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Podsumowanie 2008 - rejestracje i nowości na rynku. Drukuj Email

REJESTRACJE I NOWOŚCI NA RYNKU 2008

 

Minister Zdrowia wydał 753 pozwolenia na dopuszczenie produktów leczniczych do obrotu w Polsce, w tym 736 pozwoleń dla nowych produktów leczniczych i 17 nowych pozwoleń dla produktów leczniczych, które już wcześniej były zarejestrowane. W sumie zostały zarejestrowane 382 marki produktów leczniczych.

Komisja Europejska w ramach procedury centralnej wydała 55 decyzji o dopuszczeniu do obrotu produktów leczniczych przeznaczonych do stosowania u ludzi, w tym 25 decyzji dla produktów leczniczych zawierających nowe substancje czynne lub ich połączenia i 30 decyzji dla produktów leczniczych o substancjach czynnych już wcześniej zarejestrowanych w tej procedurze. W sumie zostało zarejestrowanych 55 marek produktów leczniczych.

Do sprzedaży wprowadzono 227 marek produktów leczniczych.

 

Tabela 1. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku marek produktów leczniczych według pierwszego poziomu klasyfikacji ATC (14 klas).

Klasa ATC

Marki produktów leczniczych

PL

UE

Na rynku

A – Przewód pokarmowy i metabolizm

42

11

28

B – Krew i układ krwiotwórczy

5

5

7

C – Układ sercowo-naczyniowy

78

7

42

D – Leki stosowane w dermatologii

7

0

9

G – Układ moczowo-płciowy i hormony płciowe

17

1

21

H – Leki hormonalne działające ogólnie, z wyłączeniem hormonów płciowych i insulin

0

0

3

J – Leki przeciwzakaźne działające ogólnie

24

7

17

L – Leki przeciwnowotworowe i wpływające na układ odpornościowy

37

12

15

M – Układ mięśniowo-szkieletowy

26

1

16

N – Układ nerwowy

97

7

53

P – Leki przeciwpasożytnicze, środki owadobójcze i repelenty

0

0

0

R – Układ oddechowy

24

2

12

S – Narządy zmysłów

7

1

3

V – Preparaty różne

18

1

1

Suma

382

55

227

Liczba produktów leczniczych rejestrowanych w poszczególnych klasach ATC zależy od różnych czynników. Najważniejsze z nich to: liczba możliwych chorób, do leczenia których leki z danej klasy są przewidziane oraz liczba wygasających w ciągu roku i w poprzedzającym go czasie patentów na sprawdzone w lecznictwie z dobrym skutkiem substancje czynne. Mniejsze znaczenie dla rejestracji w procedurze narodowej oraz w unijnych procedurach wzajemnego uznania i zdecentralizowanej, które są objęte decyzjami Ministra Zdrowia, ma liczba wprowadzanych do lecznictwa nowych substancji czynnych, gdyż większość z nich jest obecnie rejestrowana w ramach unijnej procedury scentralizowanej prowadzonej przez Europejską Agencję Produktów Leczniczych (EMEA). Większość rejestrowanych przez Ministra Zdrowia produktów leczniczych stanowią więc preparaty generyczne. Podobną tendencję daje się już jednak zauważyć wśród produktów leczniczych rejestrowanych centralnie przez Komisję Europejską – w roku 2008 liczba rejestrowanych leków generycznych i biogenerycznych przewyższyła liczbę rejestrowanych leków oryginalnych. Należy też zauważyć, że niektóre podmioty odpowiedzialne rejestrują produkty lecznicze z tą samą substancją czynną i w tych samych prezentacjach pod kilkoma nazwami handlowymi. W ciągu roku następuje też pewna rotacja, gdyż niektóre marki produktów leczniczych są skreślane z Rejestru na wniosek podmiotów odpowiedzialnych, a dla innych pozwolenia wygasają i nie są przedłużane – dla takich produktów leczniczych Ministerstwo Zdrowia jednak nie prowadzi i nie publikuje bieżących statystyk. Należy także pamiętać, że nie wszystkie rejestrowane w danym roku marki są zupełnie nowe – zestawienie obejmuje także marki produktów już obecnych na rynku, dla których jednak rejestrowane są nowe postaci lub dawki.

 

Tabela 2. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie A marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (16 klas).

