Ziagen
`300 mg
`600 mg/300 mg Epzicom
`
`300 mg/150
`mg/300 mg
`250 mg
`
`Trizivir
`
`Zytiga
`
` DATE OF
`
`SUBMISSION
`1/28/2009
`9/27/2007
`
`3/22/2011
`
`4/28/2015
`
`25 mg, 50 mg
`and 100 mg
`200 mg/mL, 30
`mL vials
`
`1000 mg/100
`mL (10 mg/mL)
`650 mg
`
`325 mg/ 37.5
`mg
`250 mg/250
`mg/
`65 mg
`50 mg/mL, 10
`mL and 20 mL
`vials
`0.30%
`0.1%/2.5%
`
`Precose
`
`3/22/2005
`
`Acetadote
`
`4/4/2012
`
`Ofirmev
`
`4/7/2011
`
`Tylenol
`
`Ultracet
`
`Excedrin
`(migraine)
`
`Zovirax
`
`Differin
`Epiduo
`
`9/15/2009
`12/30/2011
`
`10 mg
`3 mg/mL, 20 mL
`and 30 mL vials
`
`Hepsera
`Adenoscan
`
`6/8/2010
`4/16/2005
`
`2 mg(base)/
`5 mL
`4 mg and 8 mg Volmax
`
`Ventolin
`
`0.021% and
`0.042%
`0.083%/ 0.017% Duoneb
`
`Accuneb
`
`10/19/2005
`
`Abacavir Sulfate
`Abacavir Sulfate and
`Lamivudine
` Abacavir Sulfate,
`
`Lamivudine and Zidovudine
`Abiraterone Acetate
`
`Tablets
`Tablets
`
`Tablets
`
`Tablets
`
`Acarbose
`
`Acetylcysteine
`
`Tablets
`
`Injection
`
`Acetaminophen
`
`Injection
`
`Acetaminophen
`
`Acetaminophen and
`Tramadol Hydrochloride
`
` Acetaminophen/ Aspirin/
`Caffeine
`
`Extended-release
`Tablets
`Tablets
`
`Tablets
`
`Acyclovir Sodium
`
`Injection
`
`
`
`Adapalene
` Adapalene and Benzoyl
`Peroxide
`Adefovir Dipivoxil
`Adenosine
`
`Topical Gel
`Gel
`
`Tablets
`Injection
`
`Albuterol Sulfate
`
`Oral Syrup
`
`Extended-release
`Tablets
`Inhalation Solution
`
`Inhalation Solution
`
`Albuterol Sulfate
`
`Albuterol Sulfate
`
` Albuterol Sulfate/
`
`Ipratropium Bromide
`Albuterol Sulfate
`
`Alcaftadine
`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Inhalation Aerosol
`
`0.09 mg base
`per actuation
`Ophthalmic Solution 0.25%
`
`Pro-Air HFA
`
`5/18/2012
`
`Lastacaft
`
`7/30/2014
`
`Alendronate Sodium*
`Alendronate Sodium
`
`Oral Solution
`Tablets
`
`70 mg/75 mL
`5 mg, 10 mg, 35
`mg, 40 mg and
`70 mg
`
`Fosamax
`Fosamax
`
`9/7/2007
`
`Page 1
`
`SENJU EXHIBIT 2106
`LUPIN v SENJU
`IPR2015-01105
`
`PAGE 1 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
` DATE OF
`
`SUBMISSION
`11/20/2007
`
`
`
` Fosamax Plus
`D
`
`Alendronate Sodium and
`Cholecalciferol
`
`Tablets
`
`Alfuzosin Hydrochloride
`
`Aliskiren Hemifumarate
`
`Extended-release
`Tablets
`Tablets
`
` 70 mg/2800 IU
`
`and 70 mg/5600
`IU
`10 mg
`
`150 mg and 300
`mg
`
`Aliskiren Hemifumarate and
`Hydrochlorothiazide
`
`Tablets
`
`Almotriptan Malate
`
`Tablets
`
`Alosetron Hydrochloride
`
`Tablets
`
`Alprazolam
`
`Alprazolam
`
`Ambrisentan
`
`Orally Disintegrating
`Tablets
`
`Tablets
`
`Tablets
`
`Amifostine
`Amlodipine Besylate
`
`For Injection
`Tablets
`
`Amlodipine Besylate and
`Atorvastatin Calcium
`
`Tablets
`
`Amlodipine Besylate and
`Atorvastatin Calcium
`Amlodipine Besylate and
`Atorvastatin Calcium*
`
`Tablets
`
`Tablets
`
`Amlodipine Besylate and
`Atorvastatin Calcium
`Amlodipine Besylate and
`Benazepril Hydrochloride
`
`Tablets
`
`Capsules
`
`Amlodipine Besylate and
`Benazepril Hydrochloride
`
`Capsules
`
`12/8/2005
`
`12/2/2010
`
`12/27/2005
`
`2/9/2015
`
`4/16/2004
`
`9/17/2009
`
`9/17/2009
`
`Uroxatral
`
`6/12/2007
`
`Tekturna
`
`12/13/2013
`
`Tekturna HCT 3/7/2014
`
`150 mg/12.5
`mg, 150 mg/25
`mg, 300
`
`mg/12.5 mg,
`300 mg/25 mg
`6.25 mg and
`12.5 mg
`0.5 mg and 1
`mg
`0.25 mg, 0.5
`mg, 1 mg and 2
`mg
`0.25 mg, 0.5
`mg, 1 mg and 2
`mg
`5 mg and 10 mg Letairis
`
`Axert
`
`Lotronex
`
`Niravam
`
`Xanax
`
`Ethyol
`Norvasc
`
`500 mg/vial
`2.5 mg, 5 mg
`and 10 mg
` 2.5 mg/10 mg,
`
`2.5 mg/20 mg
`and 10 mg/40
`mg
`2.5 mg/40 mg Caduet
`
`Caduet
`
`Caduet
`
`12/29/2006
`
`Caduet
`
`Lotrel
`
`4/7/2009
`
`6/9/2004
`
`Lotrel
`
`11/17/2006
`
`5 mg/10 mg, 5
`mg/20 mg, 5
`mg/40 mg, 10
`mg/10 mg, 10
`mg/20 mg and
`10 mg/80 mg
`5 mg/80 mg
`
`2.5 mg/10 mg, 5
`mg/10 mg, 5
`mg/20 mg and
`10 mg/20 mg
`5 mg/40 mg and
`10 mg/40 mg
`
`Page 2
`
`PAGE 2 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`Amlodipine Besylate and
`Olmesartan Medoxomil
`
`Amlodipine Besylate and
`Olmesartan Medoxomil
`
`Amlodipine Besylate and
`Valsartan
`Amlodipine Besylate and
`Valsartan
`Amlodipine Besylate and
`Valsartan
`Amlodipine Besylate and
`Valsartan
` Amlodipine,
`
`Hydrochlorothiazide and
`Valsartan!
