Last Updated: August 10, 2026

YASMIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Yasmin, and when can generic versions of Yasmin launch?

Yasmin is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in YASMIN is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for YASMIN?
  • What are the global sales for YASMIN?
  • What is Average Wholesale Price for YASMIN?
Recent Clinical Trials for YASMIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hansoh BioMedical R&D CompanyPHASE1
Bio-innova Co., LtdPHASE1
Boehringer IngelheimPHASE1

See all YASMIN clinical trials

Paragraph IV (Patent) Challenges for YASMIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
YASMIN Tablets drospirenone; ethinyl estradiol 3 mg/0.03 mg 021098 1 2005-01-07

US Patents and Regulatory Information for YASMIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 YASMIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 5,569,652 ⤷  Start Trial
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 6,933,395 ⤷  Start Trial
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 6,787,531 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for YASMIN

See the table below for patents covering YASMIN around the world.

Country Patent Number Title Estimated Expiration
Austria 154881 ⤷  Start Trial
Australia 5509490 ⤷  Start Trial
Australia 642876 ⤷  Start Trial
Brazil 1101055 ⤷  Start Trial
Canada 2016780 DIHYDROSPIRORENONE ANTIANDROGENIQUE (DIHYDROSPIRORENONE AS AN ANTIANDROGEN) ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for YASMIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 91065 Luxembourg ⤷  Start Trial 91065, EXPIRES: 20150516
0398460 SPC/GB04/032 United Kingdom ⤷  Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0398460 CA 2001 00011 Denmark ⤷  Start Trial
0398460 300221 Netherlands ⤷  Start Trial 300221, 20100516, EXPIRES: 20150306
0398460 C00398460/01 Switzerland ⤷  Start Trial FORMER OWNER: SCHERING AKTIENGESELLSCHAFT, DE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: July 30, 2026

Yasmin (drospirenone/ethinyl estradiol) market dynamics and financial trajectory

Executive summary: YASMIN (drospirenone/ethinyl estradiol) is a combined oral contraceptive (COC) with mature, largely generic-driven economics in the US. Publicly reported financial performance is typically limited because the brand is no longer a peak-growth product for its originator, and today’s market is shaped by (1) generic penetration, (2) payer and pharmacy substitution behavior, (3) safety signal management for COCs (including venous thromboembolism risk), and (4) competitive brand positioning versus other drospirenone and non-drospirenone COCs. Net sales trajectory is dominated by category maturity rather than new competitive entries, with the main “financial levers” being formulary placement of generics, copay dynamics, and switching between equivalent COCs.


How has YASMIN performed financially over time versus other oral contraceptives?

Direct financial disclosures for “YASMIN” as a standalone brand are limited in public filings once brand sales fall below materiality thresholds. In practice, YASMIN’s financial trajectory tracks the US COC class: early brand growth, then steady decline as approved generics captured price-sensitive segments, followed by stabilization at lower sales levels driven by inertia, patient preference, and payer contracting that still sometimes favors specific SKUs.

What typically drives YASMIN’s revenue trajectory in a mature COC category

  • Generic substitution at the pharmacy level: YASMIN’s active ingredients (drospirenone and ethinyl estradiol) face multiple generic equivalents and AB-rated products as patents expire, which compresses net price.
  • Formulary churn and tier management: Medicaid and commercial payers often move COCs onto preferred generic lists, pushing patients into equivalent lower-cost products unless a “brand-only” restriction or prior authorization exists.
  • Safety communications and risk perception: COCs carry class warnings for thromboembolic risk. Brand choice can shift when prescribers/patients react to labeling prominence and media coverage, even when absolute risk differences are small.
  • Package and adherence economics: Rebates, copay cards (where permitted), and preferred pharmacy networks influence effective transaction volume rather than changes in medical need.

How YASMIN competes in the COC competitive set

YASMIN’s competitive universe includes:

  • Other drospirenone/ethinyl estradiol COCs (often generic): competing largely on price and payer preference.
  • Levonorgestrel, norgestimate, and desogestrel-based COCs: competing through formulary positioning, clinician habits, and patient tolerability profiles.
  • Brand COCs with ongoing sales (in some markets): these can capture share when payers carve out preferred brands or when patients stay with a known product.

Net effect: brand-level revenues trend downward as generic multiples expand, then stabilize at a smaller “brand remaining” slice.


What market dynamics shape YASMIN demand in the US?

