Digest: generic pipeline June 2014 to June 2017

Volume 8
Issue 4
Quarter 2, 2014
Digest: generic pipeline June 2014 to June 2017
Trade Name
(generic name)
Company(ies)
Therapeutic Use(s)
Estimated
U.S. Sales†
Anticipated
Generic
Availability
Anticipated
Launch Type*
$42 million
H2 2014
Exclusive
$460 million
H2 2014
Exclusive with
Authorized Generic
2014
ADVICOR‡
(niacin/lovastatin)
AbbVie
Hyperlipidemia
ASACOL‡
(mesalamine)
Warner Chilcott
Ulcerative Colitis
DIOVAN‡
(valsartan)
Novartis
Hypertension; Heart Failure;
Reduction of Cardiovascular
Mortality after Myocardial Infarction
$2.2 billion
H2 2014
Exclusive
VALCYTE‡
(valganciclovir
hydrochloride)
Roche
Cytomegalovirus (CMV) Disease and
Infection; CMV Retinitis
$195 million
H2 2014
Exclusive
VIRACEPT
(nelfinavir mesylate)
ViiV Healthcare
Human Immunodeficiency Virus
(HIV) Infection
$51 million
H2 2014
Unknown
ORAPRED ODT‡
(prednisolone sodium
phosphate)
Shionogi Pharma
Asthma; Atopic Dermatitis; Allergic
Rhinitis
$33 million
H2 2014
Exclusive
Gastroesophageal Reflux Disease;
Ulcers; Hypersecretory Conditions;
H. pylori Eradication
$6.1 billion
H2 2014
Exclusive
OXYCONTIN‡
(oxycodone hydrochloride
extended-release)
Purdue
Moderate to Severe Pain
$2.5 billion
H2 2014
Competitive
INVEGA
(paliperidone extended-release)
Janssen
Schizophrenia; Schizoaffective
Disorder
$424 million
H2 2014
Competitive
VIVELLE-DOT
(estradiol transdermal patch)
Novartis
Symptoms Associated with
Menopause
$240 million
Q2 2014
Exclusive with
Authorized Generic
NEXIUM‡
(esomeprazole magnesium)
AstraZeneca
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
1
Volume 8
Issue 4
Quarter 2, 2014
Trade Name
(generic name)
Company(ies)
Therapeutic Use(s)
Estimated
U.S. Sales†
Anticipated
Generic
Availability
Anticipated
Launch Type*
$95 million
Q2 2014
Competitive
$147 million
Q2 2014
Exclusive
$1 billion
June 2014
Exclusive
$1.1 billion
July 2014
Exclusive
2014 (continued)
FOSRENOL
(lanthanum carbonate)
Shire
Hyperphosphatemia Associated with
Chronic Kidney Disease
EXALGO‡
(hydromorphone hydrochloride
extended-release)
Mallinckrodt
Moderate to Severe Pain
ACTONEL‡
(risedronate sodium)
Warner Chilcott
Osteoporosis Prophylaxis &
Treatment; Paget’s Disease
NASONEX‡
(mometasone furoate)
Schering/Merck
Seasonal & Perennial Allergic
Rhinitis; Nasal Polyps
LUMIGAN‡
(bimatoprost)
Allergan
Glaucoma; Ocular Hypertension
$367 million
August 2014
Unknown
RENAGEL‡
(sevelamer hydrochloride)
Genzyme
Hyperphosphatemia Associated with
Chronic Kidney Disease
$199 million
September 2014
Unknown
EXFORGE‡
(amlodipine besylate/valsartan)
Novartis
Hypertension
$263 million
October 2014
Exclusive
EXFORGE HCT‡
(amlodipine besylate/valsartan/
hydrochlorothiazide)
Novartis
Hypertension
$93 million
October 2014
Exclusive
Acute Pain & Primary
Dysmenorrhea; Osteoarthritis;
Rheumatoid Arthritis; Ankylosing
Spondylitis
$2.2 billion
December 2014
Competitive
$475 million
December 2014
Exclusive
CELEBREX‡
(celecoxib)
Pfizer
INTUNIV‡
(guanfacine hydrochloride
extended-release)
Shire
Attention Deficit and Hyperactivity
Disorder (ADHD)
2
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