`
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
` Amlodipine,
`
`Hydrochlorothiazide and
`Valsartan!
`Amoxicillin and Clavulanate
`Potassium
`Aprepitant
`
`Tablets
`
`Extended-release
`Tablets
`Capsule
`
`Arformoterol Tartrate
`
`Inhalation Solution
`
`Argatroban
`
`
`
` Argatroban in Sodium
`Chloride
`Aripiprazole
`Aripiprazole
`
`Injection
`
`Injection
`
`Oral Solution
`Tablets
`
`Aripiprazole
`
`
`
` Armodafinil
`
`
`
` Armodafinil
`
`Orally Disintegrating
`Tablets
`
`Tablets
`
`Tablets
`
`RLD
`
`Azor
`
` DATE OF
`
`SUBMISSION
`2/11/2008
`
`5 mg/20 mg and
`10 mg/40 mg
`
`10 mg/20 mg
`and 5 mg/40 mg
`
`Azor
`
`3/31/2008
`
`5 mg/160 mg
`
`Exforge
`
`10/22/2007
`
`5 mg/320 mg
`
`Exforge
`
`11/26/2007
`
`10 mg/160 mg Exforge
`
`10/1/2007
`
`10 mg/320 mg Exforge
`
`11/9/2007
`
`5 mg/12.5
`mg/160 mg, 5
`mg/25 mg/160
`mg, 10 mg/25
`mg/160 mg and
`10 mg/25
`mg/320 mg
`10 mg/12.5
`mg/160 mg
`
`1000 mg/62.5
`mg
`40 mg, 80 mg
`and 125 mg
`Eq. 0.015 mg
`base/2 mL
`100 mg/mL, 2.5
`mL vials
`1 mg/mL, 50 mL
`vials
`1 mg/mL
`2 mg, 5 mg, 10
`mg, 15 mg, 20
`mg and 30 mg
`
` 10 mg, 15 mg,
`20 mg and 30
`mg
`50 mg, 150 mg
`and 250 mg
`100 mg
`
`Exforge HCT
`
`9/14/2009
`
`Exforge HCT
`
`10/22/2009
`
`Augmentin XR 1/21/2009
`
`Emend
`
`11/3/2008
`
`Brovana
`
`10/1/2009
`
`Argatroban
`
`9/24/2007
`
`Argatroban
`
`12/16/2011
`
`Abilify
`Abilify
`
`12/20/2007
`11/15/2006
`
`Abilify
`
`11/15/2006
`
` Nuvigil
`
`7/24/2009
`
`Nuvigil
`
`9/8/2009
`
` Armodafinil
`
`Asenapine Maleate
`
`Tablets
`Sublingual Tablets
`
`Nuvigil
`200 mg
`5 mg and 10 mg Saphris
`
`9/3/2009
`8/13/2013
`
`Page 3
`
`PAGE 3 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Aspirin and Dipyridamole
`
`Atazanavir Sulfate
`
`Atazanavir Sulfate
`Atazanavir Sulfate
`Atenolol
`
`Extended-release
`Capsules
`Capsules
`
`Capsules
`Capsules
`Tablets
`
`Atenolol/ Chlorthalidone
`
`Tablets
`
`Atovaquone*
`Atovaquone and Proguanil
`Hydrochloride
`Atovaquone and Proguanil
`Hydrochloride
`Atomoxetine Hydrochloride Capsules
`
`Oral Suspension
`Tablets
`
`Tablets
`
`
`
`Atorvastatin Calcium
`
`Tablets
`
`Azelaic Acid
`
`Gel
`
`Aggrenox
`
`Reyataz
`
`25 mg and 200
`mg
`100 mg and 150
`mg
`200 mg
`300 mg
`25 mg, 50 mg
`and 100 mg
`50 mg/25 mg
`and 100 mg/25
`mg
`750 mg/5 mL Mepron
`62.5 mg/25 mg Malarone
`
`Reyataz
`Reyataz
`Tenormin
`
`Tenoretic
`
` DATE OF
`
`SUBMISSION
`2/1/2007
`
`3/19/2010
`
`2/16/2010
`7/20/2009
`
`10/20/2009
`9/14/2010
`
`250 mg/100 mg Malarone
`
`4/3/2009
`
`Strattera
`
`5/29/2007
`
`Lipitor
`
`Finacea
`
`7/27/2012
`
`
`
`10 mg, 18 mg,
`25 mg, 40 mg,
`60 mg, 80 mg
`and 100 mg
`10 mg, 20 mg,
`40 mg and 80
`mg
`15%
`
`Azelastine Hydrochloride
`
`Nasal Spray
`
`Azelastine Hydrochloride
`
`Nasal Spray
`
`0.125 mg
`base/spray
`205.5 mcg/spray Astepro
`
`Astelin
`
`Azelastine Hydrochloride
`Azelastine Hydrochloride
`and Fluticasone Propionate
`
`Ophthalmic Solution 0.05%
`Nasal Spray
`137 mcg/50
`mcg per spray
`
`Optivar
`Dymista
`
`11/14/2005
`
`12/15/2011
`
`12/13/2006
`6/13/2014
`
`Azithromycin
`Azithromycin
`Balsalazide Disodium
`
`500 mg/vial
`for Injection
`Ophthalmic Solution 1%
`Tablets
`1.1 g
`
`Zithromax
`Azasite
`Giazo
`
`6/17/2011
`3/3/2011
`11/5/2013
`
`Bendamustine
`Hydrochloride
`
`Bendamustine
`Hydrochloride
`
`Injection
`
`Injection
`
`25 mg/vial and
`100 mg/vial
`
`90 mg/mL, 0.5
`mL and 2 mL in
`single-dose vials
`
`Treanda
`
`6/4/2013
`
`Treanda
`
`6/19/2014
`
`Bepotastine Besilate
`
`Ophthalmic Solution 1.5%
`
`Bepreve
`
`9/9/2013
`
`Betamethasone Valerate
`
`Foam
`
`0.12%
`
`Luxiq
`
`8/10/2007
`
`Page 4
`
`PAGE 4 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Betaxolol
`Bexarotene
`Bimatoprost
`Bimatoprost
`Bimatoprost
`Bivalirudin
`Brimonidine
`Bortezomib*
`Brimonidine Tartrate
`Brimonidine Tartrate
`
`Ophthalmic Solution 0.5%(base)
`Capsules
`75 mg
`Ophthalmic Solution 0.01%
`Ophthalmic Solution 0.03%
`Topical Solution
`0.03%
`For Injection
`250 mg/vial
`Topical Gel
`0.33%
`For Injection
`3.5 mg/vial
`Ophthalmic Solution 0.1%
`Ophthalmic Solution 0.15%
`
`Betoptic
`Targretin
`Lumigan
`Lumigan
`Latisse
`Angiomax
`Mirvaso
`Velcade
`Alphagan P
`Alphagan P
`
` DATE OF
`
`SUBMISSION
`
`6/6/2011
`4/5/2011
`12/22/2008
`5/3/2010
`9/1/2009
`12/15/2014
`11/20/2008
`12/20/2006
`11/03/2006
`
`Brimonidine Tartrate
`Brimonidine Tartrate and
