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Generic Harvoni in India (part 2)

This is a continuation of our discussion about development and production of generic forms of Harvoni in India.  Please remember that our Terms of Use prohibit posting links without prior permission from MedHelp.  Under no circumstances do we permit posting of contact information (email addresses, addresses, phone numbers, etc.), links to sales or community sites, or promotions/advertising.

Thanks.

(click here to read the archived discussion):
http://www.medhelp.org/posts/Hepatitis-C/Generic-Harvoni-in-India/show/2451872
197 Responses
Avatar universal
1st week December is next week, but it wont go on sale for another 2 weeks after that if it is out.
1 Comments
I want to get related information, could i  take part in the discussion? Please tell me
Avatar universal
Bristol-Myers Squibb Co. has signed a broad agreement with Medicines Patent Pool, allowing the United Nations-backed organization to distribute licenses for generic-drug companies to copy its hepatitis C treatment in more than 100 developing and middle-income nations.
The agreement allows the generics makers to produce copies of the drug Daklinza, known chemically as daclatasvir, without paying any royalties, Medicines Patent Pool said in a statement Monday. The liver ailment is a new treatment area for the organization, which has helped developing nations gain access to HIV medicines.
Almost two-thirds of all patients living with hepatitis C reside in the countries included in the pact, giving residents access to treatments at reduced costs. The expense of hepatitis C drugs in the U.S. has garnered criticism by insurers and politicians, and the IMS Institute for Healthcare Informatics estimates that the treatments will cost $48 billion by 2020, out of a $1.4 trillion global pharmaceuticals bill.
About 130 million to 150 million people worldwide are infected with hepatitis C, and 500,000 die each year, according to the World Health Organization.
Drugmakers in India have been wanting to make cocktails combining the Bristol Myers medicine with Gilead Sciences Inc.’s Sovaldi. That combination pill would be impossible in western nations due to patent protections. Gilead last year licensed 11 generic drugmakers including Hetero Labs Ltd., Cipla Ltd. and Aurobindo Pharma Ltd. to make and sell generic version of the Gilead drug, known chemically as sofosbuvir, in 101 developing countries. Those agreements also allow the development of combination medicines with other companies’ drugs, Gilead said in October.
Bristol-Myers has dialed back its virology program after Gilead and AbbVie Inc. came to dominate the Western market with their treatments. The New York-based drugmaker has treated more than 50,000 Japanese patients with a combination of daclatasvir and another drug called asunaprevir, and is seeking to build a market in China, according to spokesman Robert Perry.
“The MPP royalty-free agreement is one key element of Bristol-Myers Squibb’s broad plan to support global access to Daklinza,” Perry said in an e-mail. “There were a number of factors that we considered when determining which countries to include in the licensing territory, including economic development, burden of disease and government health systems’ resources for addressing treatment and care.”
The European Commission in August last year approved Daklinza for use in combination therapy across subtypes of the virus 1, 2, 3 and 4, which together account for 94 percent of the world’s hepatitis C cases -- meaning that a combined regimen could be effective in a wide swath of patients.
Avatar universal
I got my result from taking Twinvir for 2 weeks.
Viral load (HCV RNA) went from 2 million+ to Not Detected!
I have felt pretty good during the 2 weeks I have been taking Twinvir ... bursitis and other pains started disappearing ... it felt like Twinvir must be helping. Now I know. I hope this encourages any who are worried about medicine from Bangladesh.
4 Comments
Great news. Thanks for the update. Very encouraging.
Awesome and Heartiest congratulations palviet , yes Bangladesh meds work very well .
Wishing you all the best .

Congratulations mate
Congretulations
Avatar universal
any news about generic harvoni in india
1 Comments
No sir.
Avatar universal
i just finished up 2 weeks of twinvir at the beginning of this week. For 2 days this week, my side effects were horrendous. It felt like about month 4 of interferon treatment (which i had 10 yrs ago - and failed).
The problems are beginning to subside a bit now, but man, it was pretty damn bad.
My HAIR hurt, my teeth itched and hurt, my muscles screamed yet my bones felt soft.
Golfballs replaced my eyeballs and a midget was in my head smacking them with a 3 iron all day long....

and so on...

it seems the worst of that is over, but the golf ball effect still persists. Oh well... the wheels on the bus go round and round
1 Comments
There's something wrong with you
Avatar universal
Drink your water!  That is the simplest thing and it really helps alleviate many of the side effects, yet seems to be the hardest for people to do.  You should be drinking one ounce per pound of weight up to 1/2 of your body weight each day (that was a lot of water in my case, but I did it.  You can, too), more if you drink anything caffeinated.

