HABITROL Drug Patent Profile
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When do Habitrol patents expire, and when can generic versions of Habitrol launch?
Habitrol is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.
The generic ingredient in HABITROL is nicotine. There are thirty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicotine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Habitrol
A generic version of HABITROL was approved as nicotine by DIFGEN PHARMS on October 20th, 1997.
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Questions you can ask:
- What is the 5 year forecast for HABITROL?
- What are the global sales for HABITROL?
- What is Average Wholesale Price for HABITROL?
Summary for HABITROL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 11 |
| Patent Applications: | 4,112 |
| What excipients (inactive ingredients) are in HABITROL? | HABITROL excipients list |
| DailyMed Link: | HABITROL at DailyMed |
Recent Clinical Trials for HABITROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NYU Langone Health | Phase 1 |
| University of Virginia | N/A |
| Ohio State University | Phase 1/Phase 2 |
Pharmacology for HABITROL
| Drug Class | Cholinergic Nicotinic Agonist |
US Patents and Regulatory Information for HABITROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-004 | Nov 12, 1999 | OTC | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-005 | Nov 12, 1999 | OTC | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-006 | Nov 12, 1999 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for HABITROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-004 | Nov 12, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-005 | Nov 12, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-005 | Nov 12, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-006 | Nov 12, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-006 | Nov 12, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-006 | Nov 12, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Dr Reddys Labs Sa | HABITROL | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020076-005 | Nov 12, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HABITROL
See the table below for patents covering HABITROL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0498468 | Dispositif pour l'administration de nicotine par voie transcutanĂ©e (Device for transcutaneous application of nicotine) | ⤷ Sign Up |
| European Patent Office | 0246385 | TRANSCUTANEOUS APPLICATION OF NICOTINE | ⤷ Sign Up |
| Austria | 88366 | ⤷ Sign Up | |
| Germany | 3650575 | ⤷ Sign Up | |
| Singapore | 132393 | ⤷ Sign Up | |
| Austria | 143277 | ⤷ Sign Up | |
| Germany | 498468 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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 verification 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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