`Timolol Maleate
`Bromfenac Sodium
`
`Ophthalmic Solution 0.2%
`Ophthalmic Solution 0.2%/0.5%
`
`Alphagan
`Combigan
`
`11/21/2008
`
`Ophthalmic Solution 0.07%
`
`Prolensa
`
`7/26/2013
`
`3 mg
`
`Entocort EC
`
`2/1/2008
`
`Enteric Coated
`Capsules
`Nasal Spray
`
`0.032 mg (32
`mcg)/spray
`Inhalation Suspension 0.25 mg/2 mL
`and 0.5 mg/2
`mL
`Inhalation Suspension 1 mg/2 mL
`
`Rhinocort
`
`5/14/2007
`
`9/15/2005
`
`5/28/2010
`
`3/11/2013
`
`Pulmicort
`Respules
`
`Pulmicort
`Respules
`Uceris
`
`
`
`Extended-release
`Tablets
`
`Sublingual Film
`
`9 mg
`
`2 mg/0.5 mg
`and 8 mg/2 mg
`
`Suboxone
`
`10/15/2012
`
`Sublingual Film
`
`4 mg/1 mg
`
`Suboxone
`
`5/14/2013
`
`Sulingual Film
`
`12 mg/3 mg
`
`Suboxone
`
`3/26/2014
`
`Sublingual Tablets
`
`Sublingual Tablets
`
`1.4 mg/0.36 mg
`and 5.7 mg/1.4
`mg
`
`8.6 mg/2.1 mg
`and 11.4 mg/2.9
`mg
`
`Zubsolv
`
`10/22/2013
`
`Zubsolv
`
`7/24/2015
`
`Page 5
`
`Budesonide
`
`Budesonide
`
`Budesonide
`
`Budesonide
`
`Budesonide
`
`Buprenorphine
`Hydrochloride and Naloxone
`Hydrochloride
`
`Buprenorphine
`Hydrochloride and Naloxone
`Hydrochloride
`
`Buprenorphine
`Hydrochloride and Naloxone
`Hydrochloride
`
`Buprenorphine
`Hydrochloride and Naloxone
`Hydrochloride Dihydrate
`
`Buprenorphine
`Hydrochloride and Naloxone
`Hydrochloride Dihydrate
`NEW
`
`PAGE 5 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`Buprenorphine
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Transdermal System 5 mcg/hr, 10
`mcg/hr, and 20
`mcg/hr
`
`Butrans
`
` DATE OF
`
`SUBMISSION
`6/6/2013
`
`Buprenorphine
`
`Transdermal System 15 mcg/hr
`
`Butrans
`
`12/16/2013
`
`Bupropion Hydrobromide
`
`Bupropion Hydrobromide
`
`Bupropion Hydrobromide
`
`Bupropion Hydrochloride
`
`Bupropion Hydrochloride
`
`Bupropion Hydrochloride
`
`Bupropion Hydrochloride
`
`Bupropion Hydrochloride
`
`Extended-release
`Tablets
`Extended-release
`Tablets
`Extended-release
`Tablets
`Extended-release
`Tablets
`Extended-release
`Tablets
`Extended-release
`Tablets
`Extended-release
`Tablets
`Tablets
`
`Buspirone Hydrochloride
`
`Tablets
`
`174 mg
`
`348 mg
`
`522 mg
`
`Aplenzin
`
`9/28/2009
`
`Aplenzin
`
`9/24/2009
`
`Aplenzin
`
`12/24/2009
`
`100 mg, 150 mg
`and 200 mg
`150 mg
`
`150 mg and 300
`mg
`450 mg
`
`75 mg and 100
`mg
` 5 mg, 7.5 mg,
`
`10 mg, 15 mg
`and 30 mg
`
`W ellbutrin SR
`
`Zyban
`
`W ellbutrin XL 9/21/2004
`
`Forfivo XL
`
`2/28/2013
`
`W ellbutrin
`
`Buspar
`
`Busulfan
`
`Injection
`
`6 mg/mL
`
`Busulfex
`
`12/26/2012
`
`Butoconazole Nitrate
`
`Vaginal Cream
`
`2% Gynazole-1
`
`12/23/2009
`
`Butorphanol Tartrate
`Cabazitaxel
`
`Nasal Spray
`Injection
`
`10 mg/mL
`60 mg/1.5 mL
`
`Stadol NS
`Jevtana
`
`6/17/2014
`
`Topical Cream
`Topical Solution
`Ointment
`
`Dovonex
`0.005%
`Dovonex
`0.005%
`0.005%/0.064% Taclonex
`
`12/2/2009
`5/19/2006
`3/31/2010
`
`200 IU/spray
`200 IU/spray
`
`Miacalcin
`Fortical
`
`3/29/2006
`
`Calcijex
`
`PhosLo
`
`5/31/2005
`
`1 mcg/mL and 2
`mcg/mL, 1 mL
`vials
`EQ 169 mg
`calcium
`
`Page 6
`
`Calcipotriene
`Calcipotriene
`Calcipotriene and
`Betamethasone
`Dipropionate
`Calcitonin-Salmon
`Calcitonin-Salmon
`(Recombinant)
`Calcitriol
`
`Nasal Spray
`Nasal Spray
`
`Injection
`
`Calcium Acetate
`
`Capsules
`
`PAGE 6 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Calcium Acetate
`
`Oral Solution
`
`667 mg/5 mL
`
`Phoslyra
`
` DATE OF
`
`SUBMISSION
`12/5/2013
`
`Chewable Tablets
`
` 800 mg/ 10 mg/
`
`165 mg (OTC)
`
`Pepcid
`Complete
`
`11/1/2004
`
`Atacand
`
`12/22/2006
`
`Atacand HCT 6/25/2008
`
`Atacand HCT 3/6/2009
`
`Xeloda
`
`11/10/2008
`
`Capoten
`
`Carbatrol
`
`2/2/2006
`
`Equetro
`
`Equetro
`
`8/21/2007
`
`5/23/2014
`
`Carbatrol
`
`Tegretol-XR
`
`12/30/2005
`
`Tegretol-XR
`
`Stalevo 50
`
`8/5/2008
`
`Stalevo 75 and
`Stalevo 125
`
`5/19/2009
`
`6/29/2007
`
`Stalevo 100
`and Stalevo
`150
`
`Stalevo 200
`
`8/28/2008
`
`Sinemet CR
`
`Rytary
`
`6/10/2015
`
`4 mg, 8 mg, 16
`mg and 32 mg
`16 mg/12.5 mg
`and 32 mg/12.5
`mg
`32 mg/25 mg
`
`150 mg and 500
`mg
` 12.5 mg, 25 mg,
`
`50 mg, and 100
`mg
`100 mg and 200
`mg
`200 mg and 300
`mg
`100 mg
`
`300 mg
`
`100 mg
`
`200 mg and 400
`mg
`12.5 mg, 50 mg
`and 200 mg
`18.75 mg/75
`mg/200 mg and
`31.25 mg/125
`mg/200 mg
`25/100/200 mg
`and
`37.5/150/200
`mg
`50 mg/200
`mg/200 mg
`25 mg/100 mg
`and 50 mg/200
`mg
`61.25 mg/245