Good luck, so glad your sides are getting better.  Truly, it is worth the sides, when you reach SVR!

Blessings,

Pat
Avatar universal
i drink water... believe me. I live in Thailand for 7 yrs now and i always keep hydrated... well hydrated. I drink a few liters of water every day.
Right now i urinate probably a dozen times a day.

I'll float away if i drink more water! But thanks for the thought.
Avatar universal
It sounds like I have had an easy go compared to you. I don't know why. The only difference that I know of is I was treatment naive when I started Twinvir - so, this is the first time the little hcv buggers got wacked with anything - and in my case, Twinvir took them right down. Also, I only had about 2.5 million to wipe out. I am still doing 24 weeks since I am F4 (according to my dr) and, I don't want to be penny wise and dollar foolish, and have this come back again, just because I stopped at week 12, instead of week 24. Let us know what you test results show.  
Avatar universal
my viral load was 9 million... and 3 key liver tests were 2-300 % above normal.
Yes, the question of previous treatment is an interesting one and perhaps having gone through 6 months of interferon and ribovarin and all the other drugs they filled me with, actually did cause it to mutate or something. Who knows?
Won't have more tests until 8 weeks into tx, unless i just want to go spend more money - which is not appealing to me right now.

Todays new additions to the menu from hell included numbness in my lips... as in like when you go to the dentist and after you leave you try to drink some water... and water drips out of you mouth cuz you can not control your lips... exactly that is happening to me all day long.

good news is that for about 4 hours the golfers in my head must have stopped at the 19th hole and had a few drinks cuz i could actually see normally...

we count our little victories... no matter how small
1 Comments
Dear Zippy , congrats on starting your tx , i too am on lesovir -c week 7 now .
I would suggest that you get your blood pressure checked , i nver had a problem with Bp , but within 3 days of starting the treatment my head was pounding and the doc checked my bp , it was 155/ 105 . i have been since put on bp medication and headaches are much better now ( still get some in the mornings ) , another problem i am facing is called " Tinitus " its a constant " Siren " like sound / birds chirping / ringing in the ears which has started since i took this med and is pretty loud and disturbing .

Fatigue and feeling tired are also some of my complaints , but i had those even when i was not on medication , so i wont complain much about that ...

Just remember that you will beat the virus and these are sides and will go away once you complete your treatment if not sooner ...

take care and hang in there ...

My best wishes to you ....

Avatar universal
I have been losing slight control of some facial muscles, mainly around my eyes... all of a sudden, my daughter says: daddy, why is your left eye drooping?

I have so much discomfort around my eyes anyways, i don't even notice it, but it is evident to anyone who looks at my face, apparently.

I just hope that in the menu of side-effects i am moving off the "main courses" and at least nearing the dessert part of the menu.
2 Comments
this does not seem like a side effect of Harvoni , you should seek an appointment with your hepatologist at the earliest and get it checked out ...

best wishes always
I agree pacman, this guy is completely sick, and yet he keeps posting this horror
Avatar universal
Who has the news about generic harvoni in india? For a general harvoni in Nepal, I just asked a pharmaceutical research and development manager, he said that Nepal general harvoni quality uncertainty, suggested  I use twinsvir, if the India general  harvoni in December harvoni  be released, I will consider twinsvir!
7 Comments
quality is same as chemical is same. Nobody can help as to when Indian Harvoni will be released so you just wait or get twinvir which others are using. I will also get twinvir if its not released in India soon
not  be released
For shelf life problem, he expressed doubts about the quality, he is a manager of pharmaceutical, are clear
how much you can buy twinvir  ?