A – Przewód pokarmowy i metabolizm

Marki produktów leczniczych

PL

UE

Na rynku

A01 – Preparaty stomatologiczne

3

0

1

A02 – Leki stosowane w zaburzeniach związanych z nadkwaśnością

17

0

13

A03 – Leki stosowane w czynnościowych zaburzeniach żołądkowo-jelitowych

0

0

0

A04 – Leki przeciw wymiotom i mdłościom

1

1

1

A05 –- Leczenie wątroby, pęcherzyka żółciowego i dróg żółciowych

2

0

2

A06 – Leki przeczyszczające

1

1

1

A07 – Leki przeciwbiegunkowe, przeciwzapalne i przeciwzakaźne stosowane w chorobach jelit

0

0

0

A08 – Środki do leczenia otyłości

4

0

1

A09 – Leki poprawiające trawienie, włącznie z enzymami

0

0

0

A10 – Leki stosowane w cukrzycy

8

8

7

A11 – Witaminy

5

0

1

A12 – Substancje mineralne

1

0

0

A13 – Preparaty tonizujące

0

0

1

A14 – Leki anaboliczne stosowane ogólnie

0

0

0

A15 – Preparaty pobudzające apetyt

0

0

0

A16 – Inne leki działające na przewód pokarmowy i metabolizm

0

1

0

Suma

42

11

28

Biorąc pod uwagę substancje czynne liderami w klasie A były:

- PL: inhibitory pompy protonowej pantoprazol (8 marek) i omeprazol (7 marek), środek do ośrodkowego leczenia otyłości sibutramina (4 marki), leki stosowane w cukrzycy gliklazyd (5 marek) i metformina (3 marki) oraz witamina kwas askorbinowy (3 marki);

- UE: stosowane w cukrzycy inhibitory peptydazy dipeptydylowej IV (DPP-4) wildagliptyna (2 marki) i sitagliptyna (1 marka) i ich połączenia z metforminą (odpowiednio: 2 marki i 3 marki);

- nowości na rynku: inhibitory pompy protonowej pantoprazol (7 marek), lansoprazol (3 marki) i omeprazol (2 marki) oraz stosowany w cukrzycy glimepiryd (3 marki).

 

Tabela 3. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie B marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (5 klas).

B – Krew i układ krwiotwórczy

Marki produktów leczniczych

PL

UE

Na rynku

B01 – Leki przeciwzakrzepowe

2

4

4

B02 – Leki przeciwkrwotoczne

1

1

0

B03 – Leki stosowane w niedokrwistości

1

0

1

B05 – Substytuty osocza i płyny do wlewów

1

0

2

B06 – Inne preparaty stosowane w hematologii

0

0

0

Suma

5

5

7

W roku 2008 w klasie B każda rejestrowana w PL oraz wprowadzana na rynek marka zawierała inną substancję czynną. Wśród rejestracji w UE liderem był inhibitor agregacji płytek krwi klopidogrel (2 marki)

 

Tabela 4. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie C marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (9 klas).

C – Układ sercowo-naczyniowy

Marki produktów leczniczych

PL

UE

Na rynku

C01 – Leki nasercowe

3

1

4

C02 – Leki obniżające ciśnienie tętnicze krwi

2

1

2

C03 – Leki moczopędne

4

0

2

C04 – Leki rozszerzające naczynia obwodowe

0

1

2

C05 – Leki ochraniające naczynia

2

0

2

C07 – Leki blokujące receptory b-adrenergiczne

16

0

5

C08 – Blokery kanału wapniowego

6

0

4

C09 – Leki działające na układ renina-angiotensyna

33

1

13

C10 – Leki wpływające na stężenie lipidów

12

3

8

Suma

78

7

42

Biorąc pod uwagę substancje czynne liderami w klasie C były:

- PL: inhibitory konwertazy angiotensyny peryndopryl (11 marek) i trandolapryl (3 marki), beta-blokery nebiwolol (11 marek) i bisoprolol (3 marki), inhibitor reduktazy hydroksymetyloglutarylo-koenzymu A simwastatyna (9 marek), bloker kanału wapniowego amlodypina (5 marek), antagonista angiotensyny II losartan (4 marki) i środek moczopędny indapamid (3 marki);

- UE: wpływające na stężenie lipidów połączenie kwasu nikotynowego z laropiprantem (3 marki);

- nowości na rynku: inhibitor reduktazy hydroksymetyloglutarylo-koenzymu A atorwastatyna (6 marek), bloker kanału wapniowego amlodypina (4 marki), antagonista angiotensyny II losartan (3 marki) i nasercowa trimetazydyna (3 marki).