`mg
`
`Page 7
`
`
`
` Calcium Carbonate/
`
` Famotadine/ Magnesium
`Hydroxide
`Candesartan Cilexetil
`
`Candesartan Cilexetil and
`Hydrochlorothiazide
`
`Candesartan Cilexetil and
`Hydrochlorothiazide
`Capecitabine
`
`Captopril
`
`Carbamazepine
`
`Carbamazepine
`
`Carbamazepine
`
`Carbamazepine
`
`Carbamazepine
`
`Carbamazepine
`
`Carbidopa, Levodopa and
`Entacapone
`Carbidopa, Levodopa and
`Entacapone
`
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
`Extended-release
`Capsules
`Extended-release
`Capsules
`Extended-release
`Capsules
`
`Extended-release
`Capsules
`Extended-release
`Tablets
`Extended-release
`Tablets
`Tablets
`
`Tablets
`
`Carbidopa, Levodopa and
`Entacapone
`
`Tablets
`
`Carbidopa, Levodopa and
`Entacapone
`Carbidopa/ Levodopa
`
`Carbidopa and Levodopa
`
`Tablets
`
`Extended-release
`Tablets
`
`Extended-release
`Capsules
`
`PAGE 7 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`DRUG NAME
`
`Carboplatin
`
`For Injection
`
`Carboplatin
`
`Injection
`
`Carisoprodol/ Aspirin
`
`
`
` Carisoprodol/ Aspirin/
`Codeine
`
`Carvedilol
`
`Tablets
`
`Tablets
`
`Tablets
`
`Carvedilol Phosphate
`
`Carvedilol Phosphate
`
`Carvedilol Phosphate
`
`Caspofungin Acetate
`
`Extended-release
`Capsules
`Extended-release
`Capsules
`Extended-release
`Capsules
`For Injection
`
`Ceftaroline Fosamil
`
`For Injection
`
` DATE OF
`
`SUBMISSION
`
`Paraplatin
`
`Paraplatin
`
`50 mg/vial, 150
`mg/vial and 450
`mg/vial
`50 mg/vial, 150
`mg/vial and 450
`mg/vial
`200 mg/ 325 mg Soma
`Compound
`Soma
`Compound
`with Codeine
`Coreg
`
`200 mg/ 325
`mg/ 16 mg
`
`3.125 mg, 6.25
`mg, 12.5 mg
`and 25 mg
`10 mg and 20
`mg
`40 mg
`
`Coreg CR
`
`3/18/2008
`
`Coreg CR
`
`12/21/2007
`
`80 mg
`
`Coreg CR
`
`11/19/2007
`
`50 mg/vial and
`70 mg/vial
`400 mg/vial and
`600 mg/vial
`
`Cancidas
`
`6/26/2009
`
`Teflaro
`
`10/29/2014
`
`Celecoxib*
`Celecoxib
`
`Capsules
`Capsules
`
`Cetirizine Hydrochloride
`Cetirizine Hydrochloride
`
`Syrup
`Chewable Tablets
`
`Celebrex
`Celebrex
`
`50 mg
`100 mg, 200 mg
`and 400 mg
`Zyrtec
`5 mg/5 mL
`5 mg and 10 mg Zyrtec
`
`3/21/2008
`
`3/19/2007
`3/25/2005
`
`Extended-release
`Cetirizine Hydrochloride and
`Tablets
`Pseudoephedrine
`30 mg
`Cevimeline Hydrochloride Capsules
`Chlorhexidine Gluconate
`Scrub brush/sponge 4%
` Chlorpheniramine Polistirex
`
`Extended-release
`8 mg/10 mg and
`and Hydrocodone Polistirex
`Capsules
`4 mg/5 mg
`
`5 mg/120 mg
`
`Zyrtec-D
`
`6/2/2004
`
`Evoxac
`Hibiclens
`Tussionex
`
`2/27/2009
`
`9/10/2004
`
`Ciclesonide
`Ciclopirox
`
`Nasal Spray
`Gel
`
`50 mcg
`0.77%
`
`Omnaris
`Loprox
`
`2/13/2012
`5/10/2006
`
`Cinacalcet Hydrochloride
`
`Tablets
`
`Ciprofloxacin
`
`Oral Suspension
`
`Ciprofloxacin Hydrochloride Tablets
`
`Sensipar
`
`3/10/2008
`
`Cipro
`
`10/16/2009
`
`Cipro
`
`30 mg, 60 mg
`and 90 mg
`250 mg/5 mL
`and 500 mg/ 5
`mL
`100 mg, 250
`mg, 500 mg and
`750 mg
`
`Page 8
`
`PAGE 8 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Ciprofloxacin and
`Dexamethasone
`
`Otic Suspension
`
`0.3%/0.1%
`
`Ciprodex
`
` DATE OF
`
`SUBMISSION
`7/31/2012
`
`Cisatracurium Besylate
`(multi-dose)
`
`Cisatracurium Besylate
`
` (preserve free)
`
`Injection
`
`Injection
`
`Cisplatin
`
`Injection
`
`Cisplatin
`
`Clarithromycin
`
`For Injection
`
`Extended-release
`Tablets
`
`Clindamycin Phosphate
`
`Foam
`
`Clindamycin Phosphate
`
`Vaginal Cream
`
`Clindamycin Phosphate and
`Benzoyl Peroxide
`Clindamycin Phosphate and
`Tretinoin
`Clindamycin Phosphate and
`Benzoyl Peroxide
`
`Gel
`
`Gel
`
`Gel
`
`2 mg/mL, 10 mL
`vial
`2 mg/mL, 5 mL
`vial and 10
`mg/mL, 20 mL
`vial
`1 mg/mL, 10
`mL, 50 mL, 100
`mL and 200 mL
`vials
`10 mg/vial and
`50 mg/vial
`500 mg
`
`1%
`
`2%
`
`Nimbex
`
`Nimbex
`
`8/12/2009
`
`8/4/2009
`
`Platinol-AQ
`
`Platinol
`
`Biaxin XL
`
`Evoclin
`
`PIV received
`prior to 2/5/2009
`
`PIV received
`prior to 2/5/2009
`
`Clindesse
`
`2/5/2015
`
`1% / 5%
`
`Duac
`
`12/11/2008
`
`1.2%/0.025%
`
`Ziana
`
`12/17/2010
`
`1.2%/2.5%
`
`Acanya
`
`12/20/2012
`
`Clobetasol Propionate
`Clobetasol Propionate
`Clobetasol Propionate
`Clobetasol Propionate
`Clobetasol Propionate
`Clofarabine
`
`Clonidine Hydrochloride
`
`Clonidine Hydrochloride
`
`Clonidine Hydrochloride
`
`Clopidogrel Bisulfate
`Clopidogrel Bisulfate
`Clozapine
`
`Emulsion Foam
`Topical Foam
`Lotion
`Spray
`Topical Shampoo