Key demand variables for mature COCs are payer economics and switching behavior, not incremental clinical differentiation.

Payer and channel dynamics

  • Formulary placement: Preferred generics reduce brand volume. YASMIN’s share is sensitive to whether drospirenone/ethinyl estradiol generics sit on low tiers.
  • Cash price vs. net price: For patients without strong insurance coverage, the list price matters less once generics dominate; net price becomes the key.
  • PBM contracting and pharmacy inventory: Once preferred generics are stocked and promoted via dispensing incentives, switching happens at the point of sale.

Patient and prescriber switching dynamics

  • Therapeutic equivalence labeling: Generic substitution is legally and clinically facilitated because products are bioequivalent and therapeutically equivalent under FDA standards.
  • Tolerability-driven persistence: Patients with migraines, acne control needs, or prior experience may remain on a specific COC if coverage remains.
  • Adverse event sensitivity: Venous thromboembolism (VTE) labeling increases caution in prescribing, which can reduce COC continuation for some patients and shift them to different options.

Regulatory and safety framing

COCs’ boxed warnings and labeling updates influence risk-benefit counseling. Over time, shifts in prescriber behavior can change category mix (type of progestin selection), even when YASMIN is not the only exposed product.


When does YASMIN lose exclusivity and how does that impact pricing and volume?

In a mature market, the exclusivity story is mainly about the transition from brand-led sales to generic-led pricing. For YASMIN’s financial trajectory, the “inflection” occurs at the combination of:

  1. patent expirations for the formulation or composition, and
  2. the availability of approved generics that force net price compression.

Why exclusivity timelines matter less after launch maturity

Once multiple AB-rated generics exist, any remaining exclusivity on brand-specific patents may delay a full price reset, but volume usually migrates to the lowest-cost equivalent already available under payer rules.

What typically happens after exclusivity gaps close

  • Gross-to-net price erosion: Brand net price falls due to rebates and contracting pressure.
  • Share compression: If generics are preferred, brand share drops quickly.
  • Remaining brand niche: Residual brand demand persists through coverage exceptions, patient preference, or clinician prescribing inertia.

What is the Orange Book status of YASMIN and how many patents cover it?

Orange Book status is the central map for exclusivity and generic entry risk for YASMIN. The number of listed patents (composition, method-of-use, and formulation) determines the timing and strength of barriers for generic manufacturers and potential Paragraph IV filings.

How to interpret Orange Book patent structure for COCs

For combination oral contraceptives like YASMIN, Orange Book listings commonly include:

  • Drug substance and formulation patents (composition of matter and specific formulation)
  • Method-of-use patents (when present)
  • Manufacturing or process-related patents (less common as determinants for generic launch in settled molecules)

Practical implications for market dynamics

  • The faster patents fall away, the faster payers and PBMs shift to generics.
  • Patent “thickets” can slow entry, but in mature COCs the outcome usually becomes generic equilibrium with limited residual brand pricing power.

Which companies compete with YASMIN and what are the main substitution risks?

The competitive battlefield is dominated by generic manufacturers of drospirenone/ethinyl estradiol equivalents plus COCs based on alternative progestins.

Substitution risks that directly reduce YASMIN unit volume

  • AB substitution at the pharmacy counter
  • Tier and prior authorization policies
  • Switching during plan renewals

Competitive positioning patterns

  • Cost leadership: PBMs typically steer to the lowest net-price equivalent.
  • Clinical switching: Prescribers may adjust progestin type based on patient risk profile.
  • Brand switching among remaining brand users: Patients may migrate to a competitor brand if it retains better coverage.

What generic entry risks exist for YASMIN (including Paragraph IV)?

Paragraph IV risk matters most around patent expiry windows. Once generic drospirenone/ethinyl estradiol products are widely available, incremental entry risks reduce to:

  • launching under different strengths/pack sizes,
  • marketing-channel targeting, and
  • manufacturing-line capacity and supply stability.

How Paragraph IV filings typically change market behavior

  • If a strong Orange Book patent is challenged and loses: rapid entry and price compression.
  • If litigation leads to delayed launch: brand stability can extend.
  • Settlement-driven entry timing: generics may enter at a scheduled date with constrained competitive overlap.

What to expect in a mature COC market

Even with new entrants, the market’s core dynamic is already generic-driven. The risk is not “whether generics exist,” but whether additional entrants further erode net price and concentrate dispensing incentives toward lower-cost SKUs.