2
Volume 8
Issue 4
Quarter 2, 2014
Trade Name
(generic name)
Company(ies)
Therapeutic Use(s)
Estimated
U.S. Sales†
Anticipated
Generic
Availability
Anticipated
Launch Type*
$3.7 billion
Q1 2015
Competitive
$314 million
February 2015
Unknown
$29 million
February 2015
Exclusive
2015
COPAXONE‡
(glatiramer acetate)
Teva
Multiple Sclerosis
BARACLUDE‡
(entecavir)
Bristol Myers Squibb
Hepatitis B
TARKA‡
(trandolapril/verapamil hydrochloride)
AbbVie
Hypertension
WELCHOL‡
(colesevelam hydrochloride)
Daiichi Sankyo
Primary Hyperlipidemia; Type 2
Diabetes Mellitus
$574 million
March 2015
Competitive
ABILIFY‡
(aripiprazole)
Otsuka
Schizophrenia; Bipolar Disorder;
Adjunct Treatment for Major
Depressive Disorder; Irritability
Associated with Autism
$6.5 billion
April 2015
Competitive
EMEND‡
(aprepitant)
Merck
Chemo-Associated Nausea &
Vomiting; Prevention of Post-Op
Nausea & Vomiting
$114 million
April 2015
Exclusive
OXYTROL‡
(oxybutynin)
Watson
Overactive Bladder
$23 million
April 2015
Exclusive
ZYVOX‡
(linezolid)
Pfizer
Bacterial Infections
$726 million
May 2015
Exclusive
EPIPEN‡
(epinephrine)
Mylan
Anaphylactic Reactions
$300 million
June 2015
Exclusive
CIPRO-HC
(ciprofloxacin hydrochloride/
hydrocortisone)
Bayer
Bacterial Ear Infections
$39 million
June 2015
Unknown
NAMENDA‡
(memantine hydrochloride)
Forest
Moderate to Severe Alzheimer's
Disease
$1.2 billion
July 2015
Competitive
3
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
3
Volume 8
Issue 4
Quarter 2, 2014
Trade Name
(generic name)
Company(ies)
Therapeutic Use(s)
Estimated
U.S. Sales†
Anticipated
Generic
Availability
Anticipated
Launch Type*
$331 million
July 2015
Exclusive
$54 million
July 2015
Exclusive
$690 million
August 2015
Unknown
2015 (continued)
AGGRENOX
(aspirin/dipyridamole
extended-release)
Boehringer Ingelheim
Stroke Prophylaxis
TARGRETIN
(bexarotene)
Eisai
Cutaneous T-Cell Lymphoma
ANDROGEL 1%‡
(testosterone)
AbbVie
Hypogonadism
DAYTRANA
(methylphenidate)
Noven Pharmaceuticals
Attention Deficit Hyperactivity
Disorder (ADHD)
$87 million
September 2015
Exclusive
JALYN‡
(dutasteride/tamsulosin
hydrochloride)
GlaxoSmithKline
Benign Prostatic Hypertrophy
$41 million
Q4 2015
Unknown
AVODART‡
(dutasteride)
GlaxoSmithKline
Benign Prostatic Hypertrophy
$580 million
Q4 2015
Competitive
FROVA
(frovatriptan succinate)
Endo Pharmaceuticals
Migraine Headache
$68 million
November 2015
Exclusive
TRACLEER‡
(bosentan)
Actelion
Pulmonary Arterial Hypertension
(PAH)
$1.6 billion
November 2015
Unknown
PATANOL
(olopatadine hydrochloride)
Alcon
Allergic Conjunctivitis
$230 million
December 2015
Competitive
ORTHO TRI-CYCLEN LO‡
(ethinyl estradiol/norgestimate)
Janssen
Prevention of Pregnancy
$425 million
December 2015
Competitive
4
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
4
Volume 8
Issue 4
Quarter 2, 2014
Trade Name
(generic name)
Company(ies)
Estimated
U.S. Sales†
Anticipated
Generic
Availability
Anticipated
Launch Type*
GLEEVEC‡
(imatinib mesylate)
Novartis
Chronic Myeloid Leukemia; Acute
Lymphoblastic Leukemia;
Gastrointestinal Stromal Tumors;
Myelodysplastic Syndrome;
Aggressive Systemic Mastocytosis;