`Injection
`
`0.05% Olux-E
`Olux
`Clobex
`Clobex
`Clobex
`Clolar
`
`2/25/2010
`6/27/2005
`3/27/2006
`9/29/2008
`1/9/2008
`2/23/2012
`
`3/4/2011
`
`3/4/2011
`
`Jenloga
`
`Kapvay
`
`Catapres-TTS
`
`Plavix
`Plavix
`Fazaclo
`
`3/4/2009
`6/5/2008
`
`0.05%
`0.05%
`0.05%
`0.05%
`1 mg/mL, 20 mL
`vial
`0.1 mg and 0.2
`Extended-release
`mg
`Tablets
`0.1 mg and 0.2
`Extended-release
`mg
`Tablets
`Transdermal System 0.1 mg/day, 0.2
`mg/day, and 0.3
`mg/day
`75 mg
`300 mg
`12.5 mg
`
`Tablets
`Tablets
`Orally Disintegrating
`Tablets
`
`Page 9
`
`PAGE 9 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Clozapine
`
`Clozapine
`
`Clozapine
`
`Orally Disintegrating
`Tablets
`Orally Disintegrating
`Tablets
`Orally Disintegrating
`Tablets
`Tablets
`Colchicine
` Colesevelam Hydrochloride Powder for Oral
`Suspension
`Colesevelam Hydrochloride Tablets
`
`
`
`Colestipol Hydrochloride
`Conjugated Estrogen
`(Synthetic A)
`Conjugated Estrogen
`(Synthetic A)
`Conjugated Estrogen
`(Synthetic A)
`
`Conjugated Estrogens
`
`Cyclobenzaprine
`Hydrochloride
`Cyclobenzaprine
`Hydrochloride
`Cyclophosphamide
`
`Tablets
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
`Tablets
`
`Extended-release
`Capsule
`For Injection
`
`Dabigatran Etexilate
`Mesylate
`
`Capsules
`
`Dalfampridine
`
`Extended-release
`Tablets
`
`For Injection
`Daptomycin
`Darifenacin Hydrobromide Extended-release
`Tablets
`Tablets
`
`Darunavir Ethanolate
`
`25 mg and 100
`mg
`150 mg
`
`Fazaclo
`
`Fazaclo
`
` DATE OF
`
`SUBMISSION
`4/28/2008
`
`4/8/2011
`
`200 mg
`
`Fazaclo
`
`4/18/2011
`
`
`
`0.6 mg
` 1.875 g/Packet
`and 3.75
`/P
`
`625 mg
`
`1 g
`0.3 mg, 0.45 mg
`and 0.9 mg
`1.25 mg
`
`Colcrys
`W elchol
`
`12/23/2011
`4/9/2010
`
`W elchol
`
` 7/1/2009
`
`Colestid
`Cenestin
`
`8/23/2005
`3/19/2009
`
`Cenestin
`
`11/3/2008
`
`0.625 mg
`
`Cenestin
`
`3/2/2009
`
`0.3 mg and
`0.625 mg
`10 mg
`
`15 mg and 30
`mg
`100 mg/vial, 200
`mg/vial, 500
`mg/vial, 1 g/vial
`
`and 2 g/vial
`
`eq. to 75 mg
`base and 150
`mg base
`
`Premarin
`
`Flexeril
`
`Amrix
`
`Cytoxan
`
`8/11/2008
`
`Pradaxa
`
`10/20/2014
`
`10 mg
`
`Ampyra
`
`1/22/2014
`
`500 mg/vial
`7.5 mg and 15
`mg
` 75 mg, 150 mg,
`
`300 mg, 400 mg
`and 600 mg
`
`Cubicin
`Enablex
`
`11/19/2008
`12/22/2008
`
`Prezista
`
`6/23/2010
`
`Darunavir Ethanolate
`
`Tablets
`
`800 mg
`
`Prezista
`
`5/14/2013
`
`Dasatinib
`
`Tablets
`
`80 mg and 140
`mg
`
`Sprycel
`
`6/17/2011
`
`Page 10
`
`PAGE 10 OF 52
`
`

`
`DRUG NAME
`
`Dasatinib
`
`Deferasirox
`
`Desflurane
`Desloratadine
`Desloratadine
`
`Desloratadine
`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Tablets
`
`Tablets
`
` 20 mg, 50 mg,
`
`70 mg and 100
`mg
`125 mg, 250
`mg, and 500 mg
`
`Sprycel
`
` DATE OF
`
`SUBMISSION
`6/28/2010
`
`Exjade
`
`10/28/2011
`
`Inhalation
`Tablets
`Orally Disintegrating
`Tablets
`Oral Solution
`
`99.9%
`5 mg
`2.5 mg and 5
`mg
`0.5 mg/mL
`
`Suprane
`Clarinex
`Clarinex
`
`9/11/2008
`6/21/2006
`6/21/2006
`
`Clarinex Syrup 5/8/2008
`
`Desloratadine and
`Pseudoephedrine Sulfate
`Desloratadine and
`Pseudoephedrine Sulfate
`Desmopressin Acetate
`
`Extended-release
`Tablets
`Extended-release
`Tablets
`Injection
`
`2.5 mg/120 mg Clarinex-D 24
`Hour
`Clarinex-D 24
`Hour
`DDAVP
`
`5 mg/240 mg
`
`4 mcg/mL, 1 mL
`and 10 mL vials
`
`6/1/2007
`
`6/21/2006
`
`Desmopressin Acetate
`Desmopressin Acetate
`
`Nasal Spray
`Tablets
`
` Desogestrel; Ethinyl
`
`Estradiol Tablets
`
`Tablets
`
`0.01%
`0.1 mg and 0.2
`mg
` 0.15mg/ 0.02
`
`mg and 0.01 mg
`
`DDAVP
`DDAVP
`
`Mircette
`
`Desonide
`Desoximetasone
`
`Gel
`Topical Spray
`
`0.05%
`0.25%
`
`Desonate
`Topicort
`
`12/1/2010
`12/18/2013
`
`Dexlansoprazole
`
`Dexlansoprazole
`
`Desvenlafaxine Succinate Extended-release
`Tablets
`Delayed-release
`Capsules
`Delayed-release
`Capsules
`Injection
`Injection
`
`Dexmedetomidine
`Dexmedetomidine
`
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`Hydrochloride
`
`Tablets
`
`Tablets
`
`Extended-release
`Capsules
`Extended-release
`Capsules
`Extended-release
`Capsules
`
`50 mg and 100
`mg
`30 mg
`
`Pristiq
`
`2/29/2012
`
`Dexilant
`
`11/30/2010
`
`60 mg
`
`Dexilant
`
`8/25/2010
`
`100 mcg/mL
`4 mcg/mL, 50
`mL and 100 mL
`vials
`2.5 mg
`
`Precedex
`Precedex
`
`4/8/2009
`12/26/2013
`
`Focalin
`
`7/27/2004
`
`5 mg and 10 mg Focalin
`
`5/27/2004
`
`15 mg
`
`Focalin XR