 

Tabela 5. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie D marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (11 klas).

D – Leki stosowane w dermatologii

Marki produktów leczniczych

PL

UE

Na rynku

D01 – Leki przeciwgrzybicze stosowane w dermatologii

4

0

4

D02 – Preparaty zmiękczające i osłaniające

1

0

0

D03 – Środki do leczenia ran i owrzodzeń

0

0

0

D04 – Leki przeciwświądowe, włączając przeciwhistaminowe, znieczulające itp.

0

0

0

D05 – Leki przeciw łuszczycy

0

0

0

D06 – Antybiotyki i chemioterapeutyki stosowane w dermatologii

0

0

2

D07 – Kortykosteroidy – preparaty dermatologiczne

0

0

1

D08 – Środki antyseptyczne i dezynfekujące

0

0

0

D09 – Opatrunki z lekami

0

0

0

D10 – Preparaty przeciwtrądzikowe

2

0

2

D11 – Inne leki dermatologiczne

0

0

0

Suma

7

0

9

Biorąc pod uwagę substancje czynne liderem w klasie D wśród rejestracji PL i nowości na rynku był przeciwgrzybiczy lek działający ogólnie stosowany w dermatologii terbinafina (odpowiednio: 2 marki i 3 marki).

 

Tabela 6. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie G marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (4 klasy).

G – Układ moczowo-płciowy i hormony płciowe

Marki produktów leczniczych

PL

UE

Na rynku

G01 – Leki ginekologiczne przeciwzakaźne i antyseptyczne

1

0

1

G02 – Inne preparaty ginekologiczne

1

0

0

G03 – Hormony płciowe i środki wpływające na czynność układu płciowego

10

0

7

G04 – Leki urologiczne

5

1

13

Suma

17

1

21

Biorąc pod uwagę substancje czynne liderami w klasie G były:

- PL: hormonalne środki antykoncepcyjne działające ogólnie zawierające połączenie drospirenon + etinylestradiol (2 marki), estrogen tibolon (2 marki) oraz leki będące antagonistami receptorów α-adrenergicznych, stosowane m.in. w łagodnym przeroście gruczołu krokowego: alfuzosyna (2 marki) i tamsulozyna (2 marki);

- nowości na rynku: stosowane m.in. w łagodnym przeroście gruczołu krokowego inhibitory 5α-reduktazy testosteronu finasteryd (7 marek) i antagonista receptorów α‑adrenergicznych tamsulozyna (4 marki).

 

Tabela 7. Podział wprowadzonych na rynek w 2008 roku w klasie H marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (5 klas).

H – Leki hormonalne działające ogólnie, z wyłączeniem hormonów płciowych i insulin

 

Marki produktów leczniczych

PL

UE

Na rynku

H01 – Hormony przysadki i podwzgórza oraz ich analogi

0

0

3

H02 – Kortykosteroidy działające ogólnie

0

0

0

H03 – Leki stosowane w chorobach tarczycy

0

0

0

H04 – Hormony trzustki

0

0

0

H05 – Homeostaza wapnia

0

0

0

Suma

0

0

3

W klasie H na rynek wprowadzono 3 różne hormony/analogi przedniego i tylnego płata przysadki.

 

Tabela 8. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie J marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (6 klas).

J – Leki przeciwzakaźne działające ogólnie

Marki produktów leczniczych

PL

UE

Na rynku

J01 – Leki przeciwbakteryjne działające ogólnie

15

1

9

J02 – Leki przeciwgrzybicze działające ogólnie

3

1

3

J04 – Leki przeciwprątkowe

0

0

0

J05 – Leki przeciwwirusowe działające ogólnie

2

1

3

J06 – Surowice odpornościowe i immunoglobuliny

2

1

1

J07 – Szczepionki

2

3

1

Suma

24

7

17

Biorąc pod uwagę substancje czynne liderami w klasie J były:

- PL: antybiotyk przeciwbakteryjny z grupy makrolidów azytromycyna (5 marek), fluorochinolon przeciwbakteryjny ciprofloksacyna (3 marki), działający ogólnie lek przeciwgrzybiczy będący pochodną triazolu flukonazol (2 marki), działający ogólnie lek przeciwwirusowy walacyklowir (2 marki) oraz immunoglobulina ludzka anty-D (2 marki);

- UE: szczepionki przeciw grypie H5N1 (3 marki);

- nowości na rynku: makrolid azytromycyna (4 marki), cefalosporyna drugiej generacji cefuroksym (2 marki) i fluorochinolon cyprofloksacyna (2 marki).

