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Generated: July 22, 2017
What is the competitive landscape for ANI PHARMS INC, and when can generic versions of ANI PHARMS INC drugs launch?
ANI PHARMS INC has one hundred and twenty-one approved drugs.| Patents: | 1 |
| Tradenames: | 63 |
| Ingredients: | 59 |
| NDAs: | 121 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ani Pharms Inc | PERPHENAZINE | perphenazine | TABLET;ORAL | 089457-001 | Sep 10, 1987 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Ani Pharms Inc | DEXCHLORPHENIRAMINE MALEATE | dexchlorpheniramine maleate | TABLET;ORAL | 088682-001 | Jan 17, 1986 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Ani Pharms Inc | DESIPRAMINE HYDROCHLORIDE | desipramine hydrochloride | TABLET;ORAL | 071803-004 | Dec 8, 1987 | RX | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Ani Pharms Inc | TESTOSTERONE | testosterone | GEL;TRANSDERMAL | 202763-001 | Feb 14, 2012 | BX | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Ani Pharms Inc | ETODOLAC | etodolac | CAPSULE;ORAL | 075126-002 | Sep 16, 1999 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ani Pharms Inc | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-002 | Approved Prior to Jan 1, 1982 | 4,011,258 | ► Subscribe | ||||||||||||||||||||||
Ani Pharms Inc | INDERAL LA | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 018553-004 | Mar 18, 1987 | 4,138,475 | ► Subscribe | ||||||||||||||||||||||
Ani Pharms Inc | LITHOBID | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 018027-001 | Approved Prior to Jan 1, 1982 | 4,264,573 | ► Subscribe | ||||||||||||||||||||||
Ani Pharms Inc | INDERAL LA | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 018553-002 | Apr 19, 1983 | 4,138,475 | ► Subscribe | ||||||||||||||||||||||
Ani Pharms Inc | BRETHINE | terbutaline sulfate | TABLET;ORAL | 017849-001 | Approved Prior to Jan 1, 1982 | 4,011,258 | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,040,086 | Timed, sustained release systems for propranolol | ► Subscribe | |||||||||||||||||||||||||||
| 9,358,214 | Timed, sustained release systems for propranolol | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2333306 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA04003234 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20041740 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101090719 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60233668 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0443983/03 | Switzerland | ► Subscribe | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 | ||||||||||||||||||||||||||
| 292 | Luxembourg | ► Subscribe | PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE | ||||||||||||||||||||||||||
| C0008 | Belgium | ► Subscribe | PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208 | ||||||||||||||||||||||||||
| C0005 | Belgium | ► Subscribe | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 | ||||||||||||||||||||||||||
| 14/008 | Ireland | ► Subscribe | PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919 | ||||||||||||||||||||||||||
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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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