How strong is the patent estate for YASMIN and what does that mean for licensing?

Patent strength for a mature COC generally translates into:

  • how long a brand retains contracted pricing leverage, and
  • whether licensing deals with generics extend exclusivity-like economics.

Typical COC patent estate outcomes

  • As composition and formulation barriers expire, the brand’s remaining protection often becomes narrow.
  • Litigation leverage tends to weaken once multiple generics are already approved and sold.

Licensing and settlement economics

In COCs, licensing is commonly less about “creating a new revenue engine” and more about settling specific patent disputes to manage launch timing and avoid protracted margin erosion.


What patent litigation affects YASMIN and how does it shape the competitive timeline?

YASMIN’s legal landscape affects:

  • start dates for generic launches,
  • whether multiple generics enter simultaneously,
  • and how quickly payer switching occurs.

How litigation history influences market dynamics

  • Earlier settlement: earlier generic entry, faster price compression.
  • Long litigation: slower entry, longer brand pricing stability.
  • Multiplicity of patents: even after some patents expire, remaining patents can delay launch for specific label or manufacturing changes.

What FDA regulatory status does YASMIN hold and does it affect commercialization?

YASMIN is an FDA-approved COC. For a mature prescription product, regulatory status affects:

  • manufacturing changes and labeling maintenance,
  • periodic updates to safety labeling,
  • and generics’ ability to rely on the reference product.

Patient-facing implications

Regulatory updates do not change “clinical need,” but they can impact:

  • prescriber comfort,
  • switching to other COCs,
  • and persistence rates.

How do formulations and product formats influence YASMIN’s market performance?

For COCs, product format affects:

  • pharmacy stocking,
  • patient adherence via pill pack convenience,
  • and differentiability at the pharmacy counter (even among therapeutically equivalent products).

What matters commercially

  • Pack size and strength options: can influence which SKUs are in stock and which are in preferred formularies.
  • Manufacturing reliability: supply disruptions can temporarily boost share for remaining stable SKUs, but in COCs supply issues are usually short-lived.

How does YASMIN compare with other drospirenone/ethinyl estradiol products in commercial terms?

In most therapeutic and regulatory respects, drospirenone/ethinyl estradiol products are substitutable. The differentiators are:

  • net cost under payer contracts,
  • availability,
  • marketing support (if any brand remains),
  • and patient persistence.

Practical comparison framework

  • If payer prefers generics: YASMIN performs worse than equivalent generics.
  • If payer covers the brand without meaningful copay pressure: YASMIN can retain a niche share.
  • If safety communications shift prescribing away from certain risk profiles: net demand can shift across the whole COC class, affecting drospirenone-based products.

Key Takeaways

  • YASMIN’s financial trajectory is dominated by generic substitution and payer economics rather than new clinical differentiation.
  • Market dynamics hinge on formulary placement, PBM contracting, and pharmacy-level AB substitution, which drive price compression and unit volume erosion after exclusivity windows.
  • Orange Book and litigation timing are the main levers for generic entry, but in a mature COC market the number of approved equivalents becomes the practical driver of pricing.
  • Commercial performance is sensitive to safety risk perception and prescriber counseling, which can affect COC persistence and cross-switching to other progestins.

FAQs

1) What drives YASMIN net sales in a generic-dominated COC market?
Payer formulary placement, PBM tier status for equivalent drospirenone/ethinyl estradiol products, and pharmacy dispensing incentives that favor lowest net-cost AB substitutes.

2) Do YASMIN generic competitors usually launch simultaneously, or are entry dates staggered?
Entry timing is typically driven by patent expiration and litigation outcomes, which can stagger market entry by specific patent sets, strengths, and label-manufacturing approvals.

3) Does YASMIN’s safety labeling materially change demand versus other COCs?
It can affect prescriber selection and patient persistence across the COC class, changing mix among progestin types based on risk counseling behavior.

4) Can YASMIN retain revenue even after major patents expire?
Yes, through residual brand preference, coverage exceptions, and inertia among patients who remain on the same SKU when copays remain manageable.

5) What are the biggest operational barriers for generics trying to capture YASMIN share?
Regulatory pathway execution tied to Orange Book patent status, manufacturing reliability for stable supply, and payer contracting that determines whether a generic becomes preferred.


References

  1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
  2. U.S. FDA Prescribing Information for YASMIN (drospirenone and ethinyl estradiol) and related safety labeling updates. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.