 

Tabela 9. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie L marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (4 klasy).

L – Leki przeciwnowotworowe i wpływające na układ odpornościowy

Marki produktów leczniczych

PL

UE

Na rynku

L01 – Leki przeciwnowotworowe

21

3

7

L02 – Leki hormonalne

14

0

6

L03 – Środki pobudzające układ odpornościowy

1

6

0

L04 – Leki hamujące układ odpornościowy

1

3

2

Suma

37

12

15

Biorąc pod uwagę substancje czynne liderami w klasie L były:

- PL: inhibitor aromatazy anastrozol (11 marek) oraz leki przeciwnowotworowe oksaliplatyna (7 marek), gemcytabina (4 marki) i irynotekan (3 marki);

- UE: czynnik pobudzający wzrost kolonii komórkowych filgrastim (4 marki);

- nowości na rynku: inhibitor aromatazy anastrozol (4 marki).

 

Tabela 10. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie M marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (6 klas).

M – Układ mięśniowo-szkieletowy

Marki produktów leczniczych

PL

UE

Na rynku

M01 – Leki przeciwzapalne i przeciwreumatyczne

16

0

5

M02 – Leki stosowane miejscowo w bólach stawów i mięśni

1

0

4

M03 – Środki zwiotczające mięśnie

3

0

0

M04 – Leki przeciw dnie moczanowej

0

1

0

M05 – Leki stosowane w chorobach kości

6

0

7

M09 – Inne leki stosowane w chorobach układu mięśniowo-szkieletowego

0

0

0

Suma

26

1

16

Biorąc pod uwagę substancje czynne liderami w klasie M były:

- PL: niesterydowy lek przeciwzapalny i przeciwreumatyczny ibuprofen (7 marek) oraz lek wpływający na strukturę i mineralizację kości z grupy bifosfonianów kwas alendronowy (3 marki);

- nowości na rynku: ibuprofen (3 marki) oraz bifosfoniany (4 substancje czynne - w sumie 7 marek).

 

Tabela 11. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie N marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (7 klas).

N – Układ nerwowy

Marki produktów leczniczych

PL

UE

Na rynku

N01 – Środki znieczulające

2

0

0

N02 – Leki przeciwbólowe

9

1

9

N03 – Leki przeciwpadaczkowe

14

1

7

N04 – Leki przeciw chorobie Parkinsona

5

2

1

N05 – Leki psychotropowe

28

2

15

N06 – Psychoanaleptyki

28

1

10

N07 – Inne leki działające na układ nerwowy

11

0

11

Suma

97

7

53

Biorąc pod uwagę substancje czynne liderami w klasie N były:

- PL: lek przeciwpadaczkowy topiramat (10 marek), lek przeciw zawrotom głowy betahistyna (9 marek), neuroleptyki olanzapina (8 marek), kwetiapina (7 marek) i rysperydon (6 marek), leki przeciwdepresyjne wenlafaksyna (7 marek), mirtazapina (4 marki), sertralina (4 marki) i paroksetyna (3 marki) oraz lek przeciw demencji będący inhibitorem cholinesterazy donepezyl (6 marek);

- UE: lek przeciw chorobie Parkinsona będący agonistą dopaminy pramipeksol (2 marki) i neuroleptyk olanzapina (2 marki);

- nowości na rynku: lek przeciw zawrotom głowy betahistyna (9 marek), przeciwpadaczkowy topiramat (5 marek), neuroleptyki rysperydon (4 marki) i kwetiapina (4 marki), przeciwbólowy opioid tramadol (3 marki) oraz leki przeciwdepresyjne (5 substancji czynnych – w sumie 8 marek).

 

W klasie P (leki przeciwpasożytnicze, środki owadobójcze i repelenty) w roku 2008 nie zarejestrowano ani nie wprowadzono na rynek żadnej nowej marki produktu leczniczego.

 

Tabela 12. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie R marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (6 klas).