Hypereosinophilic Syndrome or
Chronic Eosinophilic Leukemia;
Dermatofibrosarcoma Protuberans
$1.9 billion
February 2016
Exclusive
GLUMETZA‡
(metformin hydrochloride
extended-release)
Santarus
Type 2 Diabetes Mellitus
$58 million
February 2016
Exclusive
ENABLEX‡
(darifenacin hydrobromide)
Warner Chilcott
Overactive Bladder
$268 million
March 2016
Competitive
EPZICOM
(lamivudine/abacavir sulfate)
ViiV Healthcare
Human Immunodeficiency Virus
(HIV) Infection
$375 million
March 2016
Unknown
CRESTOR
(rosuvastatin calcium)
AstraZeneca
Hyperlipidemia
$5.3 billion
May 2016
Exclusive
NUVIGIL‡
(armodafinil)
Teva/Cephalon
Excessive Daytime Sleepiness
$420 million
June 2016
Exclusive
ZIANA
(clindamycin phosphate/tretinoin)
Medicis
Acne
$149 million
July 2016
Exclusive
ADVAIR DISKUS‡
(fluticasone propionate/
salmeterol xinafoate)
GlaxoSmithKline
Asthma; Chronic Obstructive
Pulmonary Disease
$5.1 billion
August 2016
Unknown
FLOVENT DISKUS
(fluticasone propionate)
GlaxoSmithKline
Asthma; Chronic Obstructive
Pulmonary Disease
$1.3 billion
August 2016
Unknown
TAMIFLU
(oseltamivir phosphate)
Gilead Sciences
Prevention and Treatment of
Influenza
$641 million
August 2016
Unknown
Therapeutic Use(s)
2016
5
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
5
Volume 8
Issue 4
Quarter 2, 2014
Trade Name
(generic name)
Company(ies)
Therapeutic Use(s)
Estimated
U.S. Sales†
Anticipated
Generic
Availability
Anticipated
Launch Type*
2016 (continued)
BENICAR‡
(olmesartan medoxomil)
Daiichi Sankyo
Hypertension
$832 million
October 2016
Exclusive
BENICAR HCT
(olmesartan medoxomil/
hydrochlorothiazide)
Daiichi Sankyo
Hypertension
$81 million
October 2016
Exclusive
AZOR
(olmesartan medoxomil/
amlodipine besylate)
Daiichi Sankyo
Hypertension
$245 million
October 2016
Competitive
SEROQUEL XR
(quetiapine fumarate
extended-release)
AstraZeneca
Schizophrenia; Bipolar Disorder;
Adjunct Treatment for Major
Depressive Disorder
$1.2 billion
November 2016
Exclusive
ZETIA
(ezetimibe)
Merck
Hyperlipidemia
$1.7 billion
December 2016
Exclusive
NORVIR
(ritonavir)
AbbVie
Human Immunodeficiency Virus
(HIV) Infection
$386 million
December 2016
Exclusive
RELPAX‡
(eletriptan hydrobromide)
Pfizer
Migraine Headache
$201 million
December 2016
Exclusive
ZYTIGA
(abiraterone acetate)
Janssen
Prostate Cancer
$775 million
December 2016
Unknown
2017
AZILECT‡
(rasagiline mesylate)
Teva
Parkinson’s Disease
$493 million
February 2017
Competitive
VYTORIN
(simvastatin / ezetimibe)
Merck
Hyperlipidemia
$859 million
April 2017
Competitive
6
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
6
Volume 8
Issue 4
Quarter 2, 2014
Trade Name
(generic name)
Company(ies)
Therapeutic Use(s)
Estimated
U.S. Sales†
Anticipated
Generic
Availability
Anticipated
Launch Type*
$444 million
May 2017
Competitive
$51 million
June 2017
Unknown
2017 (continued)
STRATTERA
(atomoxetine hydrochloride)
Eli Lilly
Attention Deficit Hyperactivity
Disorder (ADHD)
GABITRIL‡
(tiagabine hydrochloride)
Cephalon
Epilepsy
†Financial
data compiled from available annual and quarterly pharmaceutical company reports, IMS Health, Thomson Cortellis, analyst reports, and
company press releases.
