Doxycycline Patent Expiration

Doxycycline is Used for treating inflammatory lesions of rosacea. It was first introduced by Pfizer Laboratories Div Pfizer Inc in its drug Vibramycin on Approved Prior to Jan 1, 1982. Other drugs containing Doxycycline are Monodox, Oracea. 27 different companies have introduced drugs containing Doxycycline.


Doxycycline Patents

Given below is the list of patents protecting Doxycycline, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Oracea US7749532 Once daily formulations of tetracyclines Dec 19, 2027 Galderma Labs Lp
Oracea US8206740 Once daily formulations of tetracyclines Dec 24, 2025

(Expired)

Galderma Labs Lp
Oracea US8394405 Once daily formulations of tetracyclines Apr 07, 2024

(Expired)

Galderma Labs Lp
Oracea US8394406 Once daily formulations of tetracyclines Apr 07, 2024

(Expired)

Galderma Labs Lp
Oracea US8470364 Once daily formulations of tetracyclines Apr 07, 2024

(Expired)

Galderma Labs Lp
Oracea US8709478 Once daily formulations of tetracyclines Apr 07, 2024

(Expired)

Galderma Labs Lp
Oracea US10058564 Methods of treating acne Apr 05, 2022

(Expired)

Galderma Labs Lp
Oracea US7211267 Methods of treating acne Apr 05, 2022

(Expired)

Galderma Labs Lp
Oracea US7232572 Methods of treating rosacea Apr 05, 2022

(Expired)

Galderma Labs Lp
Oracea US8603506 Methods of treating acne Apr 05, 2022

(Expired)

Galderma Labs Lp
Oracea US9241946 Methods of treating acne Apr 05, 2022

(Expired)

Galderma Labs Lp
Oracea US5789395 Method of using tetracycline compounds for inhibition of endogenous nitric oxide production Aug 30, 2016

(Expired)

Galderma Labs Lp
Oracea US5919775 Method for inhibiting expression of inducible nitric oxide synthase with tetracycline Aug 30, 2016

(Expired)

Galderma Labs Lp



Doxycycline's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Doxycycline:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Doxycycline in Type II Diabetes Mostafa Bahaa NA COMPLETED
(Sep 1, 2026)
PHASE1, PHASE2
Characterization of Doxycycline Pharmacokinetics and Adherence HIV Prevention Trials Network NA ENROLLING BY INVITATION
(Sep 1, 2026)
PHASE1
Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)? Montefiore Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE1
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Multicentre Study Evaluating the Efficacy of a 7-day Course of Doxycycline for the Treatment of Asymptomatic Anal Lymphogranuloma Venereum. University Hospital, Bordeaux NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Investigation of Laser Assisted Drug Delivery of NanoDOX® Massachusetts General Hospital NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II) PolyPid Ltd. NA COMPLETED
(Jun 1, 2026)
PHASE3
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy HIV Prevention Trials Network NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
A Pilot of Pediatric/Adult Study of Gene Expression Profiling and Clinical Characterization of Phototoxicity National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) NA COMPLETED
(May 29, 2026)
PHASE1
Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease Hawaii Pacific Health NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway University of California, San Francisco NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment International Extranodal Lymphoma Study Group (IELSG) NA COMPLETED
(Apr 1, 2026)
PHASE2
Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Doxycycline to Protect Heart Muscle After Heart Attacks University of Alberta NA COMPLETED
(Apr 1, 2026)
PHASE2
Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP) ANRS, Emerging Infectious Diseases NA COMPLETED
(Apr 1, 2026)
PHASE3
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)" University of Washington NA RECRUITING
(Apr 1, 2026)
PHASE2
Doxycycline Use in Post-Operative Seromas University of Miami NA RECRUITING
(Apr 1, 2026)
PHASE2
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery. PolyPid Ltd. NA COMPLETED
(Mar 1, 2026)
PHASE1, PHASE2
Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University NA TERMINATED
(Mar 1, 2026)
PHASE2
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection PolyPid Ltd. NA COMPLETED
(Mar 1, 2026)
PHASE2
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection PolyPid Ltd. NA COMPLETED
(Mar 1, 2026)
PHASE3
MMP-9 Inhibition for Recalcitrant Wet AMD University of Iowa NA RECRUITING
(Mar 1, 2026)
PHASE2
Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions) Life Biosciences Inc. NA RECRUITING
(Mar 1, 2026)
PHASE1


Doxycycline Generic API Manufacturers

Several generic applications have been filed for Doxycycline. The first generic version for Doxycycline was by Rachelle Laboratories Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Aiping Pharmaceutical Inc and was approved on Oct 1, 2025.

Given below is the list of companies who have filed for Doxycycline generic, along with the locations of their manufacturing plants worldwide.


Doxycycline News

CDSCO Requires Revisions to Doxycycline and Carbimazole Prescribing Information to ...

20 Feb, 2026

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