R – Układ oddechowy

Marki produktów leczniczych

PL

UE

Na rynku

R01 – Preparaty stosowane do nosa

3

2

1

R02 – Preparaty stosowane w chorobach gardła

1

0

1

R03 – Leki stosowane w obturacyjnych chorobach dróg oddechowych

12

0

3

R05 – Leki stosowane w kaszlu i przeziębieniach

4

0

3

R06 – Leki przeciwhistaminowe działające ogólnie

4

0

4

R07 – Inne leki działające na układ oddechowy

0

0

0

Suma

24

2

12

Biorąc pod uwagę substancje czynne liderami w klasie R były:

- PL: lek stosowany w obturacyjnych chorobach dróg oddechowych będący antagonistą receptorów leukotrienowych montelukast (10 marek);

- UE: kortykosteroid do nosa furoinian flutykazonu (2 marki);

- nowości na rynku: lek przeciwhistaminowy działający ogólnie feksofenadyna (2 marki) oraz stosowane w przeziębieniach połączenie ibuprofen + pseudoefedryna (2 marki).

 

Tabela 13. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie S marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (3 klasy).

S – Narządy zmysłów

Marki produktów leczniczych

PL

UE

Na rynku

S01 – Leki okulistyczne

7

1

3

S02 – Leki otologiczne

0

0

0

S03 – Leki okulistyczne i otologiczne

0

0

0

Suma

7

1

3

Biorąc pod uwagę substancje czynne liderami w klasie S były:

- PL: leki przeciw jaskrze - inhibitor anhydrazy węglanowej dorzolamid (3 marki) i sympatykomimetyk brymonidyna (2 marki);

- nowości na rynku: leki przeciwinfekcyjne (2 substancje czynne – w sumie 2 marki).

 

Tabela 14. Podział zarejestrowanych i wprowadzonych na rynek w 2008 roku w klasie V marek produktów leczniczych według drugiego poziomu klasyfikacji ATC (9 klas).

V – Preparaty różne

Marki produktów leczniczych

PL

UE

Na rynku

V01 – Alergeny

0

0

0

V03 – Inne środki stosowane w lecznictwie

4

1

0

V04 – Środki diagnostyczne

0

0

1

V06 – Odżywki

11

0

0

V07 – Wszystkie inne środki nielecznicze

0

0

0

V08 – Środki cieniujące

1

0

0

V09 – Radiofarmaceutyki diagnostyczne

2

0

0

V10 – Radiofarmaceutyki lecznicze

0

0

0

V20 – Opatrunki

0

0

0

Suma

18

1

1

Biorąc pod uwagę przeznaczenie, skład i substancje czynne liderami rejestracyjnymi w PL w klasie V były: odżywki dla dzieci (6 marek) i inne odżywki (6 marek) oraz środek odtruwający flumazenil (2 marki).

 

Tabela 15. Podmioty odpowiedzialne, które zarejestrowały w Polsce w 2008 roku najwięcej marek produktów leczniczych.

Podmiot odpowiedzialny

Marki produktów leczniczych

Teva

21

Sandoz

20

1A-Pharma

12

Actavis

11

Krka

10

Zentiva

10

Tabela 16. Podmioty odpowiedzialne, które zarejestrowały w Unii Europejskiej w 2008 roku w ramach procedury scentralizowanej najwięcej marek produktów leczniczych.

Podmiot odpowiedzialny

Marki produktów leczniczych

Merck Sharp & Dohme

8

Novartis Europharm

5

Janssen-Cilag

2

Krka

2

Ratiopharm

2

Teva

2

Tabela 17. Podmioty odpowiedzialne, które wprowadziły na rynek w Polsce w 2008 roku najwięcej marek produktów leczniczych.

Podmiot odpowiedzialny

Marki produktów leczniczych

1A-Pharma

13

Actavis

9

Ranbaxy

7

Ratiopharm

7

Arrow Generics/Arrow Poland

6

Teva

6

Zentiva

6

Liderem obecnym we wszystkich zestawieniach jest koncern Novartis, do którego należą firmy 1A-Pharma, Sandoz i Novartis Europharm. Biorąc pod uwagę rejestracje polskie i nowe marki na rynku liderami są firmy: Teva (21 + 6 = 27), 1A-Pharma (12 + 13 = 25), Sandoz (20 + 4 = 24), Actavis (11 + 9 = 20) i Zentiva (10 + 6 = 16).

 

 

Opracowanie: dr n. farm. Jarosław Filipek

Kierownik Działu Informacji o Produktach

Administrator Farmaceutycznej Bazy Danych BAZYL

Przygotowanie zestawienia szczegółowego: Krystyna Skrzyńska

IMS Poland

 

 
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