`
`5/14/2007
`
`5 mg, 10 mg
`and 20 mg
`30 mg
`
`Focalin XR
`
`3/30/2007
`
`Focalin XR
`
`12/15/2010
`
`Page 11
`
`PAGE 11 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Dexmethylphenidate
`Hydrochloride
`Dexmethylphenidate
`
`Dexmethylphenidate
`
`Dexrazoxane
`
`Extended-release
`Capsules
`Extended-release
`Capsules
`Extended-release
`Capsules
`For Injection
`
`40 mg
`
`35 mg
`
`25 mg
`
`Focalin XR
`
` DATE OF
`
`SUBMISSION
`12/20/2010
`
`Focalin XR
`
`9/29/2011
`
`Focalin XR
`
`9/30/2011
`
`Extended-release
`Capsules
`
`Tablets
`
`Tablets
`
`Dextroamphetamine
`saccharate; Amphetamine
`aspartate;
`
`Dextroamphetamine
`Sulfate; Amphetamine
`Sulfate
`Dextroamphetamine
`saccharate; Amphetamine
`aspartate;
`
`Dextroamphetamine
`Sulfate; Amphetamine
`Sulfate
`Dextroamphetamine
`saccharate; Amphetamine
`aspartate;
`
`Dextroamphetamine
`Sulfate; Amphetamine
`Sulfate
`Dextromethorphan Polistirex Extended-release
`Suspension
`Capsules
`
`Dextromethorphan
`Hydrobromide and
`Quinidine Sulfate
`Diazepam
`
`Diazepam
`
`Tablets
`
`Rectal Gel
`
`Diazepam
`
`Rectal Gel
`
`Diazepam
`
`Rectal Gel
`
`250 mg/vial
`
`Zinecard
`
`5 mg, 10 mg, 15
`mg, 20 mg, 25
`mg and 30 mg
`
`Adderall XR
`
`5 mg, 10 mg, 20
`mg, 30 mg
`
`
`
` Adderall
`
`11/18/2009
`
`7.5 mg, 12.5 mg
`and 15 mg
`
`Adderall
`
`30 mg/5 mL
`
`Delsym
`
`1/12/2009
`
`20 mg/10 mg
`
`Nuedexta
`
`3/7/2011
`
`
`
`2 mg, 5 mg and
`10 mg
` 2.5 mg/0.5 mL,
`5 mg/mL, 10
`mg/2 mL, 15
`mg/3 mL and 20
`mg/4 mL
`5 mg/mL, 4mL
`pre-filled syringe
`
`5 mg/mL, 2mL
`pre-filled syringe
`
`Valium
`
`Diastat
`
`3/23/2004
`
`Diastat Acudial 12/8/2008
`
`Diastat Acudial 12/23/2008
`
`
`
` Diclofenac Potassium
`
`Oral Solution (Sachet) 50 mg
`
`Cambia
`
`1/24/2011
`
`Diclofenac Potassium
`Diclofenac Sodium
`
`Capsules
`Topical Gel
`
`25 mg
`
`Zipsor
`3% Solaraze
`
`11/14/2012
`12/16/2009
`
`Page 12
`
`PAGE 12 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Diclofenac Sodium
`Diclofenac Sodium
`
`Topical Solution
`Topical Solution
`
`1.5% Pennsaid
`2.0% Pennsaid
`
` DATE OF
`
`SUBMISSION
`7/11/2012
`6/3/2014
`
`18 mg and 35
`mg
`
`Zorvolex
`
`6/6/2014
`
`50 mg/0.2 mg
`
`Arthrotec
`
`6/29/2009
`
`75 mg/0.2 mg
`
`Arthrotec
`
`11/28/2008
`
`Diclofenac
`
`Capsules
`
`Diclofenac Sodium and
`Misoprostol*
`
`Delayed-release
`Tablets
`
`Diclofenac Sodium and
`Misoprostol*
`Didanosine
`
`Diltiazem Hydrochloride
`
`Diltiazem Hydrochloride
`
`Diltiazem Hydrochloride
`
`Delayed-release
`Tablets
`Delayed-release
`Capsules
`Extended-release
`Capsules
`Extended-release
`Capsules
`Extended-release
`Capsules
`
`Diltiazem Hydrochloride
`
`Extended-release
`Capsules
`
`Diltiazem Hydrochloride
`
`Extended-release
`Tablets
`
`200 mg, 250 mg
`and 400 mg
`
` 60 mg, 90 mg
`and 120 mg
`120 mg, 180 mg
`and 240 mg
`120 mg, 180
`
` mg, 240 mg,
`300 mg and 360
`mg
`120 mg, 180
`mg, 240 mg,
`
`300 mg, 360 mg
`and 420 mg
`120 mg, 180
`mg, 240 mg,
`
`300 mg and 360
`mg
`420 mg
`
`Videx EC
`
`6/1/2004
`
`Cardizem SR
`
`Dilacor XR
`
`Cardizem CD
`
`Tiazac
`
`Cardizem LA
`
`8/30/2005
`
`Cardizem LA
`
`4/25/2005
`
`Durezol
`
`5/1/2014
`
`Diltiazem Hydrochloride
`
`Difluprednate
`
`Extended-release
`Tablets
`Ophthalmic Emulsion 0.05%
`
`Divalproex Sodium
`
`Divalproex Sodium*
`
`Divalproex Sodium
`
`Docetaxel
`
`Delayed-release
`Tablets
`Extended-release
`Tablets
`Extended-release
`Tablets
`Injection
`
`Dofetilide
`
`Capsules
`
`Donepezil Hydrochloride
`
`Tablets
`
`125 mg, 250 mg
`and 500 mg
`250 mg
`
`Depakote
`
`Depakote ER 5/3/2004
`
`500 mg
`
`Depakote ER 2/8/2005
`
`Taxotere
`
`40 mg/mL, 0.5
`mL and 2 mL
`
` vials
`0.125 mg, 0.25
`mg, and 0.5 mg
`5 mg and 10 mg Aricept
`
`Tikosyn
`
`6/30/2009
`
`5/1/2014
`
`Donepezil Hydrochloride
`
`Orally Disintegrating
`Tablets
`
`5 mg and 10 mg Aricept ODT
`
`6/30/2010
`
`Page 13
`
`PAGE 13 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Donepezil Hydrochloride
`Doripenem
`
`Tablets
`Injection
`
`23 mg
`250 mg/vial and
`500 mg/vial
`
`Aricept
`Doribax
`
` DATE OF
`
`SUBMISSION
`7/9/2013
`10/12/2011
`
`Dorzolamide Hydrochloride Ophthalmic Solution 2%
`
`Dorzolamide Hydrochloride
`and Timolol Maleate
`
`Ophthalmic Solution 2%/0.5%
`
`Trusopt
`
`Cosopt
`
`10/11/2005
`
`10/11/2005
`
`Cardura
`
`9/16/2010
`2/12/2010
`3/25/2009
`
`10/15/2007
`
`12/28/2011
`
`12/11/2008
