalistic terms. I make a very rough estimate that this means that it is OK, as far as the regulators are concerned, for variations of up to 5% by weight of the active component to be acceptable. This variation is noticeable by PwP. They would notice that they went "off" sooner than usual or that they never crossed the "on" threshold.

References

[1] "Are high doses of carbidopa a concern? A randomized clinical trial in Parkinson’s disease"
Lissa S. Brod, MD,1,2 Jason L. Aldred, MD,1,2 and John G. Nutt, MD1,
Mov Disord, Apr 2012
Are high doses of carbidopa a concern? A randomized clinical trial in Parkinson’s disease

[2] Bioequivalence - Wikipedia

John

JOHN, i haven't looked at this for awhile but generic mfgs don't have to test their drugs on pd'ers, i believe they test only on non-pd'ers' for blood levels. i can understand the reasoning there. and up until recently there has been no testing required for a generic ER (extended release) version to have a similar drug release pattern, i.e., in a healthy patient, what is the half-life and they don't have to prove that it's as long as the brand name. you can assume that the generic mfg would want to be close to the brand name's ER characteristics but i doubt there are that many patients taking brand name sinemet to notice a difference because insurance companies won't readily pay the higher cost. and to totally upset the apple cart, the original mfg of sinemet is squibb who prior to 2012 paid MERCK to make sinemet and MERCK contracts with mylan to make the drug, check the SINEMET insert, there's a picture of the tiny picture on every SINEMET label saying MFG'ED BY MYLAN. So in this case, i'm not sure what numbers the FDA uses to determine if a new generic sinemet's l-dopa peak concentration is ok, i assume MERCK, since i assume that the generic testing involves testing the current brand name, not just using +30 year old numbers from squibb. i'm not criticizing the MYLAN brand, i like it. i liked teva better but they sold off their generic rights along with their rights to the ACTAVIS brand to MAYNE when they bought ALLERGAN which ownd the indian mfg ACTAVIS. The end result is no more TEVA c/l and MAYNE is now selling the C/L made by ACTAVIS and possibly SUN is selling the ACTAVIS manufactured product?

i've noticed differences with some generics, primarily i just feel sick when taking it and/or less relief, i blame feeling sick on dyes, fillers and possible contaminants plus the extra stuff they add to the ER variations to slowly break down and release little chunks of tablet which extends it's lifetime. i assume the reason C/L ER releases C/L for a longer time period than the IR C/L is for that reason, the longer it is protected from enzymes in the stomach breaking down the l-dopa, the greater chance of more l-dopa getting to the small intestine where it is absorbed. that's why you want to slow your stomach emptying a little when taking C/R, if you speed up emptying by taking CR on an empty stomach more of it will leave the stomach still in the pill form which will pass right by the area of the small intestine where it is absorbed. i have to admit i've never found information on the internet describing exactly how CR C/L works to slow release but my guess sounds pretty good?

this is a complicated subject and i'm no expert. all i can say is try to have a 30 day backup supply, more if possible, of your C/L regardless of whether you think one generic is better than another. disruptions in supply chains are going to become more common with global warming and more raw ingredients bought from other countries, especially china and india and more mfg'i
ng occurring in lesser developed countries. there's just a greater chance of a plant being damaged like what happened to mylan in puerto rico, where the mfg and wholesalers didn't have enough inventory to keep supplying the drug or god forbid, trump puts a tariff on some ingredients used in manufacturing ER (cr) C/L, maybe some rare wax, or a bad batch of drug is manufactured for a myriad of reasons. and manufacturers can make a bad batch of drugs, doesn't happen often so good to have some pills from an older batch to compare against. this ain't no trivial matter, a small difference in strength or with the CR/ER versions poor quality or just more of the addons to make the pill dissolve slowly MIGHT make that generic intolerable imho. i kind of feel like i might be unusually sensitive to differences and my neuro doesn't believe there are major differences so i may just be creating a false alarm. fwiw, here's an interesting marketing paper from merck, i think 2011 date, where they make the argument that name brand is better!! is it just patient perception? i forgot to point out that even though MYLAN mfg's SINEMET for MERCK, the mylan and MERCK tablets aren't absolutely identical,the mylan is scored, the brand name isn't. and i don't know if the formulas are the same.
Parkinson drug sinemet-LIFE CYCLE STRATEGIC PLAN

"A problem in manufacturing change from Merck to Mylan in 2010 lead to worldwide shortage.  Despite the differences of Mylan Sinemet from Merck Sinemet, it is still more effective than generic formulations"


this is in the presentation:

Non-medicinal ingredients • Crospovidone, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch Storage and stability • Store your tablets at room temperature (15°C–30°C). Store in tightly closed container, protected from light and moisture.

this presentation is very interesting if you want more info on CL in general, it's history and how it works. best quick read i've seen.