*Authorized
Generic = An “authorized generic drug” is a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the Federal
Food, Drug and Cosmetic (FD&C) act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other
than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade
mark that differs from that of the listed drug. For FDA listing of authorized generics, please visit:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm126391.htm; Competitive (also referred to as
“multisource”) = Denotes that more than one generic manufacturer is eligible to launch a generic equivalent by the anticipated availability date assuming
FDA approval; Exclusive = Denotes that one generic manufacturer will be eligible to launch a generic equivalent by the anticipated availability date assuming
FDA approval. Typically, the exclusive generic manufacturer will be eligible for a 180-day period of marketing exclusivity beginning either from the date it
begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed,
whichever is first.
‡Comments
-ABILIFY: Competitive launch applies to ABILIFY tablets and ABILIFY DISCMELT; Teva/Barr is anticipated to launch generic ABILIFY oral solution with 180-day
exclusivity after the pediatric exclusivity associated with the '528 patent expires on April 4, 2015.
-ACTONEL: Mylan, Sun and Apotex announced launch of their generic ACTONEL 150 mg on June 11, 2014. Generics also anticipated for ACTONEL 5 mg,
30 mg, and 35mg. Generics also anticipated for ACTONEL WITH CALCIUM; however, the brand product has been discontinued per the FDA web site. Sales
figure includes ACTONEL/ATELVIA.
-ADVAIR DISKUS: The FDA released new draft guidance for the development of generic versions, requiring only "relatively basic" preclinical tests and a short
clinical trial.
-ADVICOR: Teva has a settlement agreement allowing launch any time after September 20, 2013. It is unknown when or if Teva will launch its generic.
Other generics are not expected to launch until March 2018.
-ANDROGEL: Perrigo received approval for a testosterone gel product in January 2013 via a new drug application (NDA). It is not a FDA-approved generic
equivalent for ANDROGEL.
-ASACOL: Generic availability applies to ASACOL 400 mg tablets. Brand name ASACOL 400 mg tablet has been discontinued; Warner Chilcott has released
DELZICOL 400 mg that contains the same amount of mesalamine in a delayed-release capsule. Zydus will have an opportunity to launch generic ASACOL
HD 800 mg in November 2015.
-AVODART: Barr received FDA approval for generic AVODART on December 21, 2010. Banner received FDA approval for generic AVODART on May 30, 2013.
-AZILECT: Actavis, Apotex, and Orchid have settlement agreements allowing launch shortly prior to February 7, 2017. Actavis and Apotex received FDA approval
for generic AZILECT on July 1, 2013 and September 12, 2013, respectively.
-BARACLUDE: Teva may have an opportunity to launch "at risk" upon FDA approval at any time.
-BENICAR: Exclusive generic launch is uncertain.
-CELEBREX: Under settlement agreements, Teva, Mylan, and Actavis may launch their generic celecoxib capsules in December 2014, or earlier under
certain circumstances. FDA has granted exclusivity to Teva. Mylan may launch an authorized generic in December 2014.