`
`75 mg and 100
`mg
`150 mg
`
`200 mg
`
`Doryx
`
`Doryx
`
`Doryx
`
`PIV received
`prior to 2/5/2009
`12/19/2008
`
`5/19/2014
`
`80 mg
`
`Doryx
`
`7/1/2015
`
`Doxylamine Succinate and
`Pyridoxine Hydrochloride
`
`Delayed-release
`Tablets
`
`10 mg/10 mg
`
`Diclegis
`
`8/1/2013
`
`Dronedarone Hydrochloride Tablets
`
`400 mg
`
`Multaq
`
`7/1/2013
`
`Drospirenone and Estradiol Tablets
`
`0.5 mg/1 mg
`
`Angeliq
`
`12/26/2007
`
`3 mg/0.02 mg
`
`Yaz
`
`9/29/2006
`
`3 mg/0.03 mg
`
`Yasmin
`
`1/7/2005
`
`3 mg/0.03
`mg/0.451 mg
`and 0.451 mg
`
`Safyral
`
`9/28/2012
`
`Tablets
`
`Tablets
`
`Tablets
`
`
`
`Drospirenone and Ethinyl
`Estradiol
`Drospirenone and Ethinyl
`Estradiol
`Drospirenone and Ethinyl
`Estradiol and Levomefolate
`Calcium and Levomefolate
`Calcium
`
`Page 14
`
`1 mg, 2 mg, 4
`mg and 8 mg
`3 mg and 6 mg Silenor
`1 mcg
`Hectorol
`0.5 mcg and 2.5
`Hectorol
`mcg
`2 mcg/mL, 2 mL
`ampules
`2 mcg/mL, 1 mL
`in 2 mL vial
`
`40 mg
`
`Hectorol
`
`Hectorol
`
`Oracea
`
`Doxazosin Mesylate
`
`Tablets
`
`Doxepin Hydrochloride
`Doxercalciferol
`Doxercalciferol
`
`Doxercalciferol*
`
`Doxercalciferol*
`
`Doxycycline
`
`Doxycycline Hyclate
`
`Doxycycline Hyclate
`
`Doxycycline Hyclate
`
`Doxycycline Hyclate
`
`Tablets
`Capsules
`Capsules
`
`Injection
`
`Injection
`
`Delayed-release
`Capsules
`Delayed-release
`Tablets
`Delayed-release
`Tablets
`Delayed-release
`Tablets
`
`Delayed-release
`Tablets
`
`PAGE 14 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Tablets
`
` Drospirenone and Ethinyl
`
`Estradiol and Levomefolate
`Calcium and Levomefolate
`
` Calcium
`Drospirenone and Estradiol Tablets
`
`Duloxetine Hydrochloride
`
`Duloxetine Hydrochloride
`
`Delayed-release
`Capsules
`Delayed-release
`Capsules
`
` DATE OF
`
`SUBMISSION
`11/13/2012
`
`3 mg/0.02
`mg/0.451 mg
`and 0.451 mg
`
`Beyaz
`
`0.25 mg/0.5 mg Angeliq
`
`1/8/2015
`
`20 mg, 30 mg
`and 60 mg
`40 mg
`
`Cymbalta
`
`8/4/2008
`
`Cymbalta
`
`5/10/2012
`
`Dutasteride
`
`Capsules
`
`0.5 mg
`
`Avodart
`
`10/29/2007
`
`Dutasteride and Tamsulosin
`Hydrochloride
`
`Capsules
`
`0.5 mg/0.4 mg
`
`Jalyn
`
`10/26/2010
`
`Efavirenz
`
`Efavirenz, Emtricitabine and
`
` Tenofovir Disoproxil
`Fumarate
`
`Tablets
`
`Tablets
`
`Eletriptan Hydrobromide
`
`Tablets
`
`Eltrombopag Olamine
`
`Tablets
`
`Eltrombopag Olamine
`
`Tablets
`
`
`
` Emtricitabine and Tenofovir
`Disoproxil Fumarate
`
`Tablets
`
`
` Emtricitabine, Rilpivirine,
`
` and Tenofovir Disoproxil
`Fumarate
`
`Tablets
`
`Enalapril Maleate
`
`Tablets
`
`600 mg
`
`Sustiva
`
`4/9/2009
`
`600 mg/200
`mg/300 mg
`
`Atripla
`
`12/29/2008
`
`Relpax
`
`20 mg and 40
`mg
`50 mg and 75
`mg
`12.5 mg and 25
`mg
`200 mg/300 mg Truvada
`
`Promacta
`
`Promacta
`
`3/29/2010
`
`1/7/2014
`
`2/4/2014
`
`9/26/2008
`
`200 mg/25
`mg/300 mg
`
`Complera
`
`5/20/2015
`
` 2.5 mg, 5 mg,
`
`10 mg and 20
`mg
`
`Vasotec
`
`Page 15
`
`PAGE 15 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Enoxaparin Sodium
`
`Injection
`
`Enoxaparin Sodium
`
`Injection
`
`Lovenox
`
`Lovenox
`
`100 mg/mL, 0.3
`mL, 0.4 mL, 0.6
`mL, 0.8 mL and
`1 mL prefilled
`syringes
`
`150 mg/mL, 0.6
`mL, 0.8 mL and
`1 mL prefilled
`syringes
`
` DATE OF
`
`SUBMISSION
`
`Injection
`
`Tablets
`Tablets
`
`Tablets
`
`Injection
`
`Injection
`
`Injection
`
`Enoxaparin Sodium
`
`Entacapone
`
` Entecavir
`
`Epinastine Hydrochloride
`Epinephrine
`
`Eplerenone
`
`Eptifibatide
`
`Eptifibatide
`
`Eptifibatide
`
`Eprosartan Mesylate
`
`Erlotinib Hydrochloride
`
`Ertapenem*
`Escitalopram Oxalate
`Escitalopram Oxalate
`
`100 mg/mL, 3
`mL vials
`200 mg
`0.5 mg and 1
`mg
`Ophthalmic Solution 0.05%
`Injection (Auto­
`0.15 mg/0.3 mL
`injector)
`and 0.3 mg/0.3
`mL
`25 mg and 50
`mg
` 0.75 mg/mL,
`
`100 mL vial
`2 mg/mL, 10 mL
`vial
`2 mg/mL, 100
`mL vial
`400 mg and 600
`mg
`25 mg, 100 mg
`and 150 mg
`1 g/vial
`5 mg
`10 mg and 20
`mg
`
`Tablets
`
`Tablets
`
`Injection
`Capsules
`Capsules
`
`Escitalopram Oxalate
`
`Tablets
`
`Esmolol Hydrochloride
`
`Injection
`
`Esmolol Hydrochloride
`
`Injection
`
`Esomeprazole Magnesium Delayed-release
`Capsules
`
`5 mg, 10 mg
`and 20 mg
`10 mg/mL, 10
`mL vial
`10 mg/mL, 250
`mL infusion
`bags and 20
`mg/mL, 100 mL
`infusion bags
`20 mg and 40
`mg
`
`Page 16
`
`Lovenox
`
`12/7/2006
`
`Comtan
`Baraclude
`
`4/11/2007
`6/14/2010
`
`Elestat
`Epipen and
`Epipen Jr.
