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Generated: June 25, 2017
What are the generic drug sources for doxycycline and what is the scope of doxycycline patent protection?
Doxycycline is the generic ingredient in seventeen branded drugs marketed by Galderma Labs Lp, Heritage Pharms Inc, Pfizer, Zydus Pharms Usa Inc, Rachelle, Mylan, Sandoz Inc, Lupin Ltd, Watson Labs, Aqua Pharms, G And W Labs Inc, Sun Pharm Inds Ltd, Chartwell Life Sci, Par Pharm, Impax Labs Inc, Sun Pharm Inds, Mylan Pharms Inc, Lannett, Hikma Intl Pharms, Mylan Labs Ltd, Mutual Pharm, Halsey, Actavis Labs Fl Inc, Pvt Form, Aqua Pharms Llc, Actavis Elizabeth, Vintage Pharms, Collagenex, West-ward Pharms Int, Tolmar, Warner Chilcott, Heather, Interpharm, Ivax Sub Teva Pharms, Mayne Pharma Inc, Superpharm, Caribe Holdings, Fresenius Kabi Usa, Ranbaxy, Medicis, Teva, Mayne Pharma Intl, Epic Pharma Llc, Pliva, Larken Labs, Amneal Pharms, Prinston Inc, and Mayne Pharma, and is included in ninety NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 17 |
| Patents: | 18 |
| Applicants: | 48 |
| NDAs: | 90 |
| Drug Master File Entries: see list | 27 |
| Suppliers / Packagers: see list | 39 |
| Bulk Api Vendors: see list | 31 |
| Clinical Trials: see list | 218 |
| Patent Applications: see list | 2,079 |
| Therapeutic Class: | Dermatological Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | doxycycline at DailyMed |
| Ingredient-type | Tetracyclines |
| Drug Class | Tetracycline-class Drug |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 40MG | CAPSULE;ORAL |
| ► Subscribe | ► Subscribe | 40MG | CAPSULE; ORAL |
| ► Subscribe | ► Subscribe | 40MG | CAPSULE;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090431-004 | Apr 29, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Prinston Inc | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 207494-002 | Nov 15, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Lannett | DOXYCYCLINE | doxycycline | TABLET;ORAL | 065285-001 | Dec 8, 2005 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sun Pharm Inds Ltd | DOXYCYCLINE | doxycycline | TABLET;ORAL | 065356-001 | May 31, 2006 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Heritage Pharms Inc | DOXYCYCLINE | doxycycline | TABLET;ORAL | 091605-004 | Dec 20, 2011 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 5,789,395 | ► Subscribe | ||||||||||||||||||||||
Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 5,919,775 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,014,858 | Use methods of treating acne and telangiectasia | ► Subscribe | |||||||||||||||||||||||||||
| 8,658,189 | Methods of treating acne | ► Subscribe | |||||||||||||||||||||||||||
| 8,052,983 | Methods of treating acne | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2004536046 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2204168 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2534827 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1383508 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2221056 | ► 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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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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