7
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
7
Volume 8
Issue 4
Quarter 2, 2014
-COPAXONE: Mylan, Sandoz, and Synthon could launch generic COPAXONE after May 24, 2014. Generic availability applies to the 20 mg strength. The US
Supreme Court will hold a hearing in October 2014; Mylan and Sandoz likely not to launch 'at risk' until hearing is completed. Teva has recently launched a
40 mg strength of COPAXONE that is given three times weekly. COPAXONE 40 mg has patent protection until 2030.
-DIOVAN: FDA has failed to approve Ranbaxy’s generic, but has extended Ranbaxy’s exclusivity period. A Citizen's Petition was filed on June 5, 2014 asking the
FDA to forfeit Ranbaxy's exclusivity and approve other generics.
-EMEND: Generic availability applies to the oral formulation only. If pediatric exclusivity is granted, Sandoz may not launch generic EMEND until October
2015.
-ENABLEX: If pediatric exclusivity is granted, generic ENABLEX may not be launched until June 15, 2016.
-EPIPEN: There are several auto-injectable epinephrine products on the market; however, they are not A-rated to EPIPEN. They cannot be substituted for
EPIPEN.
-EXALGO: Actavis announces launch of generic EXALGO 8, 12 & 16 mg strengths on April 21, 2014. Generic availability of the 32 mg strength is expected on
May 15, 2014 pursuant to a settlement agreement.
-EXFORGE: Par received FDA approval of generic EXFORGE on March 28, 2013.
-EXFORGE HCT: Teva received FDA approval of generic EXFORGE HCT on September 25, 2012.
-GABITRIL: Generics anticipated for 12 and 16 mg strengths only. Other strengths of GABITRIL are already generically available.
-GLEEVEC: Exclusive generic launch is uncertain. Novartis reached a settlement agreement with Sun permitting launch of generic GLEEVEC 100 mg and 400
mg on February 1, 2016.
-GLUMETZA: Lupin received FDA approval of generic GLUMETZA on July 19, 2013. Santarus reached a settlement agreement with Lupin permitting launch of
generic GLUMETZA on February 1, 2016.
-INTUNIV: Actavis received FDA approval of generic INTUNIV on October 5, 2012. Actavis has a license to market its generic INTUNIV beginning December 1,
2014.
-JALYN: Anchen/Par received FDA approval of generic JALYN on February 26, 2014.
-LUMIGAN: Generic availability applies to LUMIGAN 0.03%; generic availability of LUMIGAN 0.01% is anticipated on June 13, 2027 pending the outcome of
ongoing patent litigation.
-NAMENDA: Generic availability applies to oral tablets; patent expiration of the oral solution formulation is April 15, 2015. Forest reached settlement
agreements with Amneal, Actavis, Dr. Reddy's, Lupin, Mylan, Orchid, Sun, Teva, Upsher-Smith, and Wockhardt permitting launch of generic NAMENDA on
January 11, 2015. NAMENDA brand 5 mg and 10 mg are being discontinued in Fall 2014. NAMENDA XR is available in 7, 14, 21, and 28 mg extended--release
capsules; the patent expires in November 2026.
-NASONEX: An “at risk” launch is possible at any time if the FDA grants effective approval to Apotex’s generic NASONEX product.
-NEXIUM: Generic availability applies to the oral formulations (capsules, granules); Ranbaxy has to acquire raw materials from another company; therefore,
launch of its generic NEXIUM may be delayed. A Citizen's Petition was filed on June 5, 2014 asking the FDA to forfeit Ranbaxy's exclusivity and approve
other generics. Sun launched generic NEXIUM IV in January 2014. Another salt form, esomeprazole strontium, by Amneal was approved by the FDA on
August 8, 2013. This is not A-rated to NEXIUM. Amneal launched brand name esomeprazole strontium in December 2013 and an authorized generic by
the same name in January 2014. Pfizer launched an over-the-counter NEXIUM 20 mg, NEXIUM 24HR, on May 27, 2014.