`
`10/14/2008
`7/20/2009
`
`Inspra
`
`9/27/2006
`
`Integrilin
`
`6/5/2009
`
`Integrilin
`
`9/30/2008
`
`Integrilin
`
`12/18/2008
`
`Teveten
`
`5/10/2010
`
`Tarceva
`
`11/18/2008
`
`12/21/2012
`8/17/2005
`3/30/2005
`
`Invanz
`Lexapro
`Lexapro
`
`Lexapro
`
`Brevibloc
`
`Brevibloc
`
`1/31/2014
`
`Nexium
`
`8/5/2005
`
`PAGE 16 OF 52
`
`

`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DRUG NAME
`
`DOSAGE FORM
`
`STRENGTH
`
`Esomeprazole Magnesium Delayed-release
`Capsules
`
`20 mg
`
`RLD
`
` DATE OF
`
`SUBMISSION
`Nexium (OTC) 4/24/2014
`
`Esomeprazole Sodium
`
`
`
` Estradiol
`
`Estradiol
`
`Estradiol
`
`Estradiol
`Estradiol
`
`Estradiol
`
`For Injection
`
`
`
`
`
`20 mg/vial and
`40 mg/vial
` Transdermal System 0.025 mg/day,
`
` 0.0375 mg/day,
`
`
` 0.05 mg/days,
`
` 0.075 mg/day
`and 0.1 mg/day
`
` Transdermal System 0.0375 mg/day
`and 0.06
`mg/day
` Transdermal System 0.05 mg/day
`
`and 0.1 mg/day
`10 mcg
`Vaginal Tablets
` Transdermal System 0.0375 mg/day,
`
` 0.05 mg/day,
` 0.075 mg/day,
`0.1 mg/day
`Transdermal System 0.025 mg/day Minivelle
`
`Nexium IV
`
`Vivelle Dot
`
`Climara
`
`Climara
`
`Vagifem
`Minivelle
`
`11/23/2009
`
`4/27/2010
`
`9/12/2005
`
`1/2/2013
`8/18/2014
`
`5/8/2015
`
`Estradiol; Estradiol and
`Norgestimate
`Estradiol Valerate and
`Dienogest
`
`
`Eszopiclone
`
`Tablets
`
`Tablets
`
`Tablets
`
`Ethinyl Estradiol and
`Etonogestrel
`Etodolac
`
`Everolimus
`
`Vaginal Ring
`
`Extended-release
`Tablets
`Tablets
`
`Everolimus
`
`Tablets
`
`1 mg; 1 mg and
`0.09 mg
`3 mg;2 mg/2
`mg;2 mg/3 mg
`and 1 mg
`1 mg, 2 mg and
`3 mg
`
`0.015 mg/24
`hour and 0.12
`
`400 mg, 500 mg
`and 600 mg
`0.25 mg, 0.5
`mg, and 0.75
`mg
`10 mg
`
`Prefest
`
`Natazia
`
`10/22/2010
`
`Lunesta
`
`12/15/2008
`
`Nuvaring
`
`6/17/2013
`
`Lodine XL
`
`Zortress
`
`9/30/2013
`
`Afinitor
`
`6/18/2014
`
`Everolimus
`
`Tablets
`
` 2.5 mg, 5 mg,
`
`and 7.5 mg
`
`Afinitor
`
`12/10/2014
`
`Page 17
`
`PAGE 17 OF 52
`
`

`
`DRUG NAME
`
`Exenatide
`
`
`
`
` Par ag r aph IV Pat en t Cert if icat io n s
`
`
` Oc t o b er 6, 2015
`
`
`
`
`
`DOSAGE FORM
`
`STRENGTH
`
`RLD
`
`Injection
`
`Byetta
`
` DATE OF
`
`SUBMISSION
`6/11/2014
`
`Ezetimibe
`
`Tablets
`
`Ezetimibe and Simvastatin Tablets
`
`Famciclovir
`
`Famotidine
`
`Famotidine
`
`Famotidine
`
`Famotidine
`Famotidine
`
`Famotidine
`
`Febuxostat
`
`Felodipine
`
`Fenofibrate
`
`Fenofibrate
`
`Fenofibrate Choline
`
`Fenofibrate Choline
`
`Fenofibrate
`
`Fenofibrate
`
`Tablets
`
`Injection
`
`Injection
`
`Injection
`
`Tablets
`Tablets
`
`Tablets (Chewable)
`
`Tablets
`
`Extended-release
`Tablets
`Tablets
`
`Capsules
`
`Delayed-release
`Capsules
`Delayed-release
`Capsules
`Capsules
`
`Tablets
`
`250 mg/mL, 1.2
`mL and 2.4 mL
`prefilled syringe
`10 mg
`
`
`
`10 mg/10 mg,
`10 mg/20 mg,
`10 mg/40 mg
`and 10 mg/80
`mg
`125 mg