you need it for 3 months, shelf life is 2 years. Twin is about $ 1000 in Bangladesh for 12 week treatment.
I know this  thinks , In our country, need 1377 usd to buy twinvir
$1377 is a good price if you can get it in your country , imagine the amount u will save on travelling .
Also as Darbara said , nothing is certain about Harvoni release in India , i am hearing next week , next week , every day , but next week is not coming . ...

best of luck and hope you get your twinvir and start soon ...
Thank you for your blessing, I also think that India general harvoni uncertainty, I am thinking!
Avatar universal
woke up today and about 70% of the symptoms have gone away.
I was conferring with Dr. Freedman in Australia and he has now suggested that because i was F4 on Fibroscan, indicating cirrhosis, that whatever symptoms i develop, they linger a bit longer in my system.
Nonetheless, i will go get eye pressure checked just to make sure my eyes have not suffered any damage from this recent bout of side-effects.
2 Comments
Get well soon !
Hi there, I am so sorry for your experience.  I had awful side effects that others didn't when I treated.  I think it was because my liver was more damaged than others.
Avatar universal
Daclatasvir launching December 1st week In India, followed by Generic Harvoni
10 Comments
sof + dac is for all genotypes, so I gues there is no reason to lauch separately
Will you wait for generic harvoni?
Are you sure? Is it true? When will the harvoni launch?
2 weeks, They have the got the approval, SO NO CLINICAL TRIAL
@ takataka yes I will wait for it
you say harvoni launch in 2 weeks?
yes I believe so today
it went to the point that we knew since june. mid december
as long  as it comes thats all, but many many Indians are genotype 3 so for them sovaldi was a boon which came out in March
It is almost certain now that generic a Harvoni will be launched around mid December. A prominent Pharma company has already called its reps for training in sale of this drug. Now it's worth waiting.
Avatar universal
If anyone finds the minutes of the CDSCO/CENTRAL DRUGS STANDARD CONTROL ORGANIZATION ( India) meeting of 27.11 please message me the link
4 Comments
What is that? The approval of generic harvoni in india?
yes, the legal statement
why dont beging sales by monday?
permissions
Avatar universal
Dear all , Hello and i am happy to report to everyone that todays newspaper says " trials for ledipasvir and daclasavir  " have been waived by the cdsco "  
combinations of ledi and sofo and also dac will be available in india in the coming weeks as per the article .
My best wishes to all ...

here is the article in the paper .....
http://timesofindia.indiatimes.com/home/science/Hepatitis-C-cure-may-cost-as-low-as-Rs-67k/articleshow/49966218.cms
10 Comments
Great
you were the 1st person i thought of when i saw this darbara ... now u can go ahead and tx soon :)
That's great ... surely a big relief . Thanx Pacman .
thanks much
There will be a combo sof+dac in one pill?
Or just daclatasvir pill?
yes ! it Would be likely to  have a combo sof+dac in one pill for beacon ,  the beacon Senior Vice President says
@ xIAOmizhou Do you have Hepatitis C ?
yes, i am 1b Patients ,also is a students, any you? 1a?
In our China, there has been no news about India's general harvoni and dac !
yes 1a
Avatar universal
"The waiver for sofosbuvir and ledipasvir co-formulation and for daclatasvir is expected to bring the generic version of these drugs, which cost a fraction of the branded versions, into the Indian market within weeks."

two to three weeks I am afraid it will take. But now it is sure
Avatar universal
Our sincere endeavour is to launch the product in India as well, towards this we are taking all the required measures to get it approved for marketing in India. As of now, we will not able to commit on any tentative dates for the launch in India.



Hepcinat-LP(LEDIPASVIR+SOFOSBUVIR) is available for sale only in Nepal against the prescription of a Hepatologist in Nepal.(For patients who are getting treated in Nepal).



Note: The Molecule / Brand is only made available for marketing in NEPAL. We hold no liability if they are offered / sold outside this country where patent laws applicability exists or otherwise.



With Regards,

Marketing Team
Natco Pharma
9 Comments
What aspects of the problem? the Time has not yet been set?

I saw Greg's blog, he said there was no release time for india harvoni!

