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Serving 500+ biopharmaceutical companies globally:
Generated: July 22, 2017
What is the competitive landscape for PFIZER, and what generic alternatives to PFIZER drugs are available?
PFIZER has one hundred and fifty-five approved drugs.| Patents: | 58 |
| Tradenames: | 122 |
| Ingredients: | 107 |
| NDAs: | 155 |
| Drug Master File Entries: (click here to view) | 3 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | TETRACYN | tetracycline hydrochloride | INJECTABLE;INJECTION | 060096-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Pfizer | EXUBERA | insulin recombinant human | POWDER;INHALATION | 021868-001 | Jan 27, 2006 | DISCN | No | No | 6,546,929 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | AP | RX | Yes | Yes | 6,794,370*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Pfizer Inc | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-001 | Aug 19, 2016 | RX | No | No | 8,685,443 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-010 | Jul 29, 2004 | AB | RX | Yes | No | 5,969,156*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-008 | Jan 30, 2004 | 6,126,971*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-008 | Jan 30, 2004 | 4,879,303*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer Pharms | REZULIN | troglitazone | TABLET;ORAL | 020720-003 | Aug 4, 1997 | 5,478,852 | ► Subscribe | ||||||||||||||||||||||
Pfizer | CADUET | amlodipine besylate; atorvastatin calcium | TABLET;ORAL | 021540-001 | Jan 30, 2004 | RE40667*PED | ► Subscribe | ||||||||||||||||||||||
Pfizer | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | 5,969,156*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
tofacitinib | Extended-release Tablets | 11 mg | XELJANZ XR | 11/7/2016 |
ibuprofen and diphenhydramine citrate | Capsules | 200 mg/38 mg | ADVIL PM | 2/16/2016 |
dofetilide | Capsules | 0.125 mg, 0.25 mg, and 0.5 mg | TIKOSYN | 5/1/2014 |
fesoterodine fumarate | Extended-release Tablets | 4 mg and 8 mg | TOVIAZ | 10/31/2012 |
nitroglycerin | Sublingual Tablets | 0.6 mg | NITROSTAT | 12/29/2011 |
azithromycin | For Injection | 500 mg/vial | ZITHROMAX | 6/17/2011 |
varenicline tartrate | Tablets | 0.5 mg and 1 mg | CHANTIX | 5/10/2010 |
eletriptan hydrobromide | Tablets | 20 mg and 40 mg | RELPAX | 3/29/2010 |
amlodipine besylate and atorvastatin calcium | Tablets | 2.5 mg/40 mg | CADUET | 9/17/2009 |
amlodipine besylate and atorvastatin calcium | Tablets | 5 mg/80 mg | CADUET | 4/7/2009 |
amlodipine besylate and atorvastatin calcium | Tablets | 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 | CADUET | 12/29/2006 |
sertraline hydrochloride | Tablets | 150 mg and 200 mg | ZOLOFT | 11/9/2005 |
nitroglycerin | Sublingual Tablets | 0.3 mg, 0.4 mg and 0.6 mg | NITROSTAT | 10/19/2005 |
zaleplon | Capsules | 5 mg and 10 mg | SONATA | 6/21/2005 |
ziprasidone hydrochloride | Capsules | 20 mg, 40 mg, 60 mg and 80 mg | GEODON | 2/7/2005 |
ibuprofen potassium and pseudoephedrine hydrochloride | Capsules | 200 mg/30 mg | ADVIL COLD AND SINUS | 12/27/2004 |
sildenafil citrate | Tablets | 25 mg and 50 mg | VIAGRA | 11/19/2004 |
sildenafil citrate | Tablets | 100 mg | VIAGRA | 10/25/2004 |
irinotecan hydrochloride | Injection | 20 mg/mL, 2 mL and 5 mL vials | CAMPTOSAR | 7/26/2004 |
| Patent Number | Expiration Date |
|---|---|
| ► Subscribe | ► Subscribe |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,592,904 | Dispersible macromolecule compositions and methods for their preparation and use | ► Subscribe | |||||||||||||||||||||||||||
| 6,372,258 | Methods of spray-drying a drug and a hydrophobic amino acid | ► Subscribe | |||||||||||||||||||||||||||
| 5,545,413 | Dosage form for administering oral hypoglycemic glipizide | ► Subscribe | |||||||||||||||||||||||||||
| 7,470,698 | Adenosine A3 receptor modulators | ► Subscribe | |||||||||||||||||||||||||||
| 8,883,217 | Modified release formulations containing drug-ion exchange resin complexes | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 0940154 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2904588 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 200100285 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1259489 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 045528 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0035 | France | ► Subscribe | PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121 | ||||||||||||||||||||||||||
| /1997 | Austria | ► Subscribe | PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107 | ||||||||||||||||||||||||||
| C0013 | France | ► Subscribe | PRODUCT NAME: ELETRIPTAN HYDROBROMIDE; NAT. REGISTRATION NO/DATE: NL 26625 20011105; FIRST REGISTRATION: LI - IKS 55218 20001214 | ||||||||||||||||||||||||||
| C0009 | France | ► Subscribe | PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927 | ||||||||||||||||||||||||||
| C0039 | France | ► Subscribe | PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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