-NUVIGIL: Mylan received FDA approval of generic NUVIGIL 50 mg, 150 mg and 250 mg on June 1, 2012. Actavis received FDA approval of generic NUVIGIL
100 mg and 200 mg on August 29, 2012. NUVIGIL brand 100 mg has been discontinued. Teva has reached settlement agreements with Actavis, Lupin,
Mylan, Apotex and Sandoz. Actavis may launch generic NUVIGIL 100 mg and 200 mg in June 2016. Others may launch 100 mg and 200 mg 180-days after
Actavis. Mylan may launch generic NUVIGIL 50 mg, 150 mg and 250 mg sometime in June 2016. Others may launch 50 mg, 150 mg and 250 mg 180days after Mylan.
-ORAPRED ODT: Mylan received FDA approval of generic ORAPRED ODT on April 10, 2013. Settlement agreement allows launch after April 1, 2014.
-ORTHO TRI-CYLEN LO: Teva/Barr, Actavis, and Lupin received FDA approval of generic ORTHO TRI-CYLEN LO on June 29, 2009, March 9, 2011, and June
25, 2012, respectively.
8
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
8
Volume 8
Issue 4
Quarter 2, 2014
-OXYCONTIN: Purdue reached settlement agreements with Actavis, Impax, Par and Sandoz. Actavis may launch its generic OXYCONTIN (new abusedeterrent formulation) any time after receiving FDA approval. Impax may launch its generic OXYCONTIN as early as 2016. Par and Sandoz’s settlement
agreement terms have not been disclosed.
-OXYTROL: Teva received FDA approval of generic OXYTROL on March 4, 2014. Actavis reached a settlement agreement with Teva permitting launch of generic
OXYTROL on April 26, 2015 or earlier under certain circumstances. An OTC product, OXYTROL for WOMEN became available in September 2013 for the
treatment of overactive bladder in women.
-RELPAX: If pediatric exclusivity is granted, Apotex may not launch generic RELPAX until June 26, 2017.
-RENAGEL: Under a settlement agreement, Endo has permission to launch generic as of March 16, 2014. Impax, Lupin, Sandoz and InvaGen have
permission to launch on September 16, 2014, or earlier under certain circumstances.
-TARKA: Glenmark received FDA approval of generic TARKA on August 20, 2010. In January 2011, a US district court upheld the validity of AbbVie's ‘244
patent for TARKA, maintaining coverage to February 2015.
-TRACLEER: Sales figure of $1.6 billion is worldwide sales.
-VALCYTE: Ranbaxy’s generic VALCYTE was originally expected to launch in September 2013. Ranbaxy’s manufacturing facility is under review by the FDA; it is
unknown when the generic will receive approval by the FDA. A Citizen's Petition was filed on June 5, 2014 asking the FDA to forfeit Ranbaxy's exclusivity and
approve other generics.
-WELCHOL: Generic availability applies to oral tablets and granules for suspension. Oral tablets may launch as exclusive.
-ZYVOX: Teva received FDA approval of generic ZYVOX injection on June 27, 2012. It is unknown when Teva plans to launch under the terms of a settlement
agreement with Pfizer. Oral tablets and suspension are expected to launch in May 2015.
9
Prepared by:
V. Taylor, PharmD
Clinical Pharmacist, Pipeline & Trend Surveillance; Drug Intelligence
Catamaran
Reviewed by:
Sherry Andes, PharmD, BCPS, BCPP, BCACP, CGP, PAHM
Manager, Pipeline & Trend Surveillance; Drug Intelligence
Catamaran
RxOutlook® presented by Catamaran LLC Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative
processes. Data are compiled from both public and private sources. Content is for informational use only; any actions, judgments, or forecasting should be made solely at the risk and discretion of the reader.
© 2014 Catamaran LLC. All rights reserved. Catamaran is a registered trademark of Catamaran LLC.
9

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