There is paperwork to be done before release so that will take 2-3 weeks atleast. But it has to come as they have got the required permissions. So by end December only as far as I see the situation.
what time about dac ?
Natco pharma will release it. I think 15th December.
There should be 8 brands of generic Harvoni in India shortly.
8 brands!!!
If India don't release the general harvoni, their market will be occupied completely by twinvir
No it wont. India works slow BUT it works
I can only hope that can be released quickly!
yes before 2016 !!!!
16237568 tn?1449378153
So does this means that dac is still not legal in India?
I am waiting to buy it here in India at a good price.
1 Comments
Its legal but the producer has to release it for sale in the market.
You can contact Natco pharma they reply fast and ask them
16237568 tn?1449378153
I was thinking more about importing it from Bangladesh now, quicker, but my question is that is it legal now in India? Does it mean that I don't have to fill in Form 12a for DCI permission to import in the country?
By the way, Natco are not the most friendly. They refused to even give me the price of their product simply because my name is not an indian name, claiming their product was for sale only to patient treated in India with an Indian doctor prescription.  Meanwhile I bought Hep cinat from an Indian chemist no questions asked. I am not Indian but I am here working in India for 6 months.
2 Comments
Just hang on this month it will come. Yes if you import it you need that form 12a
Its legal now for an Indian pharma company like Natco to manufacture it and sell it in India. They have applied for the trademark under the name of NATDAC
The news from some quarters is coming that Dac will be released before Harvoni . So December release is almost sure. Natco is going to launch it first. Just wait u will get it soon in India.
Avatar universal
Continue to have good news, although our country only has  A  few  people waiting for India general harvoni !
Avatar universal
Dear All
Following is the answer given by Natco Pharma to my query about release of generic Harvoni. Now the next obstacle is the Product License . They cannot manufacture a product unless they get a license. Hope all this process gets cleared in December.  But December release doesn't seem sure.  Let's hope.

Natco's Response to my email query:-

"Clinical trial waiver granted by CDSCO for Ledipasvir is certainly a great news for all the Chronic Hepatitis ‘C’ patients. We are awaiting our product(Ledipasvir+Sofosbuvir) to be licenced for manufacturing and marketing by the drug controller general of India. As soon as we receive the licence ,we should be able to provide you the launch dates."

Regards,
Marketing Team
8 Comments
I think when to be released for companies is a secret, because the relationship to the stock
Yeah, that may be the reason. They don't always share the confidential information.
There are 8 pharma companies to get the licence for Harvoni, its competition. In Hep C medicines Natco has been ahead with its releases. There is Hetero, Mylan, Cadilla, Cipla, Dr Reddys...... they will not all get the licence immediately but one of them will release it this month and the rest will follow. The first release will be the most expensive at $ 380 ( Rs. 25000 ) per bottle of 28. The price will then fall.
Do you think the first would be natco?
yes as they have Hepcinat -LP selling in Nepal and the same  trademark is registered in India too. They also have another trademark Hepcinat-L
Both these is for Harvoni release in India.
Do Natco already has the license to manufacture it in India for selling it in India ??
no, they have applied for it and the trademarks
if they had licence to sell it would be on sale now
Avatar universal
Hepcinat-L is india version, Ledifos is india version

Hepcinat Lp is nepal version, Lisof is nepal version
1 Comments
There is no versions in India as yet........
Avatar universal
Trademark : HEPCINAT-LP      Class : 5
Application Date :  2015-07-27
Status :  New Application
Goods and Services Description :  Medicinal and pharmaceutical preparations
Applicant Address :  NATCO HOUSE, ROAD NO.2, BANJARA HILLS, HYDERABAD- 500 034. TELANGANA
Avatar universal
Trademark : LEDIFOS      Class : 5
Trademark Applicant :  Hetero Healthcare Limited
Application Date :  2015-04-21
Status :  Formalities Chk Pass
Goods and Services Description :  Pharmaceuticals, medicinal and veterinary preparations.
Applicant Address :  7-2-A-2, Hetero Corporate, Industrial Estate, Sanathnagar, Hyderabad-500018.
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