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Generated: July 22, 2017
What is the competitive landscape for HOSPIRA, and what generic alternatives to HOSPIRA drugs are available?
HOSPIRA has five hundred and seven approved drugs.| Patents: | 7 |
| Tradenames: | 326 |
| Ingredients: | 200 |
| NDAs: | 507 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | VERAPAMIL HYDROCHLORIDE | verapamil hydrochloride | INJECTABLE;INJECTION | 070740-001 | May 6, 1987 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hospira | VECURONIUM BROMIDE | vecuronium bromide | INJECTABLE;INJECTION | 075164-002 | Oct 21, 1999 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hospira | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 018096-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hospira | NITROGLYCERIN IN DEXTROSE 5% | nitroglycerin | INJECTABLE;INJECTION | 074083-001 | Oct 26, 1994 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hospira | LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 088329-001 | May 17, 1984 | AP | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira Inc | NIPENT | pentostatin | INJECTABLE;INJECTION | 020122-001 | Oct 11, 1991 | 3,923,785 | ► Subscribe | ||||||||||||||||||||||
Hospira | TRACRIUM PRESERVATIVE FREE | atracurium besylate | INJECTABLE;INJECTION | 018831-001 | Nov 23, 1983 | 4,179,507 | ► Subscribe | ||||||||||||||||||||||
Hospira | BRETYLOL | bretylium tosylate | INJECTABLE;INJECTION | 017954-001 | Approved Prior to Jan 1, 1982 | RE29618 | ► Subscribe | ||||||||||||||||||||||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | 4,910,214*PED | ► Subscribe | ||||||||||||||||||||||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | 5,344,840 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
dexmedetomidine | Injection | 4 mcg/mL, 20 mL vials | PRECEDEX | 9/30/2015 |
dexmedetomidine | Injection | 4 mcg/mL, 50 mL and 100 mL vials | PRECEDEX | 12/26/2013 |
argatroban in sodium chloride | Injection | 1 mg/mL, 50 mL vials | ARGATROBAN | 12/16/2011 |
dexmedetomidine | Injection | 100 mcg/mL | PRECEDEX | 4/8/2009 |
argatroban | Injection | 100 mg/mL, 2.5 mL vials | ARGATROBAN | 9/24/2007 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,436,033 | Methods of treatment using a dexmedetomidine premix formulation | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hungary | 229162 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 201630603 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 552136 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5927680 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2013201069 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB03/033 | United Kingdom | ► Subscribe | PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321 | ||||||||||||||||||||||||||
| 14/032 | Ireland | ► Subscribe | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 | ||||||||||||||||||||||||||
| C0021 | France | ► Subscribe | PRODUCT NAME: PEGAPTANIB EN PARTICULIER SOUS FORME DE SON SEL DE SODIUM; REGISTRATION NO/DATE IN FRANCE: EU/1/05/325/001 DU 20060131; REGISTRATION NO/DATE AT EEC: EU/1/05/325/001 DU 20060131 | ||||||||||||||||||||||||||
| 70017 | Netherlands | ► Subscribe | PRODUCT NAME: TOPOTECAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, HYDRAAT OF SOLVAAT, IN HET BIJZONDER HET HYDROCHLORI DE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 - EU/1/96/027/002 19961112; FIRST REGISTRATION: CH IKS 53857 19961016 | ||||||||||||||||||||||||||
| C/GB11/055 | United Kingdom | ► Subscribe | PRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720 | ||||||||||||||